- Smilow Cancer Hospital Phase I Unit55 Park StreetSte First FloorNew Haven, CT 06511
Patricia LoRusso, DO
Medical Oncology
Telehealth is available
Patient type treated
Adult
Accepting new patients
Yes
Referral required
From patients or physicians
Board Certified in
Internal Medicine and Medical Oncology
Biography
Oncologist Patricia LoRusso, DO, associate director of innovative medicine at Yale Medicine, has expertise in testing new treatments on patient volunteers who have advanced stages of cancer. Her passion is bringing research breakthroughs into the clinic to help patients with different types and stages of cancer.
The clinical trials at Yale Cancer Center offer access to experimental drugs that are sometimes a patient’s last and best hope, says Dr. LoRusso. Therapies that prove successful can advance through the U.S. Food and Drug Administration approval process. “Many of the drugs tested here will help generations of cancer patients,” says Dr. LoRusso. In her career, 14 cancer drugs she has performed clinical trials on, which she refers to as her “children,” have gone on to gain FDA approval.
Dr. LoRusso leads the Phase I clinical trials infusion center at Smilow Cancer Hospital at Yale New Haven. She infuses the center with a warm, team-focused approach that puts patients at the center of care. “We’re improving patients’ lives in Connecticut and beyond,” says Dr. LoRusso.
Titles
- Amy and Joseph Perella Professor of Medicine (Medical Oncology)
- Chief, Experimental Therapeutics
- Associate Cancer Center Director, Experimental Therapeutics
Education & Training
- MAYale University (2015)
- FellowshipWayne State University (1988)
- ResidencyRiverside Osteopathic Hospital (1984)
- InternshipRiverside Osteopathic Hospital (1982)
- DOMichigan State University (1981)
- BSMarygrove College (1977)
Additional Information
Honors & Recognitions
- Fellow: American Society of Clinical Oncology (ASCO) (2022)
- Joseph H. Burchenal Award for Outstanding Achievement in Clinical Cancer Research: American Association for Cancer Research (2022)
Board Certifications
- American Osteopathic Board of Internal Medicine, Medical Oncology (1991)
- American Osteopathic Board of Internal Medicine, Internal Medicine (1987)
Publications
- Shimizu T, Powderly J, Razak A, LoRusso P, Miller K, Kao S, Kongpachith S, Tribouley C, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman R, Golan T, Tolcher A. First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors. Frontiers In Oncology 2024, 14: 1376551. DOI: 10.3389/fonc.2024.1376551.
- Yap T, Dowlati A, Dagogo-Jack I, Vibert J, Spira A, Garcia V, Punekar S, Calvo E, Sonpavde G, Awad M, Riess J, Hernández-Guerrero T, Herzberg B, Italiano A, Swalduz A, LoRusso P, Smit E, Garon E, Novotny W, Guo R. 1 Oral: First Clinical Results from A Phase 1 Trial of PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Patients with Advanced Solid Tumors with a SMARCA4 Mutation. European Journal Of Cancer 2024, 211: 114530. DOI: 10.1016/j.ejca.2024.114530.
- 616MO Long-term follow-up of single-agent divarasib in patients with KRAS G12C-positive solid tumorsGarralda E, Patel M, Kim T, Sacher A, Forster M, Santoro A, Desai J, Paz-Ares L, Gonzalez A, De Miguel M, Bowyer S, Dziadziuszko R, Kim S, Han S, Krebs M, Lorusso P, Cosman R, Chang J, Jun T, Miller W. 616MO Long-term follow-up of single-agent divarasib in patients with KRAS G12C-positive solid tumors. Annals Of Oncology 2024, 35: s494. DOI: 10.1016/j.annonc.2024.08.683.
- Park W, Kasi A, Spira A, Berlin J, Wang J, Herzberg B, Kuboki Y, Kitano S, Pelster M, Goldman J, Morgensztern D, Kondo S, Jänne P, Fujii H, Lee H, Gill S, Saci A, Lorusso P, Tolcher A. 608O Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC). Annals Of Oncology 2024, 35: s486-s487. DOI: 10.1016/j.annonc.2024.08.675.
- Wentzel K, Peguero J, Kummar S, Lorusso P, Mehnert J, Spira A, Naing A, Hamid O, Mehmi I, Benhadji K, Alland L, Hu X, Xiao H, Bao X, Chen J, Gong Y, Liu X. 1000MO A phase I/II, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors. Annals Of Oncology 2024, 35: s680-s681. DOI: 10.1016/j.annonc.2024.08.1059.
- Lorusso P, Meric-Bernstam F, Hafez N, Rivera I, Tripathy D, Wilks S, Pearson P, Needle M, Tolcher A. 669P CBX-12-101: Final results of a phase I study of CBX-12, a peptide drug conjugate (PDC) in patients (pts) with metastatic solid tumors. Annals Of Oncology 2024, 35: s525. DOI: 10.1016/j.annonc.2024.08.735.
- Guo R, Dowlati A, Dagogo-Jack I, Vibert J, Spira A, Garcia V, Punekar S, Calvo E, Sonpavde G, Awad M, Riess J, Guerrero T, Herzberg B, Italiano A, Swalduz A, Lorusso P, Smit E, Garon E, Novotny W, Yap T. 603O First clinical results from a phase I trial of PRT3789: A first-in-class intravenous SMARCA2 degrader, in patients with advanced solid tumors with a SMARCA4 mutation. Annals Of Oncology 2024, 35: s483-s484. DOI: 10.1016/j.annonc.2024.08.670.
- Luke J, Gao X, Olszanski A, Sanborn R, Falchook G, Patel S, Bedard P, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Ramesh R, Xu R, Wu B, Ding K, Raizer J, Lorusso P. 996MO Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced/metastatic solid tumors: Data from phase I dose escalation. Annals Of Oncology 2024, 35: s678-s679. DOI: 10.1016/j.annonc.2024.08.1055.
- Perets R, Stemmer S, Geva R, Golan T, Fakih M, Cohen J, Lieu C, Jin Z, Lorusso P, Friedman I, Hakim M, Ziv D, Hashmueli S, Mandel I, Moshe T, Crawford N, Abbadessa G, Perez R, Wu M, Borad M. 990O Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors. Annals Of Oncology 2024, 35: s675. DOI: 10.1016/j.annonc.2024.08.1049.
- Dowlati A, Richardson D, Lorusso P, Spira A, Bashir B, Hirmand M, Mehta M, Patel M. 439TiP AVZO-021-1001: A first-in-human open-label, multicenter phase I/II dose-escalation and expansion study evaluating AVZO-021 in adult patients with advanced solid tumors. Annals Of Oncology 2024, 35: s405. DOI: 10.1016/j.annonc.2024.08.386.
- Schram A, Lopes G, El-Khoueiry A, Fontana E, Karasic T, Kummar S, Lorusso P, Gregorc V, Millward M, Aix S, Richardson D, Perez D, Spira A, Tan D, Thompson J, Uprety D, Fellous M, Qin Y, Dumbrava E. 691TiP PYNNACLE phase II trial of rezatapopt (PC14586) in solid tumors with a TP53 Y220C mutation. Annals Of Oncology 2024, 35: s535-s536. DOI: 10.1016/j.annonc.2024.08.2162.
- Choi Y, Dharia N, Jun T, Chang J, Royer-Joo S, Yau K, Assaf Z, Aimi J, Sivakumar S, Montesion M, Sacher A, LoRusso P, Desai J, Schutzman J, Shi Z, group A. Circulating Tumor DNA Dynamics Reveal KRAS G12C Mutation Heterogeneity and Response to Treatment with the KRAS G12C Inhibitor Divarasib in Solid Tumors. Clinical Cancer Research 2024, 30: of1-of10. PMID: 38995268, PMCID: PMC11369623, DOI: 10.1158/1078-0432.ccr-24-0255.
- Maldonado E, Rathmell W, Shapiro G, Takebe N, Rodon J, Mahalingam D, Trikalinos N, Kalebasty A, Parikh M, Boerner S, Balido C, Krings G, Burns T, Bergsland E, Munster P, Ashworth A, LoRusso P, Aggarwal R. A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170). Cancer Research Communications 2024, 4: 1793-1801. PMID: 38920407, PMCID: PMC11264598, DOI: 10.1158/2767-9764.crc-24-0213.
- Mukohara T, Park Y, Sommerhalder D, Yonemori K, Hamilton E, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Mita M, Clay T, Chae Y, Oakman C, Yan F, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Saul M, Le Corre C, Skoura A, Liu L, Li M, LoRusso P. Author Correction: Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial. Nature Medicine 2024, 30: 2371-2371. PMID: 38914862, PMCID: PMC11333270, DOI: 10.1038/s41591-024-03129-w.
- Ascione L, Guidi L, Prakash A, Trapani D, LoRusso P, Lou E, Curigliano G. Unlocking the Potential: Biomarkers of Response to Antibody-Drug Conjugates. American Society Of Clinical Oncology Educational Book 2024, 44: e431766. PMID: 38828973, DOI: 10.1200/edbk_431766.
- Falchook G, LoRusso P, Goldman J, El-Khoueiry A, Tolcher A, Xing Y, Henry J, Keam B, Kim D, Kim T, Kim H, Hong M, Kim M, Lee D, Lee S, Jeon J, Hayslip J, Xu C, Garon E. Phase 1 trial safety and efficacy of ragistomig, a bispecific antibody targeting PD-L1 and 4-1BB, in advanced solid tumors. Journal Of Clinical Oncology 2024, 42: 2529-2529. DOI: 10.1200/jco.2024.42.16_suppl.2529.
- Yap T, Lakhani N, Patnaik A, Lee E, Gutierrez M, Moore K, Carneiro B, Hays J, Huang M, LoRusso P, Wylie A, Cadzow L, Goulet M, Tobin E, Krieter O, Schmid D, Blake S, Dieterich M, Jamois C, Harris P. First-in-human phase I trial of the oral first-in-class ubiquitin specific peptidase 1 (USP1) inhibitor KSQ-4279 (KSQi), given as single agent (SA) and in combination with olaparib (OLA) or carboplatin (CARBO) in patients (pts) with advanced solid tumors, enriched for deleterious homologous recombination repair (HRR) mutations. Journal Of Clinical Oncology 2024, 42: 3005-3005. DOI: 10.1200/jco.2024.42.16_suppl.3005.
- Stockton S, Shyr C, Cecchini M, Aljumaily R, Halfdanarson T, Sonbol M, Whisenant J, Ivy S, LoRusso P, Das S, Gore S, Berlin J, Beumer J, Heumann T. A phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation. Journal Of Clinical Oncology 2024, 42: 3076-3076. DOI: 10.1200/jco.2024.42.16_suppl.3076.
- Heumann T, Stockton S, Cecchini M, Aljumaily R, Shyr C, Whisenant J, Starr J, Dayyani F, Baranda J, Trikalinos N, Ivy S, LoRusso P, Das S, Gore S, Beumer J, Berlin J. A phase I study of irinotecan combined with BAY1895344 (ATR inhibitor) in advanced solid tumors: Results of ETCTN 10402 dose escalation. Journal Of Clinical Oncology 2024, 42: 3077-3077. DOI: 10.1200/jco.2024.42.16_suppl.3077.
- Peltzer A, LoRusso P, Gounder M, Yamamoto N, Somaiah N, Lugowska I, Moreno V, Teufel M, Jayadeva G, Hesse R, Sturm G, Schöffski P. Treatment of patients with dedifferentiated liposarcoma (DDLPS) with the MDM2–p53 antagonist brigimadlin and p53 function: A longitudinal analysis of circulating microRNAs (miRNAs) in a first-in-human phase Ia/Ib study. Journal Of Clinical Oncology 2024, 42: 11540-11540. DOI: 10.1200/jco.2024.42.16_suppl.11540.
- Mukohara T, Park Y, Sommerhalder D, Yonemori K, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Homji Mishra N, Maity A, Bogg O, Liu L, Li M, LoRusso P. A phase 1 dose expansion study of a first-in-class KAT6 inhibitor (PF-07248144) in patients with advanced or metastatic ER+ HER2− breast cancer. Journal Of Clinical Oncology 2024, 42: 3006-3006. DOI: 10.1200/jco.2024.42.16_suppl.3006.
- Jaimes Y, LoRusso P, Sturm G, Gounder M, Yamamoto N, Somaiah N, Lugowska I, Moreno V, Peltzer A, Teufel M, Jayadeva G, Schöffski P. Proteomic analysis in patients with dedifferentiated liposarcoma (DDLPS) in a phase Ia/Ib study of the MDM2–p53 antagonist brigimadlin. Journal Of Clinical Oncology 2024, 42: 11541-11541. DOI: 10.1200/jco.2024.42.16_suppl.11541.
- Ulahannan S, Marron T, Park H, Kaczmar J, Stephenson R, Lakhani N, Durm G, Grewal J, El-Khoueiry A, Luke J, Beers C, Murugappan S, LoRusso P, Adkins D, Hecht J. Results from phase 1a/1b analyses of TTX-080, a first in class HLA-G antagonist, in combination with cetuximab in patients (pts) with metastatic colorectal cancer and head and neck squamous cell carcinoma. Journal Of Clinical Oncology 2024, 42: 2524-2524. DOI: 10.1200/jco.2024.42.16_suppl.2524.
- Yap T, Sharma M, Hamilton E, Lorusso P, Basu C, Delioukina M, Liu F, Neumann H, Park J, Giordano A. 184MO First-in-human phase I/IIa study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 in combination with endocrine therapy (ET) in patients (pts) with HR+/HER2− metastatic breast cancer (mBC) who progressed on prior CDK4/6 inhibitors (CDK4/6i): Safety and efficacy update. ESMO Open 2024, 9: 103206. DOI: 10.1016/j.esmoop.2024.103206.
- Reichardt P, Schöffski P, Lorusso P, Yamamoto N, Garcia V, Lugowska I, Lauer U, Somaiah N, Hu C, Landsteiner H, Jayadeva G, Gounder M. 61MO Phase Ia/Ib study of the MDM2-p53 antagonist brigimadlin (BI 907828) in advanced solid tumours: Overall safety, and efficacy in patients (pts) with well-differentiated liposarcoma (WDLPS). ESMO Open 2024, 9: 102451. DOI: 10.1016/j.esmoop.2024.102451.
- Schöffski P, Lorusso P, Yamamoto N, Reichardt P, Schwartz L, Dercle L, Zhao B, Chitalia R, Montgomery G, Hu C, Landsteiner H, Jayadeva G, Gounder M. 56O A phase Ia/Ib study of the MDM2-p53 antagonist brigimadlin (BI 907828): Safety and efficacy in patients with dedifferentiated liposarcoma. ESMO Open 2024, 9: 102446. DOI: 10.1016/j.esmoop.2024.102446.
- Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.
- Hu Y, Narayan A, Xu Y, Wolfe J, Vu D, Trinh T, Kantak C, Ivy S, Eder J, Deng Y, LoRusso P, Kim J, Patel A. Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors. JCO Precision Oncology 2024, 8: e2300289. PMID: 38412387, PMCID: PMC10914240, DOI: 10.1200/po.23.00289.
- Roussos Torres E, Ho W, Danilova L, Tandurella J, Leatherman J, Rafie C, Wang C, Brufsky A, LoRusso P, Chung V, Yuan Y, Downs M, O’Connor A, Shin S, Hernandez A, Engle E, Piekarz R, Streicher H, Talebi Z, Rudek M, Zhu Q, Anders R, Cimino-Mathews A, Fertig E, Jaffee E, Stearns V, Connolly R. Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial. Nature Cancer 2024, 5: 866-879. PMID: 38355777, DOI: 10.1038/s43018-024-00729-w.
- Macarulla T, Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of brigimadlin (BI 907828), an MDM2–p53 antagonist, in patients (pts) with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2024, 42: 487-487. DOI: 10.1200/jco.2024.42.3_suppl.487.
- Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.
- Lewis G, Li G, Guo J, Yu S, Fields C, Lee G, Zhang D, Dragovich P, Pillow T, Wei B, Sadowsky J, Leipold D, Wilson T, Kamath A, Mamounas M, Lee M, Saad O, Choeurng V, Ungewickell A, Monemi S, Crocker L, Kalinsky K, Modi S, Jung K, Hamilton E, LoRusso P, Krop I, Schutten M, Commerford R, Sliwkowski M, Cho E. The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results. Nature Communications 2024, 15: 466. PMID: 38212321, PMCID: PMC10784567, DOI: 10.1038/s41467-023-44533-z.
- Cecchini M, Cleary J, Shyr Y, Chao J, Uboha N, Cho M, Shields A, Pant S, Goff L, Spencer K, Kim E, Stein S, Kortmansky J, Canosa S, Sklar J, Swisher E, Radke M, Ivy P, Boerner S, Durecki D, Hsu C, LoRusso P, Lacy J. NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma. British Journal Of Cancer 2023, 130: 476-482. PMID: 38135713, PMCID: PMC10844282, DOI: 10.1038/s41416-023-02534-1.
- Desai J, Alonso G, Kim S, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller W, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim T, Moreno V, Ou S, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel M, Choi Y, Shi Z, Mandlekar S, Lin M, Royer-Joo S, Chang J, Jun T, Dharia N, Schutzman J, Han S. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nature Medicine 2023, 30: 271-278. PMID: 38052910, PMCID: PMC10803265, DOI: 10.1038/s41591-023-02696-8.
- Perets R, Stemmer S, Geva R, Golan T, Fakih M, Cohen J, Lieu C, Jin Z, Lorusso P, Ashtamker N, Friedman I, Hakim M, Crawford N, Perez R, Agarwal M, Abbadessa G, Wu M, Lin J, Deantonio C, Borad M. 161TiP A phase I/II, open-label study of an anti-ILT2 (LILRB1) antibody, SAR444881, administered alone and in combination with pembrolizumab, with or without chemotherapy, or cetuximab in patients with advanced solid tumors. Immuno-Oncology Technology 2023, 20: 100672. DOI: 10.1016/j.iotech.2023.100672.
- Yeku O, Barve M, Tan W, Wang J, Patnaik A, Lorusso P, Naqash A, Dowlati A, Fu S, Gordon M, Hubbard J, Kummar S, Kyriakopoulos C, Schenk E, Deegan D, Liang L, Li Y, Reyno L, Chamberlain M, Winer I. 126P Evaluation of myeloid targeting agents, PY159 and PY314, in two dose expansion phase Ib trials in platinum-resistant ovarian cancer. Immuno-Oncology Technology 2023, 20: 100598. DOI: 10.1016/j.iotech.2023.100598.
- Chen C, Hamilton E, LoRusso P, Rottey S, Papadopoulos K, Kummar S, Kotecki N, Thistlethwaite F, LeBruchec Y, Dyczkowski J, Rüschoff J, Samari S, Toukam M, Boni J, Havenith K, Pantano S, Puzanov I. 608 Results of a phase 1 study investigating camidanlumab tesirine as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors. 2023, a692-a692. DOI: 10.1136/jitc-2023-sitc2023.0608.
- Kim T, Bedard P, LoRusso P, Gordon M, Bendell J, Oh D, Ahn M, Garralda E, D’Angelo S, Desai J, Hodi F, Wainberg Z, Delord J, Cassier P, Cervantes A, Gil-Martin M, Wu B, Patil N, Jin Y, Hoang T, Mendus D, Wen X, Meng R, Cho B. Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors. JAMA Oncology 2023, 9: 1574-1582. PMID: 37768658, PMCID: PMC10540058, DOI: 10.1001/jamaoncol.2023.3867.
- Shimizu T, Yonemori K, Kuboki Y, Tolcher A, Kurokawa M, Munasinghe W, Phillips A, Souers A, Johnson E, He L, Weitzman A, Powderly J, Lorusso P, Naito Y. MO38-1 Phase 1 study of ABBV-155 ± paclitaxel in relapsed/refractory solid tumors: Results in Japanese patients. Annals Of Oncology 2023, 34: s1420. DOI: 10.1016/j.annonc.2023.09.250.
- Rodon J, Chaney M, Cohen J, Garyantes T, Ishizuka J, Lin J, Lorusso P, Mita A, Mita M, Muller C, Natale C, Orloff M, Papadopoulos K, Patel S, Shoushtari A. 1101P The effect of LNS8801 in combination with pembrolizumab in patients with treatment-refractory cutaneous melanoma. Annals Of Oncology 2023, 34: s663. DOI: 10.1016/j.annonc.2023.09.2235.
- Schoeffski P, Lorusso P, Yamamoto N, Lugowska I, Garcia V, Lauer U, Hu C, Jayadeva G, Lahmar M, Gounder M. 673P A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist brigimadlin (BI 907828) in patients (pts) with solid tumours. Annals Of Oncology 2023, 34: s472-s473. DOI: 10.1016/j.annonc.2023.09.1859.
- Dagogo-Jack I, Dowlati A, Guo R, Awad M, Swalduz A, Calvo E, Garcia V, Adjei A, Lorusso P, Punekar S, Leal T, Yap T, Italiano A, Novotny W, Tankersley C, Rowe S, Paris G, Sun W, Spira A, Besse B. 713TiP A phase I study of PRT3789, a potent and selective degrader of SMARCA2 in patients with advanced or metastatic solid tumors and a SMARCA4 mutation. Annals Of Oncology 2023, 34: s493-s494. DOI: 10.1016/j.annonc.2023.09.1899.
- Olszanski A, Luke J, LoRusso P, Falchook G, Bedard P, Sanborn R, Patel S, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Perera S, Xu R, Joshi A, Lee M, Raizer J, Gao X. 1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE). Annals Of Oncology 2023, 34: s625-s626. DOI: 10.1016/j.annonc.2023.09.2168.
- Sacher A, LoRusso P, Patel M, Miller W, Garralda E, Forster M, Santoro A, Falcon A, Kim T, Paz-Ares L, Bowyer S, de Miguel M, Han S, Krebs M, Lee J, Cheng M, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin M, Royer-Joo S, Chang J, Dharia N, Schutzman J, Desai J. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. New England Journal Of Medicine 2023, 389: 710-721. PMID: 37611121, DOI: 10.1056/nejmoa2303810.
- Doroshow D, Wei W, Mehrotra M, Sia D, Eder J, Bindra R, Houldsworth J, LoRusso P, Walther Z. Platinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal. Cancer Investigation 2023, 41: 646-655. PMID: 37505929, DOI: 10.1080/07357907.2023.2242957.
- Garralda E, Schram A, Bedard P, Schwartz G, Yuen E, McNeely S, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. The Oncologist 2023, 29: e131-e140. PMID: 37531083, PMCID: PMC10769797, DOI: 10.1093/oncolo/oyad215.
- Malarkey M, Toscano A, Bagheri M, Solomon J, Machado L, LoRusso P, Chen A, Folio L, Goncalves P. A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial. Heliyon 2023, 9: e18680. PMID: 37593628, PMCID: PMC10428039, DOI: 10.1016/j.heliyon.2023.e18680.
- Cecchini M, Zhang J, Wei W, Sklar J, Lacy J, Zhong M, Kong Y, Zhao H, DiPalermo J, Devine L, Stein S, Kortmansky J, Johung K, Bindra R, LoRusso P, Schalper K. Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer. Cancer Research Communications 2023, 3: 1132-1139. PMID: 37387791, PMCID: PMC10305782, DOI: 10.1158/2767-9764.crc-23-0045.
- Cecchini M, Walther Z, Wei W, Hafez N, Pilat M, Boerner S, Durecki D, Eder J, Schalper K, Chen A, LoRusso P. NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors. Cancer Research Communications 2023, 3: 1113-1117. PMID: 37377610, PMCID: PMC10292219, DOI: 10.1158/2767-9764.crc-22-0485.
- Amengual J, Shyr Y, Durecki D, Beumer J, Mansukhani M, Williams M, Kelleher N, Cherng H, Pro B, Schwartz G, LoRusso P, Piekarz R. ETCTN P10500: PHASE 1/EXPANSION STUDY OF TAZEMETOSTAT PLUS BELINOSTAT FOR THE TREATMENT OF RELAPSED OR REFRACTORY LYMPHOMA. Hematological Oncology 2023, 41: 833-834. DOI: 10.1002/hon.3166_ot14.
- LoRusso P, Yamamoto N, Patel M, Laurie S, Bauer T, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder M. The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study. Cancer Discovery 2023, 13: 1802-1813. PMID: 37269344, PMCID: PMC10401071, DOI: 10.1158/2159-8290.cd-23-0153.
- Sommerhalder D, Hamilton E, Mukohara T, Yonemori K, Mita M, Yamashita T, Zheng J, Liu L, Maity A, Homji Mishra N, Bogg O, Li M, LoRusso P. First-in-human phase 1 dose escalation study of the KAT6 inhibitor PF-07248144 in patients with advanced solid tumors. Journal Of Clinical Oncology 2023, 41: 1054-1054. DOI: 10.1200/jco.2023.41.16_suppl.1054.
- LoRusso P, Gounder M, Yamamoto N, Patel M, Bauer T, Geng J, Sailer R, Tang Y, Jayadeva G, Schöffski P. A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumors: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS). Journal Of Clinical Oncology 2023, 41: 11554-11554. DOI: 10.1200/jco.2023.41.16_suppl.11554.
- Winer I, Patnaik A, Barve M, Kummar S, Schenk E, LoRusso P, Yeku O, Fu S, Jahchan N, Myers M, Liang L, Deegan D, Jackson L, Li Y, Reyno L, Chamberlain M. A phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1). Journal Of Clinical Oncology 2023, 41: 2523-2523. DOI: 10.1200/jco.2023.41.16_suppl.2523.
- Peltzer A, Hesse R, Gounder M, Yamamoto N, Patel M, Laurie S, Bauer T, Teufel M, Geng J, LoRusso P. Longitudinal mutational analysis of TP53 in plasma circulating tumor DNA (ctDNA) in patients (pts) with solid tumors in a phase I study of BI 907828, an MDM2–p53 antagonist. Journal Of Clinical Oncology 2023, 41: 3036-3036. DOI: 10.1200/jco.2023.41.16_suppl.3036.
- Maldonado E, Rathmell W, Shapiro G, Rodon Ahnert J, Mahalingam D, Trikalinos N, Rezazadeh A, Adorno Febles V, Parikh M, Boerner S, Krings G, Takebe N, LoRusso P, Aggarwal R. A phase 2 study of the WEE1 inhibitor AZD1775 in SETD2-deficient advanced solid tumor malignancies. Journal Of Clinical Oncology 2023, 41: 3104-3104. DOI: 10.1200/jco.2023.41.16_suppl.3104.
- Carneiro B, Perets R, Dowlati A, LoRusso P, Yonemori K, He L, Munasinghe W, Noorani B, Johnson E, Zugazagoitia J. Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results. Journal Of Clinical Oncology 2023, 41: 3027-3027. DOI: 10.1200/jco.2023.41.16_suppl.3027.
- Yap T, Giordano A, Hamilton E, LoRusso P, Bowers M, Basu C, Billotte S, Delioukina M, Liu F, Yang J, Sharma M. First-in-human first-in-class phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC who progressed on prior CDK4/6 inhibitors and endocrine therapy. Journal Of Clinical Oncology 2023, 41: 3009-3009. DOI: 10.1200/jco.2023.41.16_suppl.3009.
- Rodriguez Rivera I, Hafez N, Tolcher A, LoRusso P, Wilks S, Tripathy D, Gara M, Pearson P, DeCillis A, Meric-Bernstam F. CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2023, 41: 3087-3087. DOI: 10.1200/jco.2023.41.16_suppl.3087.
- Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Eck S, Jiang Y, Khan A, Wu Y, Martin P, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Patel S. First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors. Cancer Immunology, Immunotherapy 2023, 72: 2443-2458. PMID: 37016126, PMCID: PMC10264501, DOI: 10.1007/s00262-023-03430-6.
- Schoeffski P, Yamamoto N, Bauer T, Patel M, Lorusso P, Lahmar M, Durland-Busbice S, Geng J, Gounder M. 42O A phase Ia/b, dose-escalation and expansion study evaluating the MDM2–p53 antagonist BI 907828 in patients with solid tumours: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS). ESMO Open 2023, 8: 101079. DOI: 10.1016/j.esmoop.2023.101079.
- Fanucci K, Pilat M, Shyr D, Shyr Y, Boerner S, Li J, Durecki D, Drappatz J, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma. Cancer Research Communications 2023, 3: 192-201. PMID: 36968138, PMCID: PMC10035510, DOI: 10.1158/2767-9764.crc-22-0436.
- Stockton S, Dan A, Cecchini M, Ajumaily R, Whisenant J, Gore S, Ivy P, LoRusso P, Berlin J, Das S. Phase Ia/Ib Study of BAY1895344 Plus Topoisomerase I Inhibitors with a Focus on Poorly Differentiated Neuroendocrine Carcinomas and Pancreatic Adenocarcinoma. Endocrine Abstracts 2023 DOI: 10.1530/endoabs.89.t1.
- Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Gounder M, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2023, 41: 543-543. DOI: 10.1200/jco.2023.41.4_suppl.543.
- Tolcher A, Park W, Wang J, Spira A, Janne P, Lee H, Gill S, LoRusso P, Herzberg B, Goldman J, Morgensztern D, Berlin J, Kasi A, Fujii H, Pelster M. Trial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations. Journal Of Clinical Oncology 2023, 41: tps764-tps764. DOI: 10.1200/jco.2023.41.4_suppl.tps764.
- Gounder M, Bauer T, Schwartz G, Weise A, LoRusso P, Kumar P, Tao B, Hong Y, Patel P, Lu Y, Lesegretain A, Tirunagaru V, Xu F, Doebele R, Hong D. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas. Journal Of Clinical Oncology 2023, 41: 1714-1724. PMID: 36669146, PMCID: PMC10022862, DOI: 10.1200/jco.22.01285.
- Budhraja K, McDonald B, Stephens M, Contente-Cuomo T, Markus H, Farooq M, Favaro P, Connor S, Byron S, Egan J, Ernst B, McDaniel T, Sekulic A, Tran N, Prados M, Borad M, Berens M, Pockaj B, LoRusso P, Bryce A, Trent J, Murtaza M. Genome-wide analysis of aberrant position and sequence of plasma DNA fragment ends in patients with cancer. Science Translational Medicine 2023, 15: eabm6863. PMID: 36630480, PMCID: PMC10080578, DOI: 10.1126/scitranslmed.abm6863.
- Bakouny Z, Labaki C, Grover P, Awosika J, Gulati S, Hsu C, Alimohamed S, Bashir B, Berg S, Bilen M, Bowles D, Castellano C, Desai A, Elkrief A, Eton O, Fecher L, Flora D, Galsky M, Gatti-Mays M, Gesenhues A, Glover M, Gopalakrishnan D, Gupta S, Halfdanarson T, Hayes-Lattin B, Hendawi M, Hsu E, Hwang C, Jandarov R, Jani C, Johnson D, Joshi M, Khan H, Khan S, Knox N, Koshkin V, Kulkarni A, Kwon D, Matar S, McKay R, Mishra S, Moria F, Nizam A, Nock N, Nonato T, Panasci J, Pomerantz L, Portuguese A, Provenzano D, Puc M, Rao Y, Rhodes T, Riely G, Ripp J, Rivera A, Ruiz-Garcia E, Schmidt A, Schoenfeld A, Schwartz G, Shah S, Shaya J, Subbiah S, Tachiki L, Tucker M, Valdez-Reyes M, Weissmann L, Wotman M, Wulff-Burchfield E, Xie Z, Yang Y, Thompson M, Shah D, Warner J, Shyr Y, Choueiri T, Wise-Draper T, Fromowitz A, Gandhi R, Gartrell B, Goel S, Halmos B, Makower D, O' Sullivan D, Ohri N, Portes M, Shapiro L, Shastri A, Sica R, Verma A, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Stockerl-Goldstein K, Zhou A, Bitran J, Hallmeyer S, Mundt D, Pandravada S, Papaioannou P, Patel M, Streckfuss M, Tadesse E, Gatson N, Kundranda M, Lammers P, Loree J, Yu I, Bindal P, Lam B, Peters M, Piper-Vallillo A, Egan P, Farmakiotis D, Arvanitis P, Klein E, Olszewski A, Vieira K, Angevine A, Bar M, Del Prete S, Fiebach M, Gulati A, Hatton E, Houston K, Rose S, Steve Lo K, Stratton J, Weinstein P, Garcia J, Routy B, Hoyo-Ulloa I, Dawsey S, Lemmon C, Pennell N, Sharifi N, Painter C, Granada C, Hoppenot C, Li A, Bitterman D, Connors J, Demetri G, Florez (Duma) N, Freeman D, Giordano A, Morgans A, Nohria A, Saliby R, Tolaney S, Van Allen E, Xu W, Zon R, Halabi S, Zhang T, Dzimitrowicz H, Leighton J, Graber J, Grivas P, Hawley J, Loggers E, Lyman G, Lynch R, Nakasone E, Schweizer M, Vinayak S, Wagner M, Yeh A, Dansoa Y, Makary M, Manikowski J, Vadakara J, Yossef K, Beckerman J, Goyal S, Messing I, Rosenstein L, Steffes D, Alsamarai S, Clement J, Cosin J, Daher A, Dailey M, Elias R, Fein J, Hosmer W, Jayaraj A, Mather J, Menendez A, Nadkarni R, Serrano O, Yu P, Balanchivadze N, Gadgeel S, Accordino M, Bhutani D, Bodin B, Hershman D, Masson C, Alexander M, Mushtaq S, Reuben D, Bernicker E, Deeken J, Jeffords K, Shafer D, Cárdenas A, Cuervo Campos R, De-la-Rosa-Martinez D, Ramirez A, Vilar-Compte D, Gill D, Lewis M, Low C, Jones M, Mansoor A, Mashru S, Werner M, Cohen A, McWeeney S, Nemecek E, Williamson S, Peters S, Smith S, Lewis G, Zaren H, Akhtari M, Castillo D, Cortez K, Lau E, Nagaraj G, Park K, Reeves M, O'Connor T, Altman J, Gurley M, Mulcahy M, Wehbe F, Durbin E, Nelson H, Ramesh V, Sachs Z, Wilson G, Bardia A, Boland G, Gainor J, Peppercorn J, Reynolds K, Rosovsky R, Zubiri L, Bekaii-Saab T, Joyner M, Riaz I, Senefeld J, Shah S, Ayre S, Bonnen M, Mahadevan D, McKeown C, Mesa R, Ramirez A, Salazar M, Shah P, Wang C, Bouganim N, Papenburg J, Sabbah A, Tagalakis V, Vinh D, Nanchal R, Singh H, Bahadur N, Bao T, Belenkaya R, Nambiar P, O’Cearbhaill R, Papadopoulos E, Philip J, Robson M, Rosenberg J, Wilkins C, Tamimi R, Cerrone K, Dill J, Faller B, Alomar M, Chandrasekhar S, Hume E, Islam J, Ajmera A, Brouha S, Cabal A, Choi S, Hsiao A, Jiang J, Kligerman S, Park J, Razavi P, Reid E, Bhatt P, Mariano M, Thomson C, Glace M, Knoble J, Rink C, Zacks R, Blau S, Brown C, Cantrell A, Namburi S, Polimera H, Rovito M, Edwin N, Herz K, Kennecke H, Monfared A, Sautter R, Cronin T, Elshoury A, Fleissner B, Griffiths E, Hernandez-Ilizaliturri F, Jain P, Kariapper A, Levine E, Moffitt M, O'Connor T, Smith L, Wicher C, Zsiros E, Jabbour S, Misdary C, Shah M, Batist G, Cook E, Ferrario C, Lau S, Miller W, Rudski L, Santos Dutra M, Wilchesky M, Mahmood S, McNair C, Mico V, Dixon B, Kloecker G, Logan B, Mandapakala C, Cabebe E, Jha A, Khaki A, Nagpal S, Schapira L, Wu J, Whaley D, Lopes G, de Cardenas K, Russell K, Stith B, Taylor S, Klamerus J, Revankar S, Addison D, Chen J, Haynam M, Jhawar S, Karivedu V, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Abbasi S, Annis S, Balmaceda N, Greenland S, Kasi A, Rock C, Luders M, Smits M, Weiss M, Chism D, Owenby S, Ang C, Doroshow D, Metzger M, Berenberg J, Uyehara C, Fazio A, Huber K, Lashley L, Sueyoshi M, Patel K, Riess J, Borno H, Small E, Zhang S, Andermann T, Jensen C, Rubinstein S, Wood W, Ahmad S, Brownfield L, Heilman H, Kharofa J, Latif T, Marcum M, Shaikh H, Sohal D, Abidi M, Geiger C, Markham M, Russ A, Saker H, Acoba J, Choi H, Rho Y, Feldman L, Gantt G, Hoskins K, Khan M, Liu L, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Zakharia Y, Friese C, Boldt A, Gonzalez C, Su C, Su C, Yoon J, Bijjula R, Mavromatis B, Seletyn M, Wood B, Zaman Q, Kaklamani V, Beeghly A, Brown A, Charles L, Cheng A, Crispens M, Croessmann S, Davis E, Ding T, Duda S, Enriquez K, French B, Gillaspie E, Hausrath D, Hennessy C, Lewis J, Li X, Prescott L, Reid S, Saif S, Slosky D, Solorzano C, Sun T, Vega-Luna K, Wang L, Aboulafia D, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Moore J, Rice R, Cabalona W, Cyr S, Barrow McCollough B, Peddi P, Rosen L, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Lustberg M, Masters T, Stratton C. Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19. JAMA Oncology 2023, 9: 128-134. PMID: 36326731, PMCID: PMC9634600, DOI: 10.1001/jamaoncol.2022.5357.
- Papadopoulos K, Li T, Lakhani N, Powderly J, George T, Teoh D, Kilari D, Giaccone G, Sanborn R, Ghamande S, LoRusso P, Gibney G, Ma V, Yalamanchili K, Brown J, Mota N, Kadra C, Umiker B, Xiao X, Trehu E. 172P Phase I study of JTX-8064, a LILRB2 (ILT4) inhibitor, as monotherapy and combination with pimivalimab (pimi), a PD-1 inhibitor (PD-1i), in patients (pts) with advanced solid tumors. Immuno-Oncology Technology 2022, 16: 100284. DOI: 10.1016/j.iotech.2022.100284.
- LoRusso P, Freidlin B. Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials. Journal Of The National Cancer Institute 2022, 115: 122-124. PMID: 36448688, PMCID: PMC9905964, DOI: 10.1093/jnci/djac212.
- Yap T, LoRusso P, Wong D, Hu-Lieskovan S, Papadopoulos K, Holz J, Grabowska U, Gradinaru C, Leung K, Marshall S, Reader C, Russell R, Sainson R, Seal C, Shepherd C, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clinical Cancer Research 2022, 29: 888-898. PMID: 36342102, DOI: 10.1158/1078-0432.ccr-22-1449.
- Tolcher A, Roda-Perez D, He K, Moreno V, Gomez-Roca C, Machiels J, Razak A, Sahtout M, Guan X, Jaryno-Daly S, Leibman R, Blaney M, O’Brien J, Lorusso P, Powderly J, Golan T, Miller K, Bruix J. 770 Safety, efficacy, and pharmacokinetic results from a phase I first-in-human study of ABBV-151 with or without anti-PD1 mAb (budigalimab) in patients with locally advanced or metastatic solid tumors. 2022, a801-a801. DOI: 10.1136/jitc-2022-sitc2022.0770.
- Myint H, Shah S, Gutierrez M, Zsiros E, Nelson M, Zeidan S, Myrthil N, Morawski A, Barbu A, Shaik J, Zhou C, Kanellopoulou C, Copeland R, Cusumano Z, Flies D, Langermann S, Lorusso P, Odunsi K. 748 A phase 1/2, open-label, dose-escalation, safety and tolerability study of NC762 in subjects with advanced or metastatic solid tumors. 2022, a781-a781. DOI: 10.1136/jitc-2022-sitc2022.0748.
- Harrington K, Dowling E, Latek R, Schmohl M, Lorusso P. 626 Trial in progress: an intravenously administered second-generation STING agonist, BI 1703880 with a novel lead-in design in combination with ezabenlimab. 2022, a658-a658. DOI: 10.1136/jitc-2022-sitc2022.0626.
- Rodon J, Chaney M, Cohen J, Garyantes T, Lin J, Lorusso P, Mita A, Mita M, Muller C, Natale C, Orloff M, Papadopoulos K, Patel S. 759 Phase 1b study of LNS8801 in combination with pembrolizumab in patients with secondary resistance to immune checkpoint inhibitors. 2022, a791-a791. DOI: 10.1136/jitc-2022-sitc2022.0759.
- Blanter J, Werner M, Kier M, Hapanowicz O, Itani M, Ahmad M, DeMerchant M, Eder J, Galsky M, Hammad A, King P, Lachowicz M, Lucas N, Marron T, Shelton G, Wu K, Xu S, LoRusso P, Hofstatter E, Doroshow D. Financial toxicity in patients with advanced solid malignancies participating in early-phase clinical trials. Journal Of Clinical Oncology 2022, 40: 267-267. DOI: 10.1200/jco.2022.40.28_suppl.267.
- Sacher A, Patel M, Miller W, Desai J, Garralda E, Bowyer S, Kim T, De Miguel M, Falcon A, Krebs M, Lee J, Cheng M, Han S, Shacham-Shmueli E, Forster M, Jerusalem G, Massarelli E, Rodriguez L, Prenen H, Walpole I, Arbour K, Choi Y, Dharia N, Lin M, Mandlekar S, Joo S, Shi Z, Schutzman J, LoRusso P. OA03.04 Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation. Journal Of Thoracic Oncology 2022, 17: s8-s9. DOI: 10.1016/j.jtho.2022.07.023.
- Cohen J, Natale C, Lin J, Lorusso P, Mita A, Mita M, Muller C, Orloff M, Papadopoulos K, Rodon J, Garyantes T. 85P A circulating, surrogate-systemic biomarker correlates with anti-tumor benefit on LNS8801 therapy. Annals Of Oncology 2022, 33: s578-s579. DOI: 10.1016/j.annonc.2022.07.117.
- Medina J, Torres E, Leal A, Adleff V, Lumbard K, Keefer L, Carey J, Brufsky A, Lorusso P, Eder J, Chung V, Downs M, O'Connor A, Piekarz R, Streicher H, Jaffee E, Scharpf R, Stearns V, Connolly R, Velculescu V. 1669P Monitoring immune checkpoint inhibition in advanced solid tumors using genome-wide cfDNA fragmentomes. Annals Of Oncology 2022, 33: s1306-s1307. DOI: 10.1016/j.annonc.2022.07.1749.
- Desai J, Han S, Forster M, Kim T, Casal G, Shmueli E, Bowyer S, De Miguel M, Gonzalez A, Jones R, Krebs M, Miller W, Paz-Ares L, Lorusso P, Sacher A, Dharia N, Lin M, Schutzman J, Shi Z, Patel M. 362P Phase Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer (CRC) with KRAS G12C mutation. Annals Of Oncology 2022, 33: s701-s702. DOI: 10.1016/j.annonc.2022.07.500.
- Schoeffski P, Yamamoto N, Bauer T, Patel M, Gounder M, Geng J, Sailer R, Jayadeva G, Lorusso P. 452O A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumours. Annals Of Oncology 2022, 33: s743. DOI: 10.1016/j.annonc.2022.07.581.
- Patel M, Lee J, De Miguel M, Burns T, Gonzalez A, Kim T, Krebs M, Prenen H, Shmueli E, Desai J, Lorusso P, Sacher A, Choi Y, Dharia N, Lin M, Mandlekar S, Royer-Joo S, Schutzman J, Garralda E. 459MO Phase Ia study to evaluate GDC-6036 monotherapy in patients with solid tumors with a KRAS G12C mutation. Annals Of Oncology 2022, 33: s749. DOI: 10.1016/j.annonc.2022.07.588.
- Champiat S, Wermke M, Vicier C, de Bono J, Jungels C, Vey N, Kotecki N, Wetzko K, Ruhnke L, Garralda E, de Aguiar V, Lorusso P, de Gassart A, Valentin E, Brune P, Iche M, Leparquier C, Olive D, Marabelle A, Frohna P. 732MO The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trial. Annals Of Oncology 2022, 33: s877-s878. DOI: 10.1016/j.annonc.2022.07.858.
- Garralda E, Naing A, Galvao V, LoRusso P, Grell P, Cassier P, Gomez-Roca C, Korakis I, Bechard D, Jelinkova L, Adkins I, Tillmanns S, Kiemle-Kallee J, Marabelle A, Champiat S. Interim safety and efficacy results from AURELIO-03: A phase 1 dose escalation study of the IL-2/IL-15 receptor βγ superagonist SOT101 as a single agent and in combination with pembrolizumab in patients with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 2502-2502. DOI: 10.1200/jco.2022.40.16_suppl.2502.
- Falchook G, Ribas A, Davar D, Eroglu Z, Wang J, Luke J, Hamilton E, Di Pace B, Wang T, Ghosh S, Dhar A, Borgovan T, Waszak A, LoRusso P. Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER). Journal Of Clinical Oncology 2022, 40: 2504-2504. DOI: 10.1200/jco.2022.40.16_suppl.2504.
- Goel S, Ulahannan S, Olszanski A, LoRusso P, Sanborn R, Sharma S, Emens L, Reilley M, Priego V, Li S, Wang B, Dong L, Sachsenmeier K, Gibbs J, Gharavi R, Martinez A, Proscurshim I, Fram R, Gomez-Pinillos A, Rasco D. A phase 1b, multicenter, dose-escalation study of subasumstat (TAK-981) in combination with pembrolizumab in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 2506-2506. DOI: 10.1200/jco.2022.40.16_suppl.2506.
- Muller C, Chaney M, Cohen J, Garyantes T, Lin J, LoRusso P, Mita A, Mita M, Natale C, Orloff M, Papadopoulos K, Patel S, Ahnert J. Phase 1b study of the novel first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-relapsed and refractory solid malignancies and dose escalation update. Journal Of Clinical Oncology 2022, 40: 2574-2574. DOI: 10.1200/jco.2022.40.16_suppl.2574.
- Gounder M, Yamamoto N, Patel M, Bauer T, Schöffski P, Grempler R, Durland-Busbice S, Geng J, Maerten A, LoRusso P. A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients with solid tumors, including advanced/metastatic liposarcoma (LPS). Journal Of Clinical Oncology 2022, 40: 3004-3004. DOI: 10.1200/jco.2022.40.16_suppl.3004.
- Villaruz L, Kelly K, Waqar S, Davis E, Shapiro G, LoRusso P, Dees E, Normolle D, Rhee J, Chu E, Gore S, Beumer J. NCI 9938: Phase I clinical trial of ATR inhibitor berzosertib (M6620, VX-970) in combination with irinotecan in patients with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 3012-3012. DOI: 10.1200/jco.2022.40.16_suppl.3012.
- LoRusso P, Rasco D, Shapiro G, Mita A, Azad N, Swiecicki P, El-Khoueiry A, Gandara D, Kummar S, Tanajian H, Taylor J, Bottone F, Toguchi M, Hindley C, Chan D, Oganesian A, Keer H, Dao K, Sullivan R, Spira A. A first-in-human, phase 1 study of ASTX029, a dual-mechanism inhibitor of ERK1/2, in relapsed/refractory solid tumors. Journal Of Clinical Oncology 2022, 40: 9085-9085. DOI: 10.1200/jco.2022.40.16_suppl.9085.
- Lakhani N, Friedman C, Perez C, Wehr A, McGoldrick S, LoRusso P. Phase 1 study of SGN-ALPV, a novel, investigational vedotin antibody–drug conjugate directed to ALPP/ALPPL2 in advanced solid tumors (SGNALPV-001, trial in progress). Journal Of Clinical Oncology 2022, 40: tps3159-tps3159. DOI: 10.1200/jco.2022.40.16_suppl.tps3159.
- Fanucci K, Pilat M, Shah R, Boerner S, Li J, Durecki D, Drappatz J, Collichio F, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Bao X, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma. Journal Of Clinical Oncology 2022, 40: 2035-2035. DOI: 10.1200/jco.2022.40.16_suppl.2035.
- Yap TA, Gainor JF, Callahan MK, Falchook GS, Pachynski RK, LoRusso P, Kummar S, Gibney GT, Burris HA, Tykodi SS, Rahma OE, Seiwert TY, Papadopoulos KP, Murphy M, Park H, Hanson A, Hashambhoy-Ramsay Y, McGrath L, Hooper E, Xiao X, Cohen H, Fan M, Felitsky D, Hart C, McComb R, Brown K, Sepahi A, Jimenez J, Zhang W, Baeck J, Laken H, Murray R, Trehu E, Harvey CJ. First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response. Clinical Cancer Research 2022, 28: 3695-3708. PMID: 35511938, PMCID: PMC9433959, DOI: 10.1158/1078-0432.ccr-21-4256.
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- Kuplast-Barr K, Kuplast-Barr K, Johnson M, Patel M, Yap T, Falchook G, LoRusso P, Abo R, Liu C, Manyak E, Cleary L, Bozon V, Parasuraman S, Keilhack H, McEachern K. 866 RBN-2397, a novel, potent, and selective PARP7 inhibitor, induces tumor-intrinsic type I interferon responses and adaptive immunity in preclinical models and patient tumors. Journal For ImmunoTherapy Of Cancer 2021, 9: a907-a907. DOI: 10.1136/jitc-2021-sitc2021.866.
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- Johnson M, Lopez J, LoRusso P, Bauman J, Haggstrom D, Lagkadinou E, Bajaj G, Türeci Ö, Adams H, Şahin U, Fu Y, Ahmadi T, Rohrberg K. 493 First-in-human phase 1/2 trial to evaluate the safety and initial clinical activity of DuoBody®-CD40×4–1BB (GEN1042) in patients with advanced solid tumors. Journal For ImmunoTherapy Of Cancer 2021, 9: a525-a525. DOI: 10.1136/jitc-2021-sitc2021.493.
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- Wermke M, Marabelle A, Jungels C, Bono J, Vey N, Vicier C, Garralda E, Gouill S, LoRusso P, Champiat S, List C, Aguiar V, Wetzko K, Rhunke L, Gassart A, Brune P, Valentin E, Iche M, Olive D, Frohna P. 503 Clinical activity of ICT01, an anti-BTN3A-targeted, γ9δ2-activating mAb, alone and in combination with pembrolizumab in patients with advanced/refractory solid tumors: EVICTION trial. 2021, a535-a535. DOI: 10.1136/jitc-2021-sitc2021.503.
- Patel M, Jimeno A, Wang D, Stemmer S, Bauer T, Sweis R, Geva R, Kummar S, Reagan P, Perets R, LoRusso P, Gupta S, Zacharek S, Laino A, Milberg O, Frederick J, Chen S, Pascarella S, Randolph W, Aanur P, Johansen L, Do K, Meehan R, Sullivan R. 539 Phase 1 study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L/IL-23/IL-36γ, for intratumoral (ITu) injection +/- durvalumab in advanced solid tumors and lymphoma. 2021, a569-a569. DOI: 10.1136/jitc-2021-sitc2021.539.
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- Chung H, Lee K, Kim W, Gainor J, Lakhani N, Chow L, Messersmith W, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, LoRusso P. SO-31 ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with second-line HER2-positive advanced gastric or gastroesophageal junction cancer. Annals Of Oncology 2021, 32: s215-s216. DOI: 10.1016/j.annonc.2021.05.055.
- Melero I, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso P, Tureci O, Niewood M, Sahin U, Jure-Kunkel M, Forssmann U, Ahmadi T, Alonso G. MO24-1 Phase I/IIa trial evaluating safety and clinical activity of DuoBody®-PD-L1×4-1BB (GEN1046) in advanced solid tumors. Annals Of Oncology 2021, 32: s313. DOI: 10.1016/j.annonc.2021.05.625.
- Thompson M, Henderson J, Shah P, Rubinstein S, Joyner M, Choueiri T, Flora D, Griffiths E, Gulati A, Hwang C, Koshkin V, Papadopoulos E, Robilotti E, Su C, Wulff-Burchfield E, Xie Z, Yu P, Mishra S, Senefeld J, Shah D, Warner J, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Monahan R, Zhou A, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Revankar S, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Angevine A, Bar M, Lo K, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Nizam A, Lemmon C, Hoppenot C, Li A, Bakouny Z, Bouchard G, Busser F, Conners J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Schmidt A, Shaw G, Van Allen E, Nuzzo P, Xu W, Zon R, Zhang T, Halabi S, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Gatson N, Goyal S, Huynh-Le M, Rosenstein L, Clement J, Daher A, Dailey M, Elias R, Hsu E, Menendez A, Rathmann J, Serrano O, Jayaraj A, Gadgeel S, Hawley J, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Nagle S, Hayes-Lattin B, McWeeney S, Nemecek E, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Belenkaya R, Philip J, Riely G, Faller B, McKay R, Ajmera A, Cabal A, Shaya J, Weissmann L, Jani C, Chen J, Gatti-Mays M, Jhawar S, Lustberg M, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Karivedu V, Addison D, Joshi M, Menon H, Rovito M, Elshoury A, Jabbour S, Shah M, Bashir B, Mahmood S, McNair C, Mico V, Rivera A, Miller C, Cabebe E, Glover M, Jha A, Schapira L, Shah S, Wu J, Subbiah S, Logan B, Kloecker G, Lopes G, Russell K, Stith B, Smits M, Edwin N, Chism D, Owenby S, Doroshow D, Galsky M, Zhu H, Fu J, Fazio A, Patel K, Riess J, Kwon D, Kumar V, Islam J, Wood W, Ahmad S, Grover P, Gulati S, Kharofa J, Marcum M, Park C, Wise-Draper T, Bowles D, Geiger C, Bishnoi R, Markham M, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Khan M, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Kasi A, Fecher L, Friese C, Mavromatis B, Zaman Q, Bijjula R, Cheng A, Davis E, French B, Gillaspie E, Hausrath D, Hennessy C, Hsu C, Johnson D, Li X, Reid S, Rini B, Shyr Y, Slosky D, Solorzano C, Tucker M, Vega-Luna K, Wang L, Enriquez K, Sun T, Carducci T, Puc M, Van Loon S, Goldsmith K, Rice R, Cabalona W, Pilar C, Barrow McCollough B, Peddi P, Rosen L, Bilen M, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C. Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19. JAMA Oncology 2021, 7: 1167-1175. PMID: 34137799, PMCID: PMC8377563, DOI: 10.1001/jamaoncol.2021.1799.
- Roussos Torres ET, Rafie C, Wang C, Lim D, Brufsky A, LoRusso P, Eder JP, Chung V, Downs M, Geare M, Piekarz R, Streicher H, Anforth L, Rudek MA, Zhu Q, Besharati S, Cimino-Mathews A, Anders RA, Stearns V, Jaffee EM, Connolly RM. Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844). Clinical Cancer Research 2021, 27: clincanres.5017.2021. PMID: 34135021, PMCID: PMC8563383, DOI: 10.1158/1078-0432.ccr-20-5017.
- Halperin RF, Hegde A, Lang JD, Raupach EA, Legendre C, Liang W, LoRusso P, Sekulic A, Sosman J, Trent J, Rangasamy S, Pirrotte P, Schork N. Improved methods for RNAseq-based alternative splicing analysis. Scientific Reports 2021, 11: 10740. PMID: 34031440, PMCID: PMC8144374, DOI: 10.1038/s41598-021-89938-2.
- Puzanov I, LoRusso P, Papadopoulos K, Chen C, LeBruchec Y, He X, Cousin T, Havenith K, Boni J, Bendell J. A phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 2556-2556. DOI: 10.1200/jco.2021.39.15_suppl.2556.
- Tolcher A, Carneiro B, Dowlati A, Razak A, Chae Y, Villella J, Coppola S, Englert S, Phillips A, Souers A, Salman Z, Penugonda S, Powderly J, LoRusso P. A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results. Journal Of Clinical Oncology 2021, 39: 3015-3015. DOI: 10.1200/jco.2021.39.15_suppl.3015.
- LoRusso P, Gounder M, Patel M, Yamamoto N, Bauer T, Laurie S, Grempler R, Davenport T, Geng J, Rohrbacher M, Lahmar M. A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 3016-3016. DOI: 10.1200/jco.2021.39.15_suppl.3016.
- Muller C, Brown-Glaberman U, Chaney M, Garyantes T, LoRusso P, McQuade J, Mita A, Mita M, Natale C, Orloff M, Papadopoulos K, Sato T, Yilmaz E, Rodon J. Phase 1 trial of a novel, first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in patients with advanced or recurrent treatment-refractory solid malignancies. Journal Of Clinical Oncology 2021, 39: 3084-3084. DOI: 10.1200/jco.2021.39.15_suppl.3084.
- Schram A, Ahnert J, Patel M, Jauhari S, Sachdev J, Zhu V, LoRusso P, Nguyen D, Le X, O'Connor M, Waters N, Cook C, Witt K, Humphrey R, Janne P, Hamilton E. Safety and preliminary efficacy from the phase 1 portion of MasterKey-01: A First-in-human dose-escalation study to determine the recommended phase 2 dose (RP2D), pharmacokinetics (PK) and preliminary antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients (pts) with advanced solid malignancies. Journal Of Clinical Oncology 2021, 39: 3086-3086. DOI: 10.1200/jco.2021.39.15_suppl.3086.
- Waters N, Patel M, Schram A, Ahnert J, Jauhari S, Sachdev J, Zhu V, LoRusso P, Nguyen D, Hong D, Tarilonte L, Humphrey R, Janne P, Hamilton E, Witt K. Clinical pharmacokinetics of bdtx-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study. Journal Of Clinical Oncology 2021, 39: 3097-3097. DOI: 10.1200/jco.2021.39.15_suppl.3097.
- Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Wu K, Patel S. Safety and efficacy of the anti-CD73 monoclonal antibody (mAb) oleclumab ± durvalumab in patients (pts) with advanced colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), or EGFR-mutant non-small cell lung cancer (EGFRm NSCLC). Journal Of Clinical Oncology 2021, 39: 9047-9047. DOI: 10.1200/jco.2021.39.15_suppl.9047.
- Falchook G, Luke J, Strauss J, Gao X, LoRusso P, VOON P, Li C, Shaw M, Gregory R, Horn K, Gibbs J, Lineberry N, Stumpo K, Malek K, Olszanski A. A phase 1 dose-escalation study of intravenously (IV) administered TAK-676, a novel STING agonist, alone and in combination with pembrolizumab in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2021, 39: tps2670-tps2670. DOI: 10.1200/jco.2021.39.15_suppl.tps2670.
- Yee D, LoRusso P, Sablin M, Prat A, Stradella A, Utriainen M, Oliveira M, Yonemori K, Naito Y, Hardebeck M, Puig M, Hu J, Biyukov T, Iwata H. A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease. Journal Of Clinical Oncology 2021, 39: 1057-1057. DOI: 10.1200/jco.2021.39.15_suppl.1057.
- Kim J, Cardin DB, Vaishampayan UN, Kato S, Grossman SR, Glazer P, Shyr Y, Ivy SP, LoRusso P. Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. The Oncologist 2021, 26: e1104-e1109. PMID: 33742489, PMCID: PMC8265343, DOI: 10.1002/onco.13758.
- Shaya J, Xie W, Saraiya B, Parikh M, Folefac E, Olson A, Choudhury A, Einstein D, Heath E, Parikh R, Kunos C, Ivy S, LoRusso P, Kurzrock R, Shapiro G, McKay R. A phase I/II study of combination olaparib and radium-223 in men with metastatic castration-resistant prostate cancer with bone metastases (COMRADE): A trial in progress. Journal Of Clinical Oncology 2021, 39: tps182-tps182. DOI: 10.1200/jco.2021.39.6_suppl.tps182.
- Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.
- Yap T, Wong D, Hu-Lieskovan S, Papadopoulos K, Morrow M, Grabowska U, Gliddon D, Holz J, LoRusso P. 395 A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy. 2020, a240-a240. DOI: 10.1136/jitc-2020-sitc2020.0395.
- Marabelle A, Champiat S, Garralda E, Hernando A, Janku F, Raina A, Sachse R, Bechard D, Krasnopolskaya I, Ferrara S, LoRusso P. 807 A multicenter open-label phase I/lb study of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors. 2020, a483.1-a483. DOI: 10.1136/jitc-2020-sitc2020.0807.
- Lee K, Chung H, Kim W, Chow L, Lakhani N, Messersmith W, Bang Y, LoRusso P, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC). 2020, a245.2-a246. DOI: 10.1136/jitc-2020-sitc2020.0404.
- Garralda E, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso P, Türeci Ö, Niewood M, Şahin U, Jure-Kunkel M, Forssmann U, Ahmadi T, Melero I. 412 First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD-L1×4–1BB (GEN1046) in patients with advanced solid tumors. Journal For ImmunoTherapy Of Cancer 2020, 8: a250-a251. DOI: 10.1136/jitc-2020-sitc2020.0412.
- Abidi M, Aboulafia D, Accordino M, Acoba J, Ahluwalia M, Ahmad S, Ajmera A, Alimohamed S, Altman J, Angevine A, Bakouny Z, Bar M, Bardia A, Barnholtz-Sloan J, Barrow McCollough B, Bashir B, Batist G, Bekaii-Saab T, Berg S, Bernicker E, Bhutani D, Bilen M, Bindal P, Bishnoi R, Blau S, Bohachek P, Boland G, Bonnen M, Bouchard G, Bouganim N, Bowles D, Busser F, Butt O, Cabal A, Cabalona W, Cabebe E, Caimi P, Campian J, Carducci T, Chen J, Cheng A, Chism D, Choueiri T, Clark M, Clement J, Connors J, Cook E, Curran C, Daher A, Dailey M, Davis E, Dawsey S, Deeken J, Del Prete S, Demetri G, Desai A, Doroshow D, Durbin E, Egan P, Elias R, Elkrief A, Elms D, Elshoury A, Faller B, Farmakiotis D, Fecher L, Feldman L, Ferrario C, Fiala M, Flora D, French B, Friese C, Fu J, Gadgeel S, Gainor J, Galsky M, Gantt G, Garcia J, Gartrell B, Gatti-Mays M, Gill D, Gillaspie E, Giordano A, Glace (, Glover M, Goel S, Graber J, Griffiths E, Grivas P, Grover P, Gulati A, Gulati S, Gupta S, Gurley M, Hafez N, Halabi S, Halfdanarson T, Halmos B, Hausrath D, Hawley J, Hennessy C, Herbst R, Hershman D, Hoppenot C, Hoskins K, Hoyo-Ulloa I, Hsu E, Hsu C, Hwang C, Islam J, Jabbour S, Jani C, Jha A, Jhawar S, Johnson D, Joshi M, Kasi A, Kelleher K, Kennecke H, Khaki A, Khan H, Khan M, Kharofa J, Kloecker G, Knoble J, Kulkarni A, Kumar V, Lammers P, Leighton J, Lemmon C, Lewis M, Li A, Li X, Liu S, Lo K, Loaiza-Bonilla A, Logan B, Loggers E, de Lima Lopes G, Loree J, LoRusso P, Low C, Lustberg M, Lyman G, Lynch R, Madhavan S, Mahadevan D, Mahmood S, Mansoor A, Marcum M, Markham M, Mashru S, Masters T, Mavromatis B, McKay R, McNair C, McWeeney S, Menendez A, Menon H, Mesa R, Mico V, Miller C, Mishra S, Monahan R, Morgans A, Mulcahy M, Mundt D, Mushtaq S, Nagaraj G, Nagle S, Nakasone E, Nakayama J, Nelson H, Nemecek E, Nguyen R, Nizam A, Nohria A, Nuzzo P, Ohri N, Olszewski A, Owenby S, Painter C, Palmer J, Panagiotou O, Park C, Pasquinelli M, Patel J, Patel K, Peddi P, Pennell N, Peters S, Pilar C, Pillainayagam C, Puc M, Ramirez A, Rathmann J, Ravindranathan D, Reid S, Reuben D, Revankar S, Reynolds K, Rho Y, Rhodes T, Rice R, Riess J, Rini B, Rink C, Rosen L, Rosenstein L, Rosovsky R, Routy B, Rovito M, Rubinstein S, Saif M, Salazar M, Santos Dutra M, Schapira L, Schmidt A, Schroeder B, Schwartz G, Schwartz C, Schweizer M, Serrano O, Shafer D, Shah P, Shah D, Shah M, Shah S, Shah C, Shaw G, Shaya J, Shyr Y, Slosky D, Smits M, Solorzano C, Stauffer K, Stockerl-Goldstein K, Stover D, Stratton J, Stratton C, Streckfuss M, Subbiah S, Tachiki L, Tadesse E, Thompson M, Topaloglu U, Tucker M, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Vinayak S, Vinh D, Wagner M, Wall S, Wang L, Warner J, Wehbe F, Weinstein P, Weiss M, Weissmann L, Wildes T, Williams N, Wise-Draper T, Wood W, Wu J, Wulff-Burchfield E, Xie Z, Xu W, Yeh A, Yu I, Yu P, Zacks R, Zaman Q, Zaren H, Zhang T, Zhou A, Zhu H, Zon R, Zubiri L. A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19:CCC19 Governance, Protocol, and Quality Assurance. Cancer Cell 2020, 38: 761-766. PMID: 33176160, PMCID: PMC7598547, DOI: 10.1016/j.ccell.2020.10.022.
- Gounder M, Bauer T, Schwartz G, LoRusso P, Kumar P, Kato K, Tao B, Hong Y, Patel P, Hong D. 7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas. European Journal Of Cancer 2020, 138: s3-s4. DOI: 10.1016/s0959-8049(20)31080-7.
- Hong D, Marcelo-Lewis K, LoRusso P. Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center. 2020, 71-83. DOI: 10.1007/978-3-030-47682-3_4.
- Powderly J, Shimizu T, Lorusso P, Razak A, Miller K, Balar A, Bruix J, Michel L, Blaney M, Guan X, Lacy S, Lally S, Lambert S, Leibman R, Vosganian G, Golan T, Tolcher A. Phase I first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumours. Annals Of Oncology 2020, 31: s499. DOI: 10.1016/j.annonc.2020.08.710.
- LoRusso P, Fakih M, De Vos F, Beck J, Merchan J, Shapiro G, Lin C, Desai J, Spratlin J, Cascella T, Sandalic L, Abdelhady A, Boran A, Gasal E, Janku F, Van Cutsem E. Phase Ib study of ribociclib (R) + trametinib (T) in patients (pts) with metastatic/advanced solid tumours. Annals Of Oncology 2020, 31: s484. DOI: 10.1016/j.annonc.2020.08.675.
- Puzanov I, Havenith K, Boni J, Cruz H, Anderson K, Kopotsha T, Le Bruchec Y, Bendell J, Kummar S, Papadopoulos K, LoRusso P, Wuerthner J. First-in-human study of camidanlumab tesirine (ADCT-301, Cami), an anti-CD25 targeted therapy in patients (pts) with advanced solid tumours: Pharmacokinetics (PK) and biomarker evaluation. Annals Of Oncology 2020, 31: s710-s711. DOI: 10.1016/j.annonc.2020.08.1150.
- Carducci M, Wang D, Habermehl C, Bödding M, Rohdich F, Stinchi S, Karpenko O, Gimmi C, LoRusso P. A multicenter, open-label, dose-escalation, first-in-man study of MetAP2 inhibitor M8891 in patients with advanced solid tumours. Annals Of Oncology 2020, 31: s486. DOI: 10.1016/j.annonc.2020.08.680.
- Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Hoberman M, Mughal T, Bauer T. Updated results of a phase I study of Felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in patients with relapsed/refractory solid tumours. Annals Of Oncology 2020, 31: s485-s486. DOI: 10.1016/j.annonc.2020.08.678.
- Ahn M, Niu J, Kim D, Rasco D, Mileham K, Chung H, Vaishampayan U, Maurice-Dror C, Russo P, Golan T, Chartash E, Chen D, Healy J, Rajasagi M, Lee D. Vibostolimab, an anti-TIGIT antibody, as monotherapy and in combination with pembrolizumab in anti-PD-1/PD-L1-refractory NSCLC. Annals Of Oncology 2020, 31: s887. DOI: 10.1016/j.annonc.2020.08.1714.
- Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL, Consortium C, Abidi M, Acoba J, Agarwal N, Ahmad S, Ajmera A, Altman J, Angevine A, Azad N, Bar M, Bardia A, Barnholtz-Sloan J, Barrow B, Bashir B, Belenkaya R, Berg S, Bernicker E, Bestvina C, Bishnoi R, Boland G, Bonnen M, Bouchard G, Bowles D, Busser F, Cabal A, Caimi P, Carducci T, Casulo C, Chen J, Clement J, Chism D, Cook E, Curran C, Daher A, Dailey M, Dahiya S, Deeken J, Demetri G, DiLullo S, Duma N, Elias R, Faller B, Fecher L, Feldman L, Friese C, Fu P, Fu J, Futreal A, Gainor J, Garcia J, Gill D, Gillaspie E, Giordano A, Glace G, Grothey A, Gulati S, Gurley M, Halmos B, Herbst R, Hershman D, Hoskins K, Jain R, Jabbour S, Jha A, Johnson D, Joshi M, Kelleher K, Kharofa J, Khan H, Knoble J, Koshkin V, Kulkarni A, Lammers P, Leighton J, Lewis M, Li X, Li A, Lo K, Loaiza-Bonilla A, LoRusso P, Low C, Lustberg M, Mahadevan D, Mansoor A, Marcum M, Markham M, Marshall C, Mashru S, Matar S, McNair C, McWeeney S, Mehnert J, Menendez A, Menon H, Messmer M, Monahan R, Mushtaq S, Nagaraj G, Nagle S, Naidoo J, Nakayama J, Narayan V, Nelson H, Nemecek E, Nguyen R, Nuzzo P, Oberstein P, Olszewski A, Owenby S, Pasquinelli M, Philip J, Prabhakaran S, Puc M, Ramirez A, Rathmann J, Revankar S, Rho Y, Rhodes T, Rice R, Riely G, Riess J, Rink C, Robilotti E, Rosenstein L, Routy B, Rovito M, Saif M, Sanyal A, Schapira L, Schwartz C, Serrano O, Shah M, Shah C, Shaw G, Shergill A, Shouse G, Soares H, Solorzano C, Srivastava P, Stauffer K, Stover D, Stratton J, Stratton C, Subbiah V, Tamimi R, Tannir N, Topaloglu U, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Wall S, Weinstein P, Weiss M, Wise-Draper T, Wood W, Xu W, Yackzan S, Zacks R, Zhang T, Zimmer A, West J. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. The Lancet 2020, 395: 1907-1918. PMID: 32473681, PMCID: PMC7255743, DOI: 10.1016/s0140-6736(20)31187-9.
- Thistlethwaite F, Naing A, Gil-Martin M, LoRusso P, Randhawa M, Eskens F, Sanborn R, Uboha N, Cho D, Spira A, Bondarenko I, Plummer E, Garcia-Corbacho J, Victoria I, Lavernia J, Melero I, De Vries E, Garner W, Arkenau H, Bendell J. PROCLAIM-CX-072: Analysis of patients with advanced solid tumors receiving long-term treatment with CX-072, a PD-L1 probody therapeutic, as a single agent or in combination with ipilimumab. Journal Of Clinical Oncology 2020, 38: 3005-3005. DOI: 10.1200/jco.2020.38.15_suppl.3005.
- Chow L, Gainor J, Lakhani N, Lee K, Chung H, Lee J, LoRusso P, Bang Y, Hodi F, Santana-Davila R, Fanning P, Squifflet P, Jin F, Wan H, Kuo T, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy. Journal Of Clinical Oncology 2020, 38: 3056-3056. DOI: 10.1200/jco.2020.38.15_suppl.3056.
- Patel M, Bauer T, Jimeno A, Wang D, LoRusso P, Do K, Stemmer S, Maurice-Dror C, Geva R, Zacharek S, Laino A, Sun J, Frederick J, Zhou H, Randolph W, Cohen P, Meehan R, Sullivan R. A phase I study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L, IL-23, and IL-36γ, for intratumoral (iTu) injection alone and in combination with durvalumab. Journal Of Clinical Oncology 2020, 38: 3092-3092. DOI: 10.1200/jco.2020.38.15_suppl.3092.
- Boni V, Burris III H, Liu J, Spira A, Arkenau H, Fidler M, Rosen L, Sweis R, Uboha N, Sanborn R, O'Neil B, Harding J, LoRusso P, Weise A, Garcia-Corbacho J, Victoria I, Frye J, Li R, Stroh M, Meric-Bernstam F. CX-2009, a CD166-directed probody drug conjugate (PDC): Results from the first-in-human study in patients (Pts) with advanced cancer including breast cancer (BC). Journal Of Clinical Oncology 2020, 38: 526-526. DOI: 10.1200/jco.2020.38.15_suppl.526.
- Motwani M, Modi D, Penugonda S, Zhang C, Palma J, Cunningham A, Calvo E, de Jonge M, LoRusso P. Pharmacodynamic effects in blood and tumor tissue of eftozanermin alfa, a tumor necrosis factor-related apoptosis-inducing ligand receptor agonist. Journal Of Clinical Oncology 2020, 38: e15668-e15668. DOI: 10.1200/jco.2020.38.15_suppl.e15668.
- Powderly J, Tolcher A, LoRusso P, Blaney M, Dacosta D, Henner W, McDevitt M, Miller K, Golan T. A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors. Journal Of Clinical Oncology 2020, 38: tps3147-tps3147. DOI: 10.1200/jco.2020.38.15_suppl.tps3147.
- Powderly J, Chmielowski B, Brahmer J, Piha-Paul S, Bowyer S, LoRusso P, Catenacci D, Wu C, Barve M, Chisamore M, Nasrah N, Johnson D, Ho W. Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer. Journal Of Clinical Oncology 2020, 38: tps3163-tps3163. DOI: 10.1200/jco.2020.38.15_suppl.tps3163.
- Hamilton E, Patel M, Rodon J, Hong D, Schram A, Janne P, LoRusso P, Sachdev J, Ou S, Buck E, O'Connor M, Waters N, Witt K, Cook C. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. Journal Of Clinical Oncology 2020, 38: tps3665-tps3665. DOI: 10.1200/jco.2020.38.15_suppl.tps3665.
- Gutierrez M, Hamid O, Shum E, Wise D, Balar A, Weber J, LoRusso P, Shafi S, Rimm D, Tolcher A, Basudhar D, Dujka M, Heller K. Trial in progress: A phase I/II, open-label, dose-escalation, safety and tolerability study of NC318 in subjects with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2020, 38: tps3166-tps3166. DOI: 10.1200/jco.2020.38.15_suppl.tps3166.
- LoRusso P, Pilat M, Santa-Maria C, Connolly R, Roesch E, Afghahi A, Han H, Nanda R, Wulf G, Assad H, Park H, Dees E, Force J, Noonan A, Brufsky A, Abramson V, Haley B, Buys S, Sharon E, Schalper K. Trial in progress: A phase II open-label, randomized study of PARP inhibition (olaparib) either alone or in combination with anti-PD-L1 therapy (atezolizumab) in homologous DNA repair (HDR) deficient, locally advanced or metastatic non-HER2-positive breast cancer. Journal Of Clinical Oncology 2020, 38: tps1102-tps1102. DOI: 10.1200/jco.2020.38.15_suppl.tps1102.
- Strickler JH, LoRusso P, Salgia R, Kang YK, Yen C, Lin CC, Ansell P, Motwani M, Wong S, Yue H, Wang L, Reilly E, Afar D, Naumovski L, Ramanathan RK. Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2020, 19: 1210-1217. PMID: 32127466, DOI: 10.1158/1535-7163.mct-19-0529.
- Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clinical Cancer Research 2020, 26: 1247-1257. PMID: 31527168, PMCID: PMC7528620, DOI: 10.1158/1078-0432.ccr-18-4071.
- Varga A, Soria JC, Hollebecque A, LoRusso P, Bendell J, Huang SA, Wagle MC, Okrah K, Liu L, Murray E, Sanabria-Bohorquez SM, Tagen M, Dokainish H, Mueller L, Burris H. A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors. Clinical Cancer Research 2020, 26: 1229-1236. PMID: 31848189, DOI: 10.1158/1078-0432.ccr-19-2574.
- Yap T, Gainor J, Burris H, Kummar S, Pachynski R, Callahan M, LoRusso P, Tykodi S, Gibney G, Falchook G, Rahma O, Seiwert T, Papadopoulos K, Mier J, Hashambhoy-Ramsay Y, Felitsky D, Lee D, McGrath L, Harvey C, Hooper E. Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial. Journal Of Clinical Oncology 2020, 38: 14-14. DOI: 10.1200/jco.2020.38.5_suppl.14.
- Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clinical Cancer Research 2019, 25: 6309-6319. PMID: 31420359, DOI: 10.1158/1078-0432.ccr-19-0578.
- Hamilton E, Vidula N, Ma C, LoRusso P, Bagley R, Yu Z, Annett M, Weitzman A, Conlan M, Weise A. 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC). Annals Of Oncology 2019, 30: v123. DOI: 10.1093/annonc/mdz242.038.
- Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Shemesh S, Bauer T. 466P Interim results from trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumours. Annals Of Oncology 2019, 30: v175. DOI: 10.1093/annonc/mdz244.028.
- Calvo E, de Jonge M, Rasco D, Moreno V, Chang Y, Chiney M, Motwani M, Penugonda S, Petrich A, Ratain M, LoRusso P. 457P First-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohorts. Annals Of Oncology 2019, 30: v169-v170. DOI: 10.1093/annonc/mdz244.019.
- Wainberg Z, Sachdev J, Bauer T, Pant S, Chawla S, Marina N, Xiang H, Deng W, Schmidt M, Patnaik A, LoRusso P. 1198P FPA150 (B7-H4 antibody) phase I update in advanced solid tumours: Monotherapy and in combination with pembrolizumab. Annals Of Oncology 2019, 30: v489. DOI: 10.1093/annonc/mdz253.024.
- Jung KH, LoRusso P, Burris H, Gordon M, Bang YJ, Hellmann MD, Cervantes A, de Olza M, Marabelle A, Hodi FS, Ahn MJ, Emens LA, Barlesi F, Hamid O, Calvo E, McDermott D, Soliman H, Rhee I, Lin R, Pourmohamad T, Suchomel J, Tsuhako A, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis SL. Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 3220-3228. PMID: 30770348, PMCID: PMC7980952, DOI: 10.1158/1078-0432.ccr-18-2740.
- Naing A, Thistlethwaite F, Spira A, Garcia-Corbacho J, Randhawa M, Eskens F, O'Neil B, Lavernia J, Uboha N, Hamid O, El-Khoueiry A, Benson B, Garner W, Huels V, Arkenau H, LoRusso P. CX-072, a PD-L1 Probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072. Journal Of Clinical Oncology 2019, 37: 2513-2513. DOI: 10.1200/jco.2019.37.15_suppl.2513.
- Chow L, Gainor J, Lakhani N, Chung H, Lee K, Lee J, LoRusso P, Bang Y, Hodi F, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy. Journal Of Clinical Oncology 2019, 37: 2514-2514. DOI: 10.1200/jco.2019.37.15_suppl.2514.
- Sachdev J, Bauer T, Chawla S, Pant S, Patnaik A, Wainberg Z, Inamdar S, Marina N, Sun S, Schmidt M, Xiang H, LoRusso P. Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors. Journal Of Clinical Oncology 2019, 37: 2529-2529. DOI: 10.1200/jco.2019.37.15_suppl.2529.
- Ratain M, Doi T, De Jonge M, LoRusso P, Dunbar M, Chiney M, Motwani M, Glasgow J, Petrich A, Rasco D, Calvo E. Phase 1, first-in-human study of TRAIL receptor agonist fusion protein ABBV-621. Journal Of Clinical Oncology 2019, 37: 3013-3013. DOI: 10.1200/jco.2019.37.15_suppl.3013.
- Mobasher M, Miller R, Kwei L, Strahs D, Das V, Luciano G, Powderly J, Merchan J, Barve M, LoRusso P, Tripathi A, Luke J. A phase I/Ib multicenter study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers. Journal Of Clinical Oncology 2019, 37: tps2646-tps2646. DOI: 10.1200/jco.2019.37.15_suppl.tps2646.
- Yap T, Papadopoulos K, LoRusso P, Wong D, Hu-Lieskovan S, Holz J. A first-in-human phase I study of FS118, an anti-LAG-3/PD-L1 bispecific antibody in patients with solid tumors that have progressed on prior PD-1/PD-L1 therapy. Journal Of Clinical Oncology 2019, 37: tps2652-tps2652. DOI: 10.1200/jco.2019.37.15_suppl.tps2652.
- Chong C, Bauer T, Laurie S, Patel M, Yamamoto N, Davenport T, Geng J, Gibson N, Vallaster M, LoRusso P. A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2019, 37: tps3166-tps3166. DOI: 10.1200/jco.2019.37.15_suppl.tps3166.
- Hong DS, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci DVT, Chan E, Bekaii-Saab T, Gadgeel S, Loberg RD, Amore BM, Hwang YC, Tang R, Ngarmchamnanrith G, Kwak EL. Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 2403-2413. PMID: 30425090, PMCID: PMC6892342, DOI: 10.1158/1078-0432.ccr-18-1341.
- Lorusso P, Chawla S, Bendell J, Shields A, Shapiro G, Rajagopalan P, Cyris C, Bruns I, Mei J, Souza F, Rasco D, Eder J, Tolcher A. 422P First-in-human study of the monopolar spindle 1 (Mps1) kinase inhibitor BAY 1161909 in combination with paclitaxel in subjects with advanced malignancies. Annals Of Oncology 2018, 29: viii138. DOI: 10.1093/annonc/mdy279.410.
- Bauer T, Barve M, Chiorean E, Lorusso P, Courtney K, Qi D, Olguin A, Bullington J, Sardone M, Dunn V, Shemesh S, Chen J, Brooks C, Wang J. 428P Interim results from a phase I trial of SL-801: A novel XPO-1 inhibitor, in patients with advanced solid tumors. Annals Of Oncology 2018, 29: viii140. DOI: 10.1093/annonc/mdy279.415.
- Plummer R, Sanborn R, de Vries E, Lorusso P, Arkenau H, Uboha N, Wydmanski J, Fidler M, Boni V, Garcia-Corbacho J, Humphrey R, Will M, Autio K, El-Khoueiry A, van Oordt C, Thistlethwaite F. 436P Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors. Annals Of Oncology 2018, 29: viii143. DOI: 10.1093/annonc/mdy279.423.
- Ferrarotto R, Eckhardt G, Patnaik A, LoRusso P, Faoro L, Heymach J, Kapoun A, Xu L, Munster P. A phase I dose-escalation and dose-expansion study of brontictuzumab in subjects with selected solid tumors. Annals Of Oncology 2018, 29: 1561-1568. PMID: 29726923, DOI: 10.1093/annonc/mdy171.
- Atrafi F, Boix O, Rajagopalan P, Tolcher A, LoRusso P, Eder J, Sankhala K, Chawla S, Subbiah V, Diamond J, Gutierrez M, Mathijssen R, Mei J, Verweij J, Bruns I, Lolkema M. A randomized Bayesian phase 1 design combining an MPS-1 inhibitor with paclitaxel: A strategy to improve determination of the incremental toxicity of a novel compound over a known backbone therapy. Journal Of Clinical Oncology 2018, 36: 2537-2537. DOI: 10.1200/jco.2018.36.15_suppl.2537.
- Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Olguin A, Bullington J, Sardone M, Dunn V, Shemesh S, Chen J, Brooks C, Bauer T. Interim results from a phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2018, 36: 2560-2560. DOI: 10.1200/jco.2018.36.15_suppl.2560.
- O'Neil B, Modi D, LoRusso P, Wong S, Motwani M, Sachdev J, Wolff J, Patel S, Hu B, Szmulewitz R, Sood A, Barve M, McKee M, Piha-Paul S. Gene expression and cytokine modulation in a first in human (FIH) study of a pan BET inhibitor ABBV-075 in solid tumors. Journal Of Clinical Oncology 2018, 36: 2570-2570. DOI: 10.1200/jco.2018.36.15_suppl.2570.
- Yap T, Burris H, Kummar S, Falchook G, Pachynski R, LoRusso P, Tykodi S, Gibney G, Gainor J, Rahma O, Seiwert T, Meric-Bernstam F, Blum Murphy M, Litton J, Hooper E, Hirsch H, Harvey C, Clancy M, McClure T, Callahan M. ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers. Journal Of Clinical Oncology 2018, 36: 3000-3000. DOI: 10.1200/jco.2018.36.15_suppl.3000.
- Lakhani N, LoRusso P, Hafez N, Krishnamurthy A, O'Rourke T, Kamdar M, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma. Journal Of Clinical Oncology 2018, 36: 3068-3068. DOI: 10.1200/jco.2018.36.15_suppl.3068.
- Sanborn R, Menke C, Autio K, Arkenau H, Corbacho J, LoRusso P, Plummer E, Uboha N, Freeman M, Wydmanski J, Huels V, Zheng B, Will M, Humphrey R, Thistlethwaite F, de Vries E, El-Khoueiry A. Preliminary interim results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 Probody therapeutic (Pb-Tx) CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2018, 36: 3072-3072. DOI: 10.1200/jco.2018.36.15_suppl.3072.
- Overman M, LoRusso P, Strickler J, Patel S, Clarke S, Noonan A, Prasanna T, Amin M, Nemunaitis J, Desai J, O'Byrne K, George T, Englert J, She D, Cooper Z, Wu Y, Khan A, Kumar R, Bendell J. Safety, efficacy and pharmacodynamics (PD) of MEDI9447 (oleclumab) alone or in combination with durvalumab in advanced colorectal cancer (CRC) or pancreatic cancer (panc). Journal Of Clinical Oncology 2018, 36: 4123-4123. DOI: 10.1200/jco.2018.36.15_suppl.4123.
- Bauer T, Gounder M, Weise A, Schwartz G, Carvajal R, Kumar P, Zernovak O, Beck A, Doyle J, Mendell-Harary J, Kochan J, Chen S, LoRusso P, Tap W, Somaiah N, Hyman D, Meric-Bernstam F, Hong D. A phase 1 study of MDM2 inhibitor DS-3032b in patients with well/de-differentiated liposarcoma (WD/DD LPS), solid tumors (ST) and lymphomas (L). Journal Of Clinical Oncology 2018, 36: 11514-11514. DOI: 10.1200/jco.2018.36.15_suppl.11514.
- Piha-Paul S, Sachdev J, Barve M, LoRusso P, Szmulewitz R, Patel S, McKee M, Wolff J, Hu B, Sood A, Chen X, Wilson S, O'Neil B. Results of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors. Journal Of Clinical Oncology 2018, 36: 2510-2510. DOI: 10.1200/jco.2018.36.15_suppl.2510.
- El-Khoueiry A, Desai J, Iyer S, Gadgeel S, Ramalingam S, Horn L, LoRusso P, Bajaj G, Kollia G, Qi Z, Basak S, Fischer B, Davis M, Bedard P. A phase I study of AL101, a pan-NOTCH inhibitor, in patients (pts) with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2018, 36: 2515-2515. DOI: 10.1200/jco.2018.36.15_suppl.2515.
- Lorusso P. 32IN Can adding PI3K inhibitors to the treatment cocktail alter outcome? Annals Of Oncology 2018, 29: iii5. DOI: 10.1093/annonc/mdy046.016.
- Yee D, Prat A, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Hua H, LoRusso P. 90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: x25. DOI: 10.1093/annonc/mdx656.001.
- Prat A, Yee D, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Stucke-Straub K, Russo P. 235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: v72-v73. DOI: 10.1093/annonc/mdx364.017.
- Italiano A, Infante J, Shapiro G, Moore K, Lorusso P, Postel-Vinay S, Cousin S, Toulmonde M, Lucchesi C, Blackwood E, Mahrus S, Lu X, Tagen M, Schutzman J, Lauchle J, Soria J. 375PD Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine (gem) in patients (pts) with refractory solid tumors. Annals Of Oncology 2017, 28: v125. DOI: 10.1093/annonc/mdx367.009.
- Wang J, Nemunaitis J, Chiorean G, Lorusso P, Courtney K, Olguin A, Bullington J, Shemesh S, Chen J, Brooks C, Bauer T. 406P Ongoing phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors; Interim results. Annals Of Oncology 2017, 28: v135. DOI: 10.1093/annonc/mdx367.039.
- Schwartzberg LS, Yardley D, Elias A, Patel M, LoRusso P, Burris HA, Gucalp A, Peterson A, Blaney M, Steinberg J, Gibbons J, Traina TA. A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer. Clinical Cancer Research 2017, 23: 4046-4054. PMID: 28280092, DOI: 10.1158/1078-0432.ccr-16-2339.
- Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso P, Patel MR, Domchek SM, Balmaña J, Drew Y, Chen LM, Safra T, Montes A, Giordano H, Maloney L, Goble S, Isaacson J, Xiao J, Borrow J, Rolfe L, Shapira-Frommer R. A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors. Clinical Cancer Research 2017, 23: 4095-4106. PMID: 28264872, DOI: 10.1158/1078-0432.ccr-16-2796.
- Goff L, Azad N, Stein S, Whisenant J, Vaishampayan U, Hochster H, Connolly R, Weise A, LoRusso P, El-Rifai W, Berlin J. Phase I study combining the aurora kinase A (AURKA) inhibitor alisertib (Ali) with mFOLFOX in gastrointestinal (GI) cancer. Journal Of Clinical Oncology 2017, 35: 2593-2593. DOI: 10.1200/jco.2017.35.15_suppl.2593.
- Burris H, Gordon M, Hellmann M, LoRusso P, Emens L, Hodi F, Lieu C, Infante J, Tsai F, Eder J, Cleary J, Jelovac D, Tsuhako A, Mueller L, Lin R, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis S. A phase Ib dose escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2017, 35: 105-105. DOI: 10.1200/jco.2017.35.15_suppl.105.
- Tran B, Carvajal R, Marabelle A, Patel S, LoRusso P, Rasmussen E, Juan G, Upreti V, Ngarmchamnanrith G, Schöffski P. Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2521-2521. DOI: 10.1200/jco.2017.35.15_suppl.2521.
- Yokota T, Bendell J, LoRusso P, Tsushima T, Desai V, Kenmotsu H, Watanabe J, Ono A, Murugesan B, Silva J, Naito T, Greenberg J, Kumar P, Wang Y, Jikoh T, Shiga R, Ho A, Gounder M. A call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan. Journal Of Clinical Oncology 2017, 35: 2536-2536. DOI: 10.1200/jco.2017.35.15_suppl.2536.
- Mita M, LoRusso P, McArthur G, Kim E, Bray G, Hock N, Laille E, Aronchik I, Filvaroff E, Wu X, Bendell J. A phase Ia study of CC-90003, a selective extracellular signal-regulated kinase (ERK) inhibitor, in patients with relapsed or refractory BRAF or RAS-mutant tumors. Journal Of Clinical Oncology 2017, 35: 2577-2577. DOI: 10.1200/jco.2017.35.15_suppl.2577.
- Burris H, Callahan M, Tolcher A, Kummar S, Falchook G, Pachynski R, Tykodi S, Gibney G, Seiwert T, Gainor J, LoRusso P, Hilbert J, Apgar J, Hua F, Burke J, Lazaro M, Clancy M, Ding B, Trehu E, Yap T. Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC. Journal Of Clinical Oncology 2017, 35: 3033-3033. DOI: 10.1200/jco.2017.35.15_suppl.3033.
- Chaudhary A, Chao G, Braiteh F, Gordon M, Lee J, Lorusso P, Obasaju C, Wallin J. P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical Trials. Journal Of Thoracic Oncology 2017, 12: s928-s929. DOI: 10.1016/j.jtho.2016.11.1275.
- Li C, Agarwal P, Gibiansky E, Jin J, Dent S, Gonçalves A, Nijem I, Strasak A, Harle-Yge M, Chernyukhin N, LoRusso P, Girish S. A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function. Clinical Pharmacokinetics 2016, 56: 1069-1080. PMID: 27995530, DOI: 10.1007/s40262-016-0496-y.
- LoRusso P, Miller K, Shields A, Saito K, Yoshida K, Aoyama T, Winkler R, Benedetti F, Lenz H. 361 Phase 1 Study of first-in-class dUTPase inhibitor, TAS-114 in combination with capecitabine in patients with advanced solid tumors. European Journal Of Cancer 2016, 69: s119. DOI: 10.1016/s0959-8049(16)32953-7.
- Varga A, Soria J, Hollebecque A, LoRusso P, Vaishampayan U, Okrah K, Huang S, Murray E, Sanabria-Bohorquez S, Tagen M, Dokainish H, Mueller L, Burris H. 18 A first-in-human phase I study to evaluate the ERK1/2 inhibitor GDC-0994 in patients with advanced solid tumors. European Journal Of Cancer 2016, 69: s11. DOI: 10.1016/s0959-8049(16)32624-7.
- Nogova L, Sequist LV, Garcia J, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. Journal Of Clinical Oncology 2016, 35: 157-165. PMID: 27870574, PMCID: PMC6865065, DOI: 10.1200/jco.2016.67.2048.
- McLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development. 2016, 321-344. DOI: 10.1002/9781119060727.ch13.
- Sanai N, Li J, Boerner J, Dhruv H, Berens M, LoRusso P. ACTR-10. PHASE 0 TRIAL OF AZD1775 IN FIRST-RECURRENCE GLIOBLASTOMA PATIENTS. Neuro-Oncology 2016, 18: vi3-vi3. DOI: 10.1093/neuonc/now212.009.
- Modi S, Eder J, Lorusso P, Weekes C, Chandarlapaty S, Tolaney S, McLaughlin J, Camidge D, Chang C, Nazzal D, Chen S, Schuth E, Brunstein F, Darbonne W, Flanagan W, Ungewickell A, Shapiro G. 357O A phase I study evaluating DLYE5953A, an antibody-drug conjugate targeting the tumor-associated antigen lymphocyte antigen 6 complex locus E (Ly6E), in patients (Pts) with solid tumors. Annals Of Oncology 2016, 27: vi114. DOI: 10.1093/annonc/mdw368.01.
- Geretti E, Espelin C, Adiwijaya B, Dumont N, Coma S, Koncki Z, Garcia G, Bloom T, Rimkunas V, Reynolds J, Campbell K, Moyo V, Molnar I, Lorusso P, Miller K, Ma C, Krop I, Munster P, Wickham T. 1560P Quantitative evaluation of HER2-mediated cellular uptake of the HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 suggests potential for treating HER2-intermediate tumors. Annals Of Oncology 2016, 27: vi539. DOI: 10.1093/annonc/mdw392.41.
- Falchook G, Bauer T, LoRusso P, McLaughlin J, LaVallee T, Peck R, Eder J. Safety, pharmacokinetics (PK), pharmacodynamics (Pd), and antitumor activity in a phase 1b study evaluating anti-ErbB3 antibody KTN3379 in adults with advanced tumors alone and with targeted therapies. Journal Of Clinical Oncology 2016, 34: 2501-2501. DOI: 10.1200/jco.2016.34.15_suppl.2501.
- Calvo E, Azaro A, Dirix L, Huizing M, Senecal F, LoRusso P, Yee L, Keung C, Triantos S, Park Y, Knoblauch R, Parekh T, Demetri G, vonMehren M. Trabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007). Journal Of Clinical Oncology 2016, 34: 11064-11064. DOI: 10.1200/jco.2016.34.15_suppl.11064.
- Sanai N, Li J, Boerner J, Dhruv H, Berens M, LoRusso P. Phase 0 trial of AZD1775 in patients with first-recurrence glioblastoma. Journal Of Clinical Oncology 2016, 34: 2008-2008. DOI: 10.1200/jco.2016.34.15_suppl.2008.
- Gounder M, Bauer T, Schwartz G, Masters T, Carvajal R, Song S, Kumar P, Gajee R, Zernovak O, Rosen M, Kochan J, Chen S, Hyman D, Gokmen S, Meric-Bernstam F, LoRusso P, Somaiah N, Weise A, Hong D. A phase 1 study of the MDM2 inhibitor DS-3032b in patients (pts) with advanced solid tumors and lymphomas. Journal Of Clinical Oncology 2016, 34: 2581-2581. DOI: 10.1200/jco.2016.34.15_suppl.2581.
- Hamilton E, Patel M, Gluck W, Weise A, Pant S, Jones S, LoRusso P, Kittaneh M, Cosulich S, Harrington E, Littlewood G, Oelmann E, Burris H. A phase I study of continuous (Con) and intermittent (Int) AZD2014 plus fulvestrant (F) in patients (pts) with estrogen receptor (ER+) metastatic breast cancer (BC). Journal Of Clinical Oncology 2016, 34: 563-563. DOI: 10.1200/jco.2016.34.15_suppl.563.
- Schwartz GK, Dickson MA, LoRusso P, Sausville EA, Maekawa Y, Watanabe Y, Kashima N, Nakashima D, Akinaga S. Preclinical and first‐in‐human phase I studies of KW‐2450, an oral tyrosine kinase inhibitor with insulin‐like growth factor receptor‐1/insulin receptor selectivity. Cancer Science 2016, 107: 499-506. PMID: 26850678, PMCID: PMC4832855, DOI: 10.1111/cas.12906.
- Sewald N, Ramchandren R, LoRusso P. Clinical development of antibody–drug conjugates. 2015, 136-148. DOI: 10.4155/fseb2013.14.341.
- Curigliano G, Aftimos P, Dees E, LoRusso P, Pegram M, Awada A, Huang B, Cesari R, Jiang Y, Shaik M, Kern K, Locatelli M. Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2015, 33: 1068-1068. DOI: 10.1200/jco.2015.33.15_suppl.1068.
- Juric D, De Bono J, LoRusso P, Nemunaitis J, Heath E, Kwak E, Macarulla T, Geuna E, de Miguel Luken M, Patel C, Kuida K, Sankoh S, Zohren F, Shou Y, Tabernero J. First-in-human, phase I, dose-escalation study of selective PI3Kα isoform inhibitor MLN1117 in patients (pts) with advanced solid malignancies. Journal Of Clinical Oncology 2015, 33: 2501-2501. DOI: 10.1200/jco.2015.33.15_suppl.2501.
- Papadopoulos K, Tolcher A, Patnaik A, Rasco D, Chambers G, Beeram M, Savage R, Hall T, Schwartz B, Kazakin J, LoRusso P. Phase 1, first-in-human study of ARQ 087, an oral pan-Fibroblast Growth Factor Receptor (FGFR) inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2015, 33: 2545-2545. DOI: 10.1200/jco.2015.33.15_suppl.2545.
- Bauer T, Infante J, Eder J, LoRusso P, LaVallee T, Gedrich R, Sidor C, Falchook G. A phase 1, open-label study to evaluate the safety and pharmacokinetics of the anti ErbB3 antibody, KTN3379, alone or in combination with targeted therapies in patients with advanced tumors. Journal Of Clinical Oncology 2015, 33: 2598-2598. DOI: 10.1200/jco.2015.33.15_suppl.2598.
- Goncalves P, Soubani A, Heilbrun L, Smith D, Villegas J, LoRusso P. Pulmonary function tests (PFT) results in a phase 1 (Ph1) oncology patient (pt) population. Journal Of Clinical Oncology 2015, 33: e17759-e17759. DOI: 10.1200/jco.2015.33.15_suppl.e17759.
- Shapiro G, LoRusso P, Vaishampayan U, Kittaneh M, Hilton J, Cleary J, Velastegui K, Xuan D, Hua S, Shazer R, Borghaei H. First-in-human, dose-escalation, safety, and PK study of a novel 5T4-ADC in patients with advanced solid tumors. Journal Of Clinical Oncology 2015, 33: tps2603-tps2603. DOI: 10.1200/jco.2015.33.15_suppl.tps2603.
- Kwak E, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci D, Chan E, Bekaii-Saab T, Amore B, Hwang Y, Tang R, Ngarmchamnanrith G, Hong D. Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer. Journal Of Clinical Oncology 2015, 33: 1-1. DOI: 10.1200/jco.2015.33.3_suppl.1.
- Kang Y, LoRusso P, Salgia R, Yen C, Lin C, Ramanathan R, Kaminker P, Sokolova I, Bhathena A, Wang L, Naumovski L, Strickler J. Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC). Journal Of Clinical Oncology 2015, 33: 167-167. DOI: 10.1200/jco.2015.33.3_suppl.167.
- Wang D, Braiteh F, Lee J, Denlinger C, Shepard D, Chaudhary A, Lin Y, Gao L, Asakiewicz C, Nasroulah F, LoRusso P. Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. Journal Of Clinical Oncology 2015, 33: 691-691. DOI: 10.1200/jco.2015.33.3_suppl.691.
- Morgensztern D, LoRusso P, Boerner S, Herbst R, Eder J. 48 Phase I Trials Today. 2015, 661-676.e2. DOI: 10.1016/b978-1-4557-4066-6.00048-2.
- Altman R, Dunker A, Hunter L, Ritchie M, Murray T, Klein T, NASSER S, KURDOGLU A, IZATT T, ALDRICH J, RUSSELL M, CHRISTOFORIDES A, TEMBE W, KIEFER J, CORNEVEAUX J, BYRON S, FORMAN K, ZUCCARO C, KEATS J, LORUSSO P, CARPTEN J, TRENT J, CRAIG D. AN INTEGRATED FRAMEWORK FOR REPORTING CLINICALLY RELEVANT BIOMARKERS FROM PAIRED TUMOR/NORMAL GENOMIC AND TRANSCRIPTOMIC SEQUENCING DATA IN SUPPORT OF CLINICAL TRIALS IN PERSONALIZED MEDICINE. Biocomputing 2014, 56-67. PMID: 25592568, DOI: 10.1142/9789814644730_0007.
- Patnaik A, LoRusso P, Munster P, Tolcher A, Davis S, Heymach J, Ferraroto R, Xu L, Kapoun A, Faoro L, Lewicki J, Dupont J, Eckhardt S. 2 Safety and early evidence of activity of a first-in-human phase I study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with certain advanced solid tumors. European Journal Of Cancer 2014, 50: 7. DOI: 10.1016/s0959-8049(14)70128-5.
- LoRusso P, LaVallee T, Kimmel L, Lubeski C, Gedrich R, Sidor C. 210 A phase 1 study of KTN3379, a human anti-ErbB3 monoclonal antibody in patients with advanced cancers. European Journal Of Cancer 2014, 50: 71. DOI: 10.1016/s0959-8049(14)70336-3.
- Papadopoulos K, Tolcher A, Kittaneh M, Patniak A, Rasco D, Chambers G, Newth G, Savage R, Hall T, Schwartz B, Kazakin J, LoRusso P. 389 A phase 1, dose-escalation, first-in-human study of ARQ 087, an oral pan-FGFR inhibitor, in adult subjects with advanced solid tumors. European Journal Of Cancer 2014, 50: 125. DOI: 10.1016/s0959-8049(14)70515-5.
- Kristeleit R, Shapira-Frommer R, Burris H, Patel M, Lorusso P, Oza A, Balmaña J, Domchek S, Chen L, Montes A, Plummer R, Arkenau H, Maloney L, Dominy E, Shapiro G. 882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 Results. Annals Of Oncology 2014, 25: iv307. DOI: 10.1093/annonc/mdu338.8.
- Strickler J, LoRusso P, Yen C, Lin C, Kang Y, Kaminker P, Ansell P, Bhathena A, Wong S, Dudley M, Naumovski L, Ramanathan R. Phase 1, open-label, dose-escalation, and expansion study of ABT-700, an anti-C-met antibody, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 2507-2507. DOI: 10.1200/jco.2014.32.15_suppl.2507.
- Hong D, LoRusso P, Hamid O, Beaupre D, Janku F, Khan R, Kittaneh M, Loberg R, Amore B, Caudillo I, Hwang Y, Tang R, Ngarmchamnanrith G, Kwak E. First-in-human study of AMG 337, a highly selective oral inhibitor of MET, in adult patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 2508-2508. DOI: 10.1200/jco.2014.32.15_suppl.2508.
- Tawbi H, Chu E, Lin Y, Hyman D, Goel S, Rudek M, Dowlati A, LoRusso P, Mulkerin D, Chew H, Kiesel B, Pollice L, Appleman L, Puhalla S, Stoller R, Lee J, Ivy P, Beumer J. Early phase I study of the PARP inhibitor veliparib (ABT-888) alone or in combination with carboplatin/paclitaxel (CP) in patients with varying degrees of hepatic or renal dysfunction: A study of the NCI-Organ Dysfunction Working Group (ODG). Journal Of Clinical Oncology 2014, 32: 2572-2572. DOI: 10.1200/jco.2014.32.15_suppl.2572.
- Kristeleit R, Burris H, LoRusso P, Patel M, Asghar U, El-Khouly F, Calvert A, Infante J, Hilton J, Tolaney S, Kittaneh M, Giordano H, Borrow J, Jaw-Tsai S, Shapiro G. Phase 1/2 study of oral rucaparib: Final phase 1 results. Journal Of Clinical Oncology 2014, 32: 2573-2573. DOI: 10.1200/jco.2014.32.15_suppl.2573.
- Maitland M, Ou S, Tolcher A, LoRusso P, Bahceci E, Ball H, Park J, Yuen G, Pesco Koplowitz L, Li T. Safety, activity, and pharmacokinetics of an oral anaplastic lymphoma kinase (ALK) inhibitor, ASP3026, observed in a “fast follower” phase 1 trial design. Journal Of Clinical Oncology 2014, 32: 2624-2624. DOI: 10.1200/jco.2014.32.15_suppl.2624.
- Isakoff S, Saleh M, Lugovskoy A, Manoli S, Czibere A, LoRusso P, Arnedos M. First-in-human study of MM-141: A novel tetravalent monoclonal antibody targeting IGF-1R and ErbB3. Journal Of Clinical Oncology 2014, 32: 3068-3068. DOI: 10.1200/jco.2014.32.15_suppl.3068.
- Schwartzberg L, Yardley D, Elias A, Patel M, Gucalp A, Burris H, Peterson A, Hannah A, Blaney M, Gibbons J, Tudor I, Steinberg J, LoRusso P, Infante J, Hudis C, Traina T. Enzalutamide plus exemestane: A pilot study to assess safety, pharmacokinetics, and effects on circulating estrogens in women with advanced hormone-positive breast cancer. Journal Of Clinical Oncology 2014, 32: 545-545. DOI: 10.1200/jco.2014.32.15_suppl.545.
- Moore K, Ponte J, LoRusso P, Birrer M, Bauer T, Borghaei H, O'Malley D, Ruiz-Soto R, Lutz R, Malik L. Relationship of pharmacokinetics (PK), toxicity, and initial evidence of clinical activity with IMGN853, a folate receptor alpha (FRa) targeting antibody drug conjugate in patients (Pts) with epithelial ovarian cancer (EOC) and other FRa-positive solid tumors. Journal Of Clinical Oncology 2014, 32: 5571-5571. DOI: 10.1200/jco.2014.32.15_suppl.5571.
- Lewis K, Sekulic A, Hauschild A, Migden M, Oro A, LoRusso P, Rudin C, Dirix L, Solomon J, Hainsworth J, Williams S, Hou J, Von Hoff D. Vismodegib in the treatment of patients with metastatic basal cell carcinoma (mBCC) and distant metastases: Survival in the pivotal phase II and phase I studies. Journal Of Clinical Oncology 2014, 32: 9012-9012. DOI: 10.1200/jco.2014.32.15_suppl.9012.
- Traina T, Yardley D, Patel M, Schwartzberg L, Elias A, Gucalp A, Blaney M, Gibbons J, Hudis C, LoRusso P. 10P A Phase 1 Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide Alone or Combined with an Aromatase Inhibitor in Women with Advanced Breast Cancer. Annals Of Oncology 2014, 25: i4. DOI: 10.1093/annonc/mdu064.1.
- Hendriks B, Shields A, Siegel B, Miller K, Munster P, Ma C, Campbell K, Moyo V, Wickham T, LoRusso P. 55P PET/CT Imaging of 64CU-Labelled HER2 Liposomal Doxorubicin (64CU-MM-302) Quantifies Variability of Liposomal Drug Delivery to Diverse Tumor Lesions in HER2-Positive Breast Cancer Patients. Annals Of Oncology 2014, 25: i19. DOI: 10.1093/annonc/mdu068.1.
- Britten C, Adjei A, Millham R, Houk B, Borzillo G, Pierce K, Wainberg Z, LoRusso P. Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer. Investigational New Drugs 2014, 32: 575-575. DOI: 10.1007/s10637-014-0069-6.
- LoRusso P, Hecht J, Thai D, Hawkins M, Dong H, Tolcher A. Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 554-554. DOI: 10.1200/jco.2014.32.3_suppl.554.
- Yardley D, Krop I, LoRusso P, Robert N, Mayer M, Abidoye O, Lai C, Yoo B, Perez E. Trastuzumab emtansine (T-DM1) in previously treated HER2-positive metastatic breast cancer (MBC): Results from an expanded access study. Journal Of Clinical Oncology 2013, 31: 166-166. DOI: 10.1200/jco.2013.31.26_suppl.166.
- Jimeno A, LoRusso P, Strother R, Diamond J, Plato L, Younger A, Messersmith W, Kittaneh M, Sawyer D, Adriaens L, Liu L, Kao R, DiCioccio A, Brownstein C, Lowy I, Trail P, Chiorean E. Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2502-2502. DOI: 10.1200/jco.2013.31.15_suppl.2502.
- Amaravadi R, Senzer N, Martin L, Schilder R, LoRusso P, Papadopoulos K, Weng D, Graham M, Adjei A. A phase I study of birinapant (TL32711) combined with multiple chemotherapies evaluating tolerability and clinical activity for solid tumor patients. Journal Of Clinical Oncology 2013, 31: 2504-2504. DOI: 10.1200/jco.2013.31.15_suppl.2504.
- Fontes Jardim D, Hess K, LoRusso P, Kurzrock R, Hong D. Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients. Journal Of Clinical Oncology 2013, 31: 2509-2509. DOI: 10.1200/jco.2013.31.15_suppl.2509.
- Moore K, Bendell J, Olszanski A, Desai M, Jansen M, Scheyer R, Senaldi G, LoRusso P. Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2519-2519. DOI: 10.1200/jco.2013.31.15_suppl.2519.
- Adjei A, LoRusso P, Ribas A, Sosman J, Pavlick A, Dy G, Zhou X, Gangolli E, Walker R, Kneissl M, Faucette S, Neuwirth R, Bozon V. Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2528-2528. DOI: 10.1200/jco.2013.31.15_suppl.2528.
- Kurkjian C, LoRusso P, Sankhala K, Birrer M, Kirby M, Ladd S, Hawes S, Running K, O'Leary J, Moore K. A phase I, first-in-human study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMGN853 in patients (Pts) with epithelial ovarian cancer (EOC) and other FOLR1-positive solid tumors. Journal Of Clinical Oncology 2013, 31: 2573-2573. DOI: 10.1200/jco.2013.31.15_suppl.2573.
- Kristeleit R, Shapiro G, LoRusso P, Infante J, Flynn M, Patel M, Tolaney S, Hilton J, Calvert A, Giordano H, Isaacson J, Borrow J, Allen A, Jaw-Tsai S, Burris H. A phase I dose-escalation and PK study of continuous oral rucaparib in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2585-2585. DOI: 10.1200/jco.2013.31.15_suppl.2585.
- Patnaik A, LoRusso P, Ball H, Bahceci E, Yuen G, Papadopoulos K, Kittaneh M, Tolcher A. Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial. Journal Of Clinical Oncology 2013, 31: 2602-2602. DOI: 10.1200/jco.2013.31.15_suppl.2602.
- Senzer N, LoRusso P, Martin L, Schilder R, Amaravadi R, Papadopoulos K, Segota Z, Weng D, Graham M, Adjei A. Phase II clinical activity and tolerability of the SMAC-mimetic birinapant (TL32711) plus irinotecan in irinotecan-relapsed/refractory metastatic colorectal cancer. Journal Of Clinical Oncology 2013, 31: 3621-3621. DOI: 10.1200/jco.2013.31.15_suppl.3621.
- Goncalves P, Kummar S, Siu L, Hansen A, Savvides P, Sukari A, Chao J, Heilbrun L, Pilat M, Smith D, Casetta L, Boerner S, LoRusso P. A phase II study of suberoylanilide hydroxamic acid (SAHA) in subjects with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC). Journal Of Clinical Oncology 2013, 31: 6045-6045. DOI: 10.1200/jco.2013.31.15_suppl.6045.
- Infante J, Powderly J, Burris H, Kittaneh M, Grice J, Smothers J, Brett S, Fleming M, May R, Marshall S, Devenport M, Pillemer S, Pardoll D, Chen L, Langermann S, LoRusso P. Clinical and pharmacodynamic (PD) results of a phase I trial with AMP-224 (B7-DC Fc) that binds to the PD-1 receptor. Journal Of Clinical Oncology 2013, 31: 3044-3044. DOI: 10.1200/jco.2013.31.15_suppl.3044.
- Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma. British Journal Of Cancer 2013, 108: 826-830. PMID: 23412108, PMCID: PMC3590681, DOI: 10.1038/bjc.2013.46.
- Haluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. 609 A Phase 1 Study of MEDI-573, an Investigational Monoclonal Antibody That Targets IGF-I and IGF-II: Safety, Pharmacokinetics, and Antitumor Activity in Adults with Advanced Solid Tumors. European Journal Of Cancer 2012, 48: 187-188. DOI: 10.1016/s0959-8049(12)72406-1.
- Messersmith W, LoRusso P, Cleary J, Dasari A, Huang B, Shaik N, Cesari R, McLachlan K, Kern K, Shapiro G. 588 A First-in-patient Phase I Study of the Novel Gamma Secretase Inhibitor PF-03084014 in Patients with Advanced Solid Tumor Malignancies. European Journal Of Cancer 2012, 48: 180. DOI: 10.1016/s0959-8049(12)72385-7.
- Macaulay V, Middleton M, Protheroe A, Tolcher A, Dieras V, Sessa C, Bahleda R, Blay J, LoRusso P, Mery-Mignard D, Soria J. Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors. Annals Of Oncology 2012, 24: 784-791. PMID: 23104723, PMCID: PMC3574548, DOI: 10.1093/annonc/mds511.
- Adjei A, LoRusso P, Ribas A, Sosman J, Dy G, Chmielowski B, Lipman P, Zhou X, Gangolli E, Bozón V. 456P Multicenter, Dose-Escalation Study of the Investigational Drug Tak-733, An Oral Mek inhibitor, in Patients (PTS) with Advanced Solid Tumors: Preliminary Phase 1 Results. Annals Of Oncology 2012, 23: ix158. DOI: 10.1016/s0923-7534(20)33014-3.
- Rixe O, Puzanov I, LoRusso P, Yin J, Doroumian S, Zhi X, Olszanski A. 497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid Malignancy. Annals Of Oncology 2012, 23: ix170. DOI: 10.1016/s0923-7534(20)33059-3.
- Chiu Y, LoRusso P, Ricker J, Li X, Pradhan R, Carlson D. 507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid Tumors. Annals Of Oncology 2012, 23: ix173. DOI: 10.1016/s0923-7534(20)33069-6.
- Weiss G, Oro A, Chang A, Solomon J, LoRusso P, Hamid O, Chen D, McKenna E, Feng S, Hainsworth J. 1111PD Expanded Access Study of Advanced Bcc Patients Treated with the Hedgehog-Pathway Inhibitor Vismodegib. Annals Of Oncology 2012, 23: ix362. DOI: 10.1016/s0923-7534(20)33683-8.
- Han H, Tan A, Weiss G, Sullivan D, Strosberg J, Collins S, Moss R, Wu J, Ewesuedo R, LoRusso P. A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2534-2534. DOI: 10.1200/jco.2012.30.15_suppl.2534.
- LoRusso P, Shapiro G, Pandya S, Kwak E, Jones C, Belvin M, Musib L, de Crespigny A, McKenzie M, Gates M, Chan I, Bendell J. A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2566-2566. DOI: 10.1200/jco.2012.30.15_suppl.2566.
- Borad M, Ramanathan R, Bessudo A, LoRusso P, Shepard H, Maneval D, Jiang P, Zhu J, Frost G, Infante J. Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 2579-2579. DOI: 10.1200/jco.2012.30.15_suppl.2579.
- Fetterly G, Liu B, Senzer N, Amaravadi R, Schilder R, Martin L, LoRusso P, Papadopoulos K, Adjei A, Zagst P, McKinlay M, Weng D, Graham M. Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens. Journal Of Clinical Oncology 2012, 30: 3029-3029. DOI: 10.1200/jco.2012.30.15_suppl.3029.
- Calles A, Brana I, LoRusso P, Yee L, Puchalski T, Seetharam S, Balvers M, De Boer C, Elsayed Y, Calvo E, Tabernero J. Phase Ib study of CNTO 888 (anti-CCL 2) in combination with chemotherapies for treatment of patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 3059-3059. DOI: 10.1200/jco.2012.30.15_suppl.3059.
- Alsina M, Tabernero J, Shapiro G, Burris H, Infante J, Weiss G, Cervantes-Ruiperez A, Gounder M, Paz-Ares L, Falzone R, Hill J, Cehelsky J, Vaishnaw A, Gollob J, LoRusso P. Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy. Journal Of Clinical Oncology 2012, 30: 3062-3062. DOI: 10.1200/jco.2012.30.15_suppl.3062.
- Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Activity of insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic refractory adrenocortical carcinoma. Journal Of Clinical Oncology 2012, 30: 4639-4639. DOI: 10.1200/jco.2012.30.15_suppl.4639.
- Haluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. Safety, pharmacokinetics, and antitumor activity of MEDI-573, an investigational monoclonal antibody that targets IGF-I and IGF-II, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: tps2618-tps2618. DOI: 10.1200/jco.2012.30.15_suppl.tps2618.
- Elias A, Richer J, LoRusso P, Peterson A, Steinberg J, Mordenti J, Lopez C, Hudis C, Traina T. MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer. Journal Of Clinical Oncology 2012, 30: tps668-tps668. DOI: 10.1200/jco.2012.30.15_suppl.tps668.
- Modi S, Elias A, LoRusso P, Samant M, Guardino E, Althaus B, Krop I. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. Journal Of Clinical Oncology 2012, 30: 528-528. DOI: 10.1200/jco.2012.30.15_suppl.528.
- Munster P, Miller K, Krop I, Dhindsa N, Reynolds J, Geretti E, Niyikiza C, Nielsen U, Hendriks B, Wickham T, Moyo V, LoRusso P. A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer. Journal Of Clinical Oncology 2012, 30: tps663-tps663. DOI: 10.1200/jco.2012.30.15_suppl.tps663.
- Ogita S, LoRusso P, Li J. Oral Chemotherapeutic Agents. 2012, 1-37. DOI: 10.1002/9780470921920.edm132.
- LoRusso P, Boerner S, Evelhoch J, Evelhoch J. Reply to E.S. Wang et al. Journal Of Clinical Oncology 2012, 30: 762-763. DOI: 10.1200/jco.2011.39.6895.
- Vankayala H, LoRusso P, Vaishampayan U. C-MET as a Novel Target for the Treatment of Renal Cell Carcinoma. 2012, 213-238. DOI: 10.1007/978-1-4614-2400-0_10.
- Haluska P, Huang J, Lam B, Liang M, Huang W, LoRusso P, Menefee M, LaVallee T, Yao Y, Viner J. MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer. Journal Of Clinical Oncology 2011, 29: 271-271. DOI: 10.1200/jco.2011.29.27_suppl.271.
- Garrett C, Siu L, El-Khoueiry A, Buter J, Rocha-Lima C, Marshall J, LoRusso P, Major P, Chemidlin J, Mokliatchouk O, Velasquez L, Hayes W, Feltquate D, Syed S, Ford S, Kollia G, Galbraith S, Nuyten D. Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy. British Journal Of Cancer 2011, 105: 44-52. PMID: 21629245, PMCID: PMC3137402, DOI: 10.1038/bjc.2011.182.
- Gupta M, LoRusso P, Burris H, Wang B, Joshi A, Tong Y, Chu Y, Girish S. Pharmacokinetic and pathophysiologic covariates influencing treatment outcomes with T-DM1 in patients with HER2-positive metastatic breast cancer (MBC). Journal Of Clinical Oncology 2011, 29: 633-633. DOI: 10.1200/jco.2011.29.15_suppl.633.
- Naing A, LoRusso P, Fu S, Hong D, Anderson P, Benjamin R, Ludwig J, Chen H, Doyle L, Kurzrock R. Cixutumumab combined with temsirolimus in patients with refractory Ewing’s sarcoma. Journal Of Clinical Oncology 2011, 29: 10031-10031. DOI: 10.1200/jco.2011.29.15_suppl.10031.
- Maitah M, Ali S, LoRusso P, Sarkar F, Gadgeel S. The role of GDC-0449, a hedgehog (Hh) pathway inhibitor, on epithelial–mesenchymal transition (EMT) in non-small cell lung cancer (NSCLC) cells lines and its effect on erlotinib and cisplatin. Journal Of Clinical Oncology 2011, 29: 10537-10537. DOI: 10.1200/jco.2011.29.15_suppl.10537.
- Camidge D, Bang Y, Kwak E, Shaw A, Iafrate A, Maki R, Solomon B, Ou S, Salgia R, Wilner K, Costa D, Shapiro G, LoRusso P, Stephenson P, Tang Y, Ruffner K, Clark J. Progression-free survival (PFS) from a phase I study of crizotinib (PF-02341066) in patients with ALK- positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2011, 29: 2501-2501. DOI: 10.1200/jco.2011.29.15_suppl.2501.
- Chiorean E, Sausville E, Heath E, Weise A, Gomez-Navarro J, Venkatakrishnan K, Sankoh S, Wu J, Corvez M, LoRusso P. Phase I study of TAK-285, an investigational HER2/EGFR inhibitor, in patients (pts) with advanced cancer: Updated results and assessment of human CSF distribution. Journal Of Clinical Oncology 2011, 29: 2538-2538. DOI: 10.1200/jco.2011.29.15_suppl.2538.
- LoRusso P, Ji J, Li J, Heilbrun L, Shapiro G, Sausville E, Boerner S, Smith D, Pilat M, Zhang J, Chen A, Nechiporchik N, Parchment R. Phase I study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib (ABT-888; V) in combination with irinotecan (CPT-11; Ir) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3000-3000. DOI: 10.1200/jco.2011.29.15_suppl.3000.
- Shapiro G, LoRusso P, Kwak E, Cleary J, Musib L, Jones C, de Crespigny A, Belvin M, McKenzie M, Gates M, Chan I, Bendell J. Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human phase Ib study testing daily and intermittent dosing schedules in patients with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3005-3005. DOI: 10.1200/jco.2011.29.15_suppl.3005.
- Cervantes A, Alsina M, Tabernero J, Infante J, LoRusso P, Shapiro G, Paz-Ares L, Falzone R, Hill J, Cehelsky J, White A, Toudjarska I, Bumcrot D, Meyers R, Hinkle G, Svrzikapa N, Sah D, Vaishnaw A, Gollob J, Burris H. Phase I dose-escalation study of ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement. Journal Of Clinical Oncology 2011, 29: 3025-3025. DOI: 10.1200/jco.2011.29.15_suppl.3025.
- Berlin J, Keedy V, Janne P, Yee L, Rizvi N, Jin X, Copigneaux C, Hettmann T, Beaupre D, LoRusso P. A first-in-human phase I study of U3-1287 (AMG 888), a HER3 inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3026-3026. DOI: 10.1200/jco.2011.29.15_suppl.3026.
- Weekes C, LoRusso P, Ramakrishnan V, Shih L, Darbonne W, Hegde P, Xin Y, Yu R, Xiang H, Brachmann R, Patnaik A. A phase Ib study for MNRP1685A (anti-NRP1) administered intravenously with bevacizumab with or without paclitaxel to patients with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3050-3050. DOI: 10.1200/jco.2011.29.15_suppl.3050.
- Cho D, Heath E, Cleary J, Kwak E, Gandhi L, Lawrence D, Zack C, Teofilovici F, Bradley R, Karol M, Shapiro G, LoRusso P. A phase I dose-escalation study of the Hsp90 inhibitor ganetespib (STA-9090) administered twice weekly in patients with solid tumors: Updated report. Journal Of Clinical Oncology 2011, 29: 3051-3051. DOI: 10.1200/jco.2011.29.15_suppl.3051.
- Von Hoff D, LoRusso P, Demetri G, Weiss G, Shapiro G, Ramanathan R, Ware J, Raja R, Jin J, Levy G, Mazina K, Wagner A. A phase I dose-escalation study to evaluate GDC-0941, a pan-PI3K inhibitor, administered QD or BID in patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2011, 29: 3052-3052. DOI: 10.1200/jco.2011.29.15_suppl.3052.
- Sausville E, LoRusso P, Carducci M, Barker P, Agbo F, Oakes P, Senderowicz A. Phase I dose-escalation study of AZD7762 in combination with gemcitabine (gem) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3058-3058. DOI: 10.1200/jco.2011.29.15_suppl.3058.
- Sarantopoulos J, Lenz H, LoRusso P, Shibata S, Kummar S, Mulkerin D, Ramanathan R, Mita M, O'Rourke P, Remick S, Goel S, Gutierrez M, Ramalingam S, Murgo A, Davies A, Mani S, Boni J, Shapiro M, Ivy S, Takimoto C. Phase I pharmacokinetic study of temsirolimus (CCI-779) in patients with advanced malignancies and normal and impaired liver function: An NCI Organ Dysfunction Working Group (ODWG) study. Journal Of Clinical Oncology 2011, 29: 3072-3072. DOI: 10.1200/jco.2011.29.15_suppl.3072.
- Dickson M, LoRusso P, Sausville E, Rao N, Kobayashi E, Kurman M, Akinaga S, Schwartz G. Open-label, sequential, ascending, multi-dose, phase I study of KW-2450 as monotherapy in subjects with previously treated advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3078-3078. DOI: 10.1200/jco.2011.29.15_suppl.3078.
- Messersmith W, LoRusso P, Cleary J, Dasari A, Zhang X, Shaik M, Courtney R, Randolph S, Shapiro G. A phase I dose-escalation study of the novel gamma secretase inhibitor PF-03084014 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3100-3100. DOI: 10.1200/jco.2011.29.15_suppl.3100.
- Gadgeel S, Ruckdeschel J, Wozniak A, Chen W, Hackstock D, Galasso C, Burger A, Ivy S, LoRusso P, Edelman M. Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2011, 29: 7564-7564. DOI: 10.1200/jco.2011.29.15_suppl.7564.
- Darbonne W, Du X, Dhawan P, Hartley D, Tarrant J, Taylor H, Cain G, Shih L, Brachmann R, Phung Q, Weekes C, LoRusso P, Patnaik A, Xiang H, Ramakrishnan V. Mechanism for platelet reduction in anti-neuropilin-1 (MNRP1685A)–treated phase I patients. Journal Of Clinical Oncology 2011, 29: e13598-e13598. DOI: 10.1200/jco.2011.29.15_suppl.e13598.
- Sosman J, Adjei A, LoRusso P, Michael S, Dy G, Bowditch A, Chmielowski B, Lee S, Walker R, Faucette S, Izmailova E, Bozon V, Ribas A. First-in-human, multicenter, dose-escalation, phase I study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced nonhematologic malignancies and melanoma. Journal Of Clinical Oncology 2011, 29: tps145-tps145. DOI: 10.1200/jco.2011.29.15_suppl.tps145.
- Leal T, Remick S, Takimoto C, Ramanathan R, Davies A, Egorin M, Hamilton A, LoRusso P, Shibata S, Lenz H, Mier J, Sarantopoulos J, Mani S, Wright J, Ivy S, Neuwirth R, von Moltke L, Venkatakrishnan K, Mulkerin D. Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study. Cancer Chemotherapy And Pharmacology 2011, 68: 1439-1447. PMID: 21479634, PMCID: PMC3481841, DOI: 10.1007/s00280-011-1637-5.
- Burger A, LoRusso P. Breast Cancer Rationally Designed Therapies. 2011, 537-546. DOI: 10.1007/978-3-642-16483-5_6746.
- Venkatakrishnan K, Ramanathan R, Sarantopoulos J, Mulkerin D, Shibata S, Hamilton A, Dowlati A, Mani S, Rudek M, Ivy P, Takimoto C, Neuwirth R, Parasuraman S, LoRusso P. Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432. Blood 2010, 116: 3975. DOI: 10.1182/blood.v116.21.3975.3975.
- Shimizu T, Tolcher A, LoRusso P, Papadopoulos K, Patnaik A, Smith L, Keegan M. 364 The first-in-human, first-in-class study of CUDC-101, a multi-targeted inhibitor of HDAC, EGFR, and HER2: A Phase I study in patients with advanced cancer. European Journal Of Cancer Supplements 2010, 8: 115. DOI: 10.1016/s1359-6349(10)72071-1.
- LoRusso P. 6 Challenges in clinical development of stem-cell therapy. European Journal Of Cancer Supplements 2010, 8: 10. DOI: 10.1016/s1359-6349(10)71709-2.
- Ratain M, Kelsey S, Janisch L, Smith J, Go N, Lin T, Maitland M, Kindler H, LoRusso P. 388 Imetelstat sodium (GRN163L), a telomerase inhibitor: tolerability, pharmacokinetics and pharmacodynamic activity using an intermittent once every four weeks dosing schedule in patients with advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 123. DOI: 10.1016/s1359-6349(10)72095-4.
- Menefee M, LoRusso P, Vin J, McDevitt J, Huang W, Lam B, Jin F, Chang Y, Haluska P. 3LB MEDI-573, a dual IGF-1/-2 neutralizing antibody, blocks IGF-1R and IR-A signaling and maintains glucose homeostasis in a Phase 1 study for advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 3-4. DOI: 10.1016/s1359-6349(10)71700-6.
- Tolcher A, Papadopolous K, Patniak A, Heath E, Weise A, Prokop T, Morrone S, Zanghi J, Keer H, LoRusso P. 381 Preliminary results of a dose escalation study of the Fibroblast Growth Factor (FGF) “trap” FP-1039 (FGFR1:Fc) in patients with advanced malignancies. European Journal Of Cancer Supplements 2010, 8: 121. DOI: 10.1016/s1359-6349(10)72088-7.
- Britten C, Adjei A, Millham R, Houk B, Wainberg Z, Guthrie T, Dy G, LoRusso P. 383 First-in-human study of PF-04691502, a small molecule oral dual inhibitor of PI3K and mTOR in patients with advanced cancer: Preliminary report on safety and pharmacokinetics. European Journal Of Cancer Supplements 2010, 8: 121-122. DOI: 10.1016/s1359-6349(10)72090-5.
- Nechiporchik N, Lieb K, Marquette L, Polin L, Peters G, Chen A, Ethier S, LoRusso P, Burger A. 189 Preclinical activity of the poly (ADP-ribose) polymerase (PARP) inhibitor ABT-888 in combination with irinotecan in ovarian and triple negative breast cancers. European Journal Of Cancer Supplements 2010, 8: 64. DOI: 10.1016/s1359-6349(10)71894-2.
- LoRusso P, Keedy V, Yee L, Oliveira M, Rizvi N, Berlin J, Jin X, Hettmann T, Copigneaux C, Beaupre D. 234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 76. DOI: 10.1016/s1359-6349(10)71939-x.
- 363 Dose of the molecularly targeted agents (MTA) in Phase 1 trials correlates with clinical benefitGupta S, Alqwasmi A, Hunsberger S, Rubinstein L, Ivy P, Royds R, LoRusso P. 363 Dose of the molecularly targeted agents (MTA) in Phase 1 trials correlates with clinical benefit. European Journal Of Cancer Supplements 2010, 8: 115. DOI: 10.1016/s1359-6349(10)72070-x.
- Fairbrother W, Wong H, Budha N, Blackwood B, Gould S, Erickson R, LoRusso P, Eckhardt S, Wagner A, Chan I. 82 Pharmacokinetic–pharmacodynamic modeling of the effect of GDC-0152, a selective antagonist of the inhibitor of apoptosis (IAP) proteins, on monocyte chemotactic protein-1 (MCP-1) indicates species differences in MCP-1 response. European Journal Of Cancer Supplements 2010, 8: 34. DOI: 10.1016/s1359-6349(10)71787-0.
- Fairbrother W, LoRusso P, Wagner A, Budha N, Darbonne W, Shin Y, Wong H, Chan I, Ware J, Eckhardt S. 393 Phase I pharmacokinetics and pharmacodynamics of GDC-0152, a novel IAP protein antagonist, administered to patients with locally advanced or metastatic malignancies. European Journal Of Cancer Supplements 2010, 8: 125. DOI: 10.1016/s1359-6349(10)72100-5.
- Heath E, Chiorean E, Sweeney C, Hodge J, Lager J, Forman K, Malburg L, Arumugham T, Dar M, Suttle A, Gainer S, LoRusso P. A Phase I Study of the Pharmacokinetic and Safety Profiles of Oral Pazopanib With a High‐Fat or Low‐Fat Meal in Patients With Advanced Solid Tumors. Clinical Pharmacology & Therapeutics 2010, 88: 818-823. PMID: 20980999, DOI: 10.1038/clpt.2010.199.
- Goncalves P, Sausville E, Edelman M, Pandya N, Houlehan M, Freeman B, Simmons H, Stallings J, Ptaszynski A, LoRusso P. A phase I study of ARRY-520 in solid tumors. Journal Of Clinical Oncology 2010, 28: 2570-2570. DOI: 10.1200/jco.2010.28.15_suppl.2570.
- Patel S, Lazar A, Mahoney S, Vaughn C, Gonzalez N, Papadopoulos N, Liu P, Infante J, LoRusso P, Kim K. Clinical responses to AZD6244 (ARRY-142886)-based combination therapy stratified by gene mutations in patients with metastatic melanoma. Journal Of Clinical Oncology 2010, 28: 8501-8501. DOI: 10.1200/jco.2010.28.15_suppl.8501.
- Minton S, LoRusso P, Lockhart A, Saif M, Krishnamurthi S, Pickett-Gies C, Wang Y, Guan S, Roben E, Stein M. A phase I study of MK-5108, an oral aurora A kinase inhibitor, in both monotherapy and in combination with docetaxel in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: e13026-e13026. DOI: 10.1200/jco.2010.28.15_suppl.e13026.
- Gomez-Roca C, Baey C, Olmos D, Berens A, Bigger E, LoRusso P, Rothenberg M, Kaye S, Pignon J, Soria J. An international pooled analysis identifying predictive factors associated with toxicities in phase I trials (Delphi). Journal Of Clinical Oncology 2010, 28: 2517-2517. DOI: 10.1200/jco.2010.28.15_suppl.2517.
- Von Hoff D, LoRusso P, Tibes R, Shapiro G, Weiss G, Ware J, Fredrickson J, Mazina K, Levy G, Wagner A. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: 2541-2541. DOI: 10.1200/jco.2010.28.15_suppl.2541.
- Egorin M, Kummar S, Sarantopoulos J, Shibata S, LoRusso P, Yerk M, Lin Y, Ivy S, Belani C, Ramalingam S. Phase I study of vorinostat for patients with advanced solid tumors and hepatic dysfunction: An NCI Organ Dysfunction Working Group (ODWG) study (NCI #8057). Journal Of Clinical Oncology 2010, 28: 2545-2545. DOI: 10.1200/jco.2010.28.15_suppl.2545.
- LoRusso P, Krop I, Burris H, Vukelja S, Miller K, Zheng M, Chu Y, Lu M, Amler L, Rugo H. Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy. Journal Of Clinical Oncology 2010, 28: 1016-1016. DOI: 10.1200/jco.2010.28.15_suppl.1016.
- Busaidy N, Kurzrock R, LoRusso P, Owens A, Chen H, Doyle L, Zhang J, Lawhorn K, Chandhasin C, Naing A. Hyperglycemia, hypertriglyceridemia, and hypercholesterolemia in a phase I trial of the combination of an mTOR inhibitor and IGF-1 receptor inhibitor. Journal Of Clinical Oncology 2010, 28: 2597-2597. DOI: 10.1200/jco.2010.28.15_suppl.2597.
- Naing A, LoRusso P, Gupta S, Benjamin R, Rohren E, Chen H, Doyle L, Berry D, Amin H, Kurzrock R. Dual inhibition of IGFR and mTOR pathways. Journal Of Clinical Oncology 2010, 28: 3007-3007. DOI: 10.1200/jco.2010.28.15_suppl.3007.
- Brana I, LoRusso P, Baselga J, Heath E, Patnaik A, Gendreau S, Laird A, Papadopoulos K. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765 (SAR245409), a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced malignancies. Journal Of Clinical Oncology 2010, 28: 3030-3030. DOI: 10.1200/jco.2010.28.15_suppl.3030.
- Liu G, LoRusso P, Heath E, Bruce J, Traynor A, Pilat M, Breazna A, Tortorici M, Shalinsky D, Ricart A. Pharmacodynamically guided dose selection of PF-00337210, a VEGFR2 tyrosine kinase (TK) inhibitor, in a phase I study. Journal Of Clinical Oncology 2010, 28: 3033-3033. DOI: 10.1200/jco.2010.28.15_suppl.3033.
- Gollob J, Infante J, Shapiro G, LoRusso P, Dezube B, Heymach J, Cehelsky J, Falzone R, Vaishnaw A, Burris H. Interim safety and pharmacodynamic results for ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement. Journal Of Clinical Oncology 2010, 28: 3042-3042. DOI: 10.1200/jco.2010.28.15_suppl.3042.
- Moldovan C, Soria J, LoRusso P, Guthrie T, Song C, Nguyen L, Martini J, Infante J, Burris H. A phase I safety and pharmacokinetic (PK) study of the PI3K inhibitor XL147 (SAR245408) in combination with erlotinib in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: 3070-3070. DOI: 10.1200/jco.2010.28.15_suppl.3070.
- Sharma S, Sausville E, LoRusso P, Vogelzang N, Samlowski W, Carter J, Forman K, Bever S, Messmann R. A phase I study of EC0225 administered weeks 1 and 2 of a 4-week cycle. Journal Of Clinical Oncology 2010, 28: 3082-3082. DOI: 10.1200/jco.2010.28.15_suppl.3082.
- Cleary J, Heath E, Kwak E, Dezube B, Gandhi L, Zack C, Bradley R, Vukovic V, Shapiro G, LoRusso P. A phase I dose-escalation study of the Hsp90 inhibitor STA-9090 administered twice weekly in patients with solid tumors. Journal Of Clinical Oncology 2010, 28: 3083-3083. DOI: 10.1200/jco.2010.28.15_suppl.3083.
- Harb W, Conley B, LoRusso P, Sausville E, Heath E, Chandana S, Hamm M, Carter J, Perez W, Messmann R. A phase I study of the folate-targeted conjugate EC0489 in patients with refractory or advanced metastatic cancer. Journal Of Clinical Oncology 2010, 28: 3088-3088. DOI: 10.1200/jco.2010.28.15_suppl.3088.
- Chawla S, Tabernero J, Kindler H, Chiorean E, LoRusso P, Hsu M, Haddad V, Bach B, Baselga J. Phase I evaluation of the safety of conatumumab (AMG 655) in combination with AMG 479 in patients (pts) with advanced, refractory solid tumors. Journal Of Clinical Oncology 2010, 28: 3102-3102. DOI: 10.1200/jco.2010.28.15_suppl.3102.
- Heath E, LoRusso P, Kurzrock R, Falchook G, Maroun C, Drouin M, Juretic M, Martell R, Besterman J, Wheler J. A phase I study of oral administration of MGCD265 in patients with advanced malignancies (study 265-102). Journal Of Clinical Oncology 2010, 28: 3108-3108. DOI: 10.1200/jco.2010.28.15_suppl.3108.
- Patnaik A, Weekes C, Hegde P, Xin Y, Yu R, Xiang H, Brachmann R, LoRusso P. A phase Ib study to evaluate the fully human monoclonal antibody MNRP1685A (anti-NRP1) administered intravenously in combination with bevacizumab with or without weekly paclitaxel in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: tps180-tps180. DOI: 10.1200/jco.2010.28.15_suppl.tps180.
- LoRusso P, Girish S, Burris H, Beeram M, Vukelja S, Modi S, Yi J, Wang B, Saad O, Gupta M. Population Pharmacokinetics of Trastuzumab-DM1, a First-in-Class HER2 Antibody-Drug Conjugate Given Every 3 Weeks (q3w) and Weekly (qw) to Patients with HER2-Positive Metastatic Breast Cancer (MBC). Cancer Research 2009, 69: 5099-5099. DOI: 10.1158/0008-5472.sabcs-09-5099.
- Krop I, LoRusso P, Miller K, Modi S, Yardley D, Rodriguez G, Agresta S, Zheng M, Amler L, Rugo H. A Phase II Study of Trastuzumab-DM1 (T-DM1), a Novel HER2 Antibody–Drug Conjugate, in HER2+ Metastatic Breast Cancer (MBC) Patients Previously Treated with Conventional Chemotherapy, Lapatinib and Trastuzumab. Cancer Research 2009, 69: 5090-5090. DOI: 10.1158/0008-5472.sabcs-09-5090.
- Demetri G, Russo P, MacPherson I, Wang D, Morgan J, Brunton V, Paliwal P, Agrawal S, Voi M, Evans T. Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors. Clinical Cancer Research 2009, 15: 6232-6240. PMID: 19789325, DOI: 10.1158/1078-0432.ccr-09-0224.
- LoRusso P, Zalupski M, Desai S, Burris H, Stella P, Xu J, Liu Q, Mookerjee B, Shields A. 1242 Cediranib in combination with mFOLFOX6: results from the cohort expansion phase of a two-part Phase I study. European Journal Of Cancer Supplements 2009, 7: 133. DOI: 10.1016/s1359-6349(09)70454-9.
- Von Hoff D, Wagner A, LoRusso P, Tibes R, Jin J, Ware J, Yan Y, Derynck M, Dolezal M, Demetri G. 1205 A first-in-human Phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumours. European Journal Of Cancer Supplements 2009, 7: 122. DOI: 10.1016/s1359-6349(09)70417-3.
- Vonderheide R, LoRusso P, Khalil M, Heath E, Khaira D, Soulieres D, Dorazio P, Mariani G, Usari T, Domchek S. Tremelimumab in combination with exemestane as novel immunotherapy for patients with advanced breast cancer. Journal Of Clinical Oncology 2009, 27: 3034-3034. DOI: 10.1200/jco.2009.27.15_suppl.3034.
- Wagner A, Von Hoff D, LoRusso P, Tibes R, Mazina K, Ware J, Yan Y, Derynck M, Demetri G. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. Journal Of Clinical Oncology 2009, 27: 3501-3501. DOI: 10.1200/jco.2009.27.15_suppl.3501.
- LoRusso P, Markman B, Tabernero J, Shazer R, Nguyen L, Heath E, Patnaik A, Papadopoulos K. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2009, 27: 3502-3502. DOI: 10.1200/jco.2009.27.15_suppl.3502.
- Liu G, LoRusso P, Goncalves P, Holen K, Traynor A, Zhang J, Hee B, Tortorici M, Shalinsky D, Ricart A. Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of PF-00337210, a highly selective VEGFR inhibitor. Journal Of Clinical Oncology 2009, 27: 3519-3519. DOI: 10.1200/jco.2009.27.15_suppl.3519.
- Hoban C, Hoering A, Synold T, Chung V, Gandara D, Schott A, Kingsbury L, Lew D, LoRusso P, Gadgeel S. Phase I evaluation of lapatinib and everolimus in patients with advanced malignancies: Southwest Oncology Group trial S0528. Journal Of Clinical Oncology 2009, 27: 3553-3553. DOI: 10.1200/jco.2009.27.15_suppl.3553.
- Heath E, Blumenschein G, Cohen R, LoRusso P, LoConte N, Kim S, Chao R, Wilding G. Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results. Journal Of Clinical Oncology 2009, 27: e14509-e14509. DOI: 10.1200/jco.2009.27.15_suppl.e14509.
- Hong D, LoRusso P, Kurzrock R, Maroun C, Mehran M, Drouin M, Martell R, Wheler J. Phase I study of MGCD265 administered intermittently to patients with advanced malignancies (Study 265–102). Journal Of Clinical Oncology 2009, 27: e14516-e14516. DOI: 10.1200/jco.2009.27.15_suppl.e14516.
- Naing A, LoRusso P, Mills G, Berry D, Doyle L, Rohren E, Burger A, Chen H, Busaidy N, Kurzrock R. Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphoma. Journal Of Clinical Oncology 2009, 27: e14535-e14535. DOI: 10.1200/jco.2009.27.15_suppl.e14535.
- Li J, Sha X, LoRusso P. Pharmacogenetics of a PARP inhibitor ABT-888 metabolic pathway. Journal Of Clinical Oncology 2009, 27: e14556-e14556. DOI: 10.1200/jco.2009.27.15_suppl.e14556.
- Gadgeel S, Wozniak A, Edelman M, Valdivieso M, Heilbrun L, Venkatramanamoorthy R, Shields A, LoRusso P, Hackstock D, Ruckdeschel J. Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2009, 27: e19007-e19007. DOI: 10.1200/jco.2009.27.15_suppl.e19007.
- Vishnu P, Jasti P, Ding L, Heilbrun L, Venkatramanamoorthy R, LoRusso P, Heath E. Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan. Journal Of Clinical Oncology 2009, 27: e20626-e20626. DOI: 10.1200/jco.2009.27.15_suppl.e20626.
- LoRusso P, Burris H, Jones S, Fleming R, Koch K. In Reply. Journal Of Clinical Oncology 2009, 27: 316-317. DOI: 10.1200/jco.2008.20.0758.
- Ratain M, Smith J, Benedetti F, Elias L, LoRusso P. 438 POSTER Pharmacodynamics (PD) of GRN163L in a Phase I study in refractory, solid tumors. European Journal Of Cancer Supplements 2008, 6: 138. DOI: 10.1016/s1359-6349(08)72372-3.
- Phatak P, Daniels C, Shields A, Collins J, LoRusso P, Burger A. 468 POSTER The role of thymidine kinase and thymidylate synthase in the response of tumor cells to the suicide prodrug 2′-F-ara-deoxyuridine. European Journal Of Cancer Supplements 2008, 6: 150. DOI: 10.1016/s1359-6349(08)72402-9.
- Hurwitz H, LoRusso P, Shapiro G, Wolanksi A, Chemidlin J, Masson E, Syed S, Kollia G, Conlon K. 429 POSTER Phase 1 study of food effects on pharmacokinetics of brivanib alaninate in patients with advanced or metastatic solid tumors. European Journal Of Cancer Supplements 2008, 6: 135. DOI: 10.1016/s1359-6349(08)72363-2.
- Mita M, Spear M, Yee L, Papadopoulos K, Heath E, Pilat M, Romero O, Lloyd G, Mita A, LoRusso P. 42 POSTER NPI-2358 (a novel vascular disrupting agent) Phase 1 dose escalation trial with an RP2D cohort. European Journal Of Cancer Supplements 2008, 6: 17. DOI: 10.1016/s1359-6349(08)71974-8.
- LoRusso P, Sarker D, Von Hoff D, Tibes R, Derynck M, Ware J, Yan Y, Demetri G, de Bono J, Wagner A. 223 POSTER Pharmacokinetics and pharmacodynamic biomarkers for the pan-PI3K inhibitor GDC-0941: Initial Phase I evaluation. European Journal Of Cancer Supplements 2008, 6: 70-71. DOI: 10.1016/s1359-6349(08)72155-4.
- Krishnamurthi S, Goncalves P, Fox F, Hall N, Rowinsky E, Schwartz J, Youssoufian H, LoRusso P. 406 POSTER IMC-18F1, a recombinant human monoclonal antibody (MAb) against the vascular endothelial growth factor receptor-1 (VEGFR-1), in the treatment of patients (pts) with advanced solid malignancies: A Phase 1 study. European Journal Of Cancer Supplements 2008, 6: 127-128. DOI: 10.1016/s1359-6349(08)72340-1.
- Rudin C, Von Hoff D, LoRusso P, Vernillet L, Yauch R, Darbonne W, Mackey H, de Sauvage F, Low J, Reddy J. 355 POSTER Updated safety and efficacy data from a first-in-human, first-in-class, phase I study of Hedgehog pathway antagonist, GDC-0449. European Journal Of Cancer Supplements 2008, 6: 112-113. DOI: 10.1016/s1359-6349(08)72289-4.
- Rothenberg M, Poplin E, LoRusso P, Yu E, Schwartz J, Fox F, Mehnert J, Sandler A, Rowinsky E, Higano C. 554 POSTER Pharmacokinetic (PK) and pharmacodynamic (PD) results of Phase I studies of IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid malignancies. European Journal Of Cancer Supplements 2008, 6: 174-175. DOI: 10.1016/s1359-6349(08)72488-1.
- Markman B, LoRusso P, Patnaik A, Heath E, Laird A, van Leeuwen B, Papadopoulos K, Baselga J. 216 POSTER A phase I dose-escalation study of the safety, pharmacokinetics and pharmacodynamics of XL765, a novel inhibitor of PI3K and mTOR, administered orally to patients with solid tumors. European Journal Of Cancer Supplements 2008, 6: 68-69. DOI: 10.1016/s1359-6349(08)72148-7.
- Fracasso P, Ravaud A, Baggstrom M, LoRusso P, Jones D, Sguotti C, Urban P, Gao B, Medioni J. Patupilone combined with carboplatin in patients (pts) with advanced solid tumors: preliminary safety and activity results. Journal Of Clinical Oncology 2008, 26: 13544-13544. DOI: 10.1200/jco.2008.26.15_suppl.13544.
- Harper F, Heath E, Gleason M, LoRusso P, Albrecht T. Objective versus subjective predictors of patient clinical benefit from phase I treatment. Journal Of Clinical Oncology 2008, 26: 13526-13526. DOI: 10.1200/jco.2008.26.15_suppl.13526.
- Camacho L, Moulder S, LoRusso P, Blumenschein G, Bristow P, Kurzrock R, Fu S, Schlienger K, Bergstrom D. First in human phase I study of MK-2461, a small molecule inhibitor of c-Met, for patients with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 14657-14657. DOI: 10.1200/jco.2008.26.15_suppl.14657.
- Heath E, Blumenschein G, Cohen R, LoRusso P, LoConte N, Kim S, Chao R, Wilding G. Phase I study of sunitinib in combination with carboplatin (C) plus paclitaxel (P) in patients (pts) with advanced solid tumors (STs). Journal Of Clinical Oncology 2008, 26: 3565-3565. DOI: 10.1200/jco.2008.26.15_suppl.3565.
- Ratain M, Benedetti F, Janisch L, Khor S, Schilsky R, Cohen E, Maitland M, Elias L, LoRusso P. A phase I trial of GRN163L (GRN), a first-in-class telomerase inhibitor, in advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3581-3581. DOI: 10.1200/jco.2008.26.15_suppl.3581.
- Mahany J, Lewis N, Heath E, LoRusso P, Mita M, Rodon J, Tolcher A, Sherman B, Bradley C, Papadopoulos K. A phase IB study evaluating BSI-201 in combination with chemotherapy in subjects with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3579-3579. DOI: 10.1200/jco.2008.26.15_suppl.3579.
- Mita A, Yee L, Papadopoulos K, Heath E, Romero O, Lloyd G, Cropp G, Spear M, Mita M, LoRusso P. Phase I study of NPI-2358 (a novel vascular disrupting agent) in patients with solid tumors and lymphomas. Journal Of Clinical Oncology 2008, 26: 3525-3525. DOI: 10.1200/jco.2008.26.15_suppl.3525.
- Papadopoulos K, Markman B, Tabernero J, Patnaik A, Heath E, DeCillis A, Laird D, Aggarwal S, Nguyen L, LoRusso P. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel PI3K inhibitor, XL765, administered orally to patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3510-3510. DOI: 10.1200/jco.2008.26.15_suppl.3510.
- LoRusso P, Rudin C, Borad M, Vernillet L, Darbonne W, Mackey H, DiMartino J, de Sauvage F, Low J, Von Hoff D. A first-in-human, first-in-class, phase (ph) I study of systemic Hedgehog (Hh) pathway antagonist, GDC-0449, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3516-3516. DOI: 10.1200/jco.2008.26.15_suppl.3516.
- Krishnamurthi S, LoRusso P, Goncalves P, Fox F, Rowinsky E, Schwartz J, Youssoufian H. Phase 1 study of weekly anti-vascular endothelial growth factor receptor-1 (VEGFR-1) monoclonal antibody IMC-18F1 in patients with advanced solid malignancies. Journal Of Clinical Oncology 2008, 26: 14630-14630. DOI: 10.1200/jco.2008.26.15_suppl.14630.
- Crown J, Burris H, Di Leo A, Jagiello-Gruszfeld A, Jones S, LoRusso P, Oliva C, Parikh R, Stein S, Koehler M. Tolerability of lapatinib in combination with taxanes (T) in 507 patients with breast cancer (BC). European Journal Of Cancer Supplements 2008, 6: 200. DOI: 10.1016/s1359-6349(08)70818-8.
- Ramanathan R, Egorin M, Takimoto C, Remick S, Doroshow J, LoRusso P, Mulkerin D, Grem J, Hamilton A, Murgo A, Potter D, Belani C, Hayes M, Peng B, Ivy S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 563-569. PMID: 18235115, DOI: 10.1200/jco.2007.11.0304.
- Gibbons J, Egorin M, Ramanathan R, Fu P, Mulkerin D, Shibata S, Takimoto C, Mani S, LoRusso P, Grem J, Pavlick A, Lenz H, Flick S, Reynolds S, Lagattuta T, Parise R, Wang Y, Murgo A, Ivy S, Remick S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 570-576. PMID: 18235116, DOI: 10.1200/jco.2007.13.3819.
- LoRusso P, Bekele B, Boerner S, Davis D, Evelhoch J, Herbst R. Chapter 47 Phase 1 Trials Today. 2008, 553-570. DOI: 10.1016/b978-141603703-3.10047-0.
- Aaronson S, Abbruzzese J, Abel E, Anderson K, Arrick B, Bafico A, Barbash O, Bast R, Baylin S, Bekele B, Bertino J, Boerner S, Bommer G, Borden E, Buchstaller J, Buetow K, Burman K, Calin G, Campisi J, Caprioli R, Carroll P, Chaurand P, Ashley J, Cleveland J, Collins J, Cortes J, Costello J, Cox J, Croce C, D'Andrea A, Davis D, Deberardinis R, Demasi J, Diehl J, Digiovanni J, Dorsey F, Egeblad M, Ekmekcioglu S, Evelhoch J, Fearon E, Febbo P, Feng Z, Fletcher C, Frankel A, Friedman D, Fury M, Gambhir S, Gazdar A, Girard L, Glick A, Gonzalez-Angulo A, Gray J, Greene K, Grimm E, Grumolato L, Guertin D, Hait W, Havrda M, Hennessy B, Herbst R, Houghton A, Houghton P, Howley P, Hu W, Hwu P, Israel M, Jacks T, Jorgensen C, Kantarjian H, Keith B, Kelsen D, Korn W, Kundra P, Kurzrock R, Lee J, Levine A, Li L, Lippman S, Littlepage L, Liu Y, Look T, Lorusso P, Malkin D, Margolin J, Matrisian L, Mccormick F, Mendelsohn J, Merghoub T, Mills G, Minna J, Morrison S, Morton C, Neckers L, Nevins J, Okino S, Pardoll D, Pawson T, Payne E, Pfister D, Polsky D, Poplack D, Posada J, Powis G, Quintana E, Quintás-Cardama A, Rabin K, Reimann J, Rubin E, Sabatini D, Sato M, Sausville E, Sen G, Shah M, Shames D, Shoemaker R, Sikic B, Silverman R, Simon M, Spellman P, Steeves M, Thompson C, Tonon G, Weinberg R, Welch D, Werb Z, Winslow M, Woodward W, Xiong H, Yaghoubi S, Yuspa S. List of Contributing Authors. 2008, vii-xiii. DOI: 10.1016/b978-141603703-3.10061-5.
- Mita A, Wang D, Takimoto C, Martin D, Nguyen L, Rasmussen E, Storgard C, LoRusso P. 708 POSTER AMG 386, a first-in-class, selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. European Journal Of Cancer Supplements 2007, 5: 109-110. DOI: 10.1016/s1359-6349(07)70507-4.
- Vaishampayan U, Sausville E, Horiba M, Quinn M, Heilbrun L, Burger A, Ivy P, Li J, Lorusso P. Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit. Journal Of Clinical Oncology 2007, 25: 3531-3531. DOI: 10.1200/jco.2007.25.18_suppl.3531.
- Shields A, Heath E, DeLuca P, Pilat M, Wozniak A, Gadgeel S, Puchalski T, Xu J, Liu Q, LoRusso P. AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort study. Journal Of Clinical Oncology 2007, 25: 3544-3544. DOI: 10.1200/jco.2007.25.18_suppl.3544.
- O’Dwyer P, LoRusso P, DeMichele A, Gupta V, Barbi A, Dials H, Chen I, Courtney R, Wilner K, Schwartz G. A phase I dose escalation trial of a daily oral CDK 4/6 inhibitor PD-0332991. Journal Of Clinical Oncology 2007, 25: 3550-3550. DOI: 10.1200/jco.2007.25.18_suppl.3550.
- Wang D, Heath E, Powell A, Chaperon T, LaGrone F, LoRusso P. Barriers to phase I clinical trial protocol IRB approval at KCI. Journal Of Clinical Oncology 2007, 25: 9080-9080. DOI: 10.1200/jco.2007.25.18_suppl.9080.
- LoRusso P, Hong D, Heath E, Kurzrock R, Wang D, Hsu M, Goyal L, Wiezorek J, Storgard C, Herbst R. First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3534-3534. DOI: 10.1200/jco.2007.25.18_suppl.3534.
- Garrett C, Siu L, Giaccone G, El-Khoueiry A, Marshall J, LoRusso P, Velasquez L, Kollia G, He P, Feltquate D. A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapy. Journal Of Clinical Oncology 2007, 25: 14018-14018. DOI: 10.1200/jco.2007.25.18_suppl.14018.
- Mita A, Wang D, Takimoto C, Malseed E, Nguyen L, Rasmussen E, Storgard C, LoRusso P. AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 14033-14033. DOI: 10.1200/jco.2007.25.18_suppl.14033.
- Spear M, LoRusso P, Tolcher A, Lin C, Wang D, Heath E, Lloyd G, Cropp G, Papadopoulos K. A phase 1 dynamic accelerated titration dose escalation study of the vascular disrupting agent NPI-2358. Journal Of Clinical Oncology 2007, 25: 14097-14097. DOI: 10.1200/jco.2007.25.18_suppl.14097.
- Wagner L, Lai S, Aneja M, Lorusso P, Perez-Soler R, O’Brien B, Patel J, Lacouture M. Development of a functional assessment of side-effects to therapy (FAST) questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors (EGFRI): The FAST-EGFRI. Journal Of Clinical Oncology 2007, 25: 19532-19532. DOI: 10.1200/jco.2007.25.18_suppl.19532.
- Slapak C, LoRusso P, Mendelson D, Sykes A, De Alwis D, Wagner M, Ilaria R, Gordon M. Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 2542-2542. DOI: 10.1200/jco.2007.25.18_suppl.2542.
- Sausville E, LoRusso P, Quinn M, Forman K, Leamon C, Morganstern D, Bever S, Messmann R. A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors. Journal Of Clinical Oncology 2007, 25: 2577-2577. DOI: 10.1200/jco.2007.25.18_suppl.2577.
- Higano C, Yu E, Whiting S, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Schwartz J. A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3505-3505. DOI: 10.1200/jco.2007.25.18_suppl.3505.
- Eder J, Heath E, Appleman L, Shapiro G, Wang D, Malburg L, Zhu A, Leader T, Wolanski A, LoRusso P. Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors. Journal Of Clinical Oncology 2007, 25: 3526-3526. DOI: 10.1200/jco.2007.25.18_suppl.3526.
- LoRusso P, Appleman L, Zhu A, Shapiro G, Fox L, Wolanski A, Hitchcock-Bryan S, Malburg L, Eder J. 404 POSTER Pharmacodynamics (pd) of x1880, a novel spectrum selective kinase inhibitor (SSKI), administered orally to patients (pts) with advanced solid tumors (AST). European Journal Of Cancer Supplements 2006, 4: 124. DOI: 10.1016/s1359-6349(06)70409-8.
- Higano C, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Rowinsky E, Youssoufian H. 648 POSTER A phase I dose-escalation study of weekly IMC-A12, a fully human insulin like growth factor-I receptor (IGF-IR) IgG1 monoclonal antibody (Mab), in patients (pts) with advanced cancer. European Journal Of Cancer Supplements 2006, 4: 195. DOI: 10.1016/s1359-6349(06)70653-x.
- Bröker L, Veltkamp S, Heath E, Gall H, Kuenen B, Voi M, Kayitalire L, Lorusso P, Schellens J, Giaccone G. 644 POSTER The novel oral taxane BMS275183 has a favorable activity and toxicity profile in a twice weekly schedule; Preliminary findings from an extended phase I trial. European Journal Of Cancer Supplements 2006, 4: 194. DOI: 10.1016/s1359-6349(06)70649-8.
- Morgan J, Demetri G, Wang D, MacPherson I, LoRusso P, van den Abbeele A, Brunton V, Luo R, Voi M, Evans T. 383 POSTER A Phase I Study of dasatinib, a Src and multi-kinase inhibitor, in patients (pts) with GIST and other solid tumors. European Journal Of Cancer Supplements 2006, 4: 118. DOI: 10.1016/s1359-6349(06)70388-3.
- Heath E, Alousi A, Eder J, Valdivieso M, Vasist L, Appleman L, Bhargava P, Colevas A, Lorusso P, Shapiro G. A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 2026-2026. DOI: 10.1200/jco.2006.24.18_suppl.2026.
- Lorusso P, Heath E, Valdivieso M, Pilat M, Wozniak A, Gadgeel S, Shields A, Puchalski T, Ewesuedo R. Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 3034-3034. DOI: 10.1200/jco.2006.24.18_suppl.3034.
- Eder J, Appleman L, Heath E, Malburg L, Zhu A, Pilat M, Shapiro G, Lorusso P. A phase I study of a novel spectrum selective kinase inhibitor (SSKI), XL880, administered orally in patients (pts) with advanced solid tumors (STs). Journal Of Clinical Oncology 2006, 24: 3041-3041. DOI: 10.1200/jco.2006.24.18_suppl.3041.
- Gale R, Van Vugt A, Rosen L, Chang L, Lorusso P, Valdivieso M, Malburg L, Struck R, Morgan L. Phase-1 study of isophosphoramide mustard (IPM)-lysine in advanced cancers. Journal Of Clinical Oncology 2006, 24: 9524-9524. DOI: 10.1200/jco.2006.24.18_suppl.9524.
- Krop I, Kosh M, Fearen I, Savoie J, Dallob A, Matthews C, Stone J, Winer E, Freedman S, Lorusso P. Phase I pharmacokinetic (PK), and pharmacodynamic (PD) trial of the novel oral Notch inhibitor MK-0752 in patients (pts) with advanced breast cancer (BC) and other solid tumors. Journal Of Clinical Oncology 2006, 24: 10574-10574. DOI: 10.1200/jco.2006.24.18_suppl.10574.
- Wadler S, Loh E, Pilat M, Malburg L, Holloway S, Matthews N, Shackleton G, Valdivieso M, Lorusso P. A phase I trial of SR271425 given as a one hour infusion every 3 weeks to patients with advanced solid tumors. Journal Of Clinical Oncology 2005, 23: 2030-2030. DOI: 10.1200/jco.2005.23.16_suppl.2030.
- Broker L, Ruyter R, Voi M, Woo M, Astier L, Heath E, Lorusso P, Giaccone G. A phase I trial investigating a twice weekly administration of the oral taxane BMS-275183 in patients with advanced solid tumors. Journal Of Clinical Oncology 2005, 23: 2040-2040. DOI: 10.1200/jco.2005.23.16_suppl.2040.
- Woo M, Broker L, Pilat M, Malburg L, Cohen M, Griffin T, Valdivieso M, Giaccone G, Lorusso P. The effect of food on the pharmacokinetics of BMS-275183, a novel oral taxane, in patients with advanced solid malignancies. Journal Of Clinical Oncology 2005, 23: 2053-2053. DOI: 10.1200/jco.2005.23.16_suppl.2053.
- Kraut E, Fishman M, Lorusso P, Gordon M, Rubin E, Haas A, Fetterly G, Cullinan P, Dul J, Steinberg J. Final results of a phase I study of liposome encapsulated SN-38 (LE-SN38): Safety, pharmacogenomics, pharmacokinetics, and tumor response. Journal Of Clinical Oncology 2005, 23: 2017-2017. DOI: 10.1200/jco.2005.23.16_suppl.2017.
- Menon S, Whitfield L, Sadis S, Meyer M, Leopold J, Lorusso P, Krishnamurthi S, Rinehart J, Nabell L, Croghan G. Pharmacokinetics (PK) and pharmacodynamics (PD) of PD 0325901, a second generation MEK inhibitor after multiple oral doses of PD 0325901 to advanced cancer patients. Journal Of Clinical Oncology 2005, 23: 3066-3066. DOI: 10.1200/jco.2005.23.16_suppl.3066.
- Lorusso P, Krishnamurthi S, Rinehart J, Nabell L, Croghan G, Varterasian M, Sadis S, Menon S, Leopold J, Meyer M. A phase 1–2 clinical study of a second generation oral MEK inhibitor, PD 0325901 in patients with advanced cancer. Journal Of Clinical Oncology 2005, 23: 3011-3011. DOI: 10.1200/jco.2005.23.16_suppl.3011.
- Herbst RS, LoRusso P, Isobe T, Hurwitz HI. Angiogenesis pathway inhibitors. Cancer Chemotherapy And Biological Response Modifiers 2005, 22: 225-45. PMID: 16110614, DOI: 10.1016/s0921-4410(04)22010-5.
- El-Rayes B, LoRusso P. The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast Cancer. American Journal Of Cancer 2004, 3: 369-375. DOI: 10.2165/00024669-200403060-00004.
- LoRusso P. 460 Clinical development of AVE 8062 and ZD6126. European Journal Of Cancer Supplements 2004, 2: 139. DOI: 10.1016/s1359-6349(04)80468-3.
- LoRusso P, Fishman M, Kraut E, Gordon M, Elsayed Y, Steinberg J, Nieves J, Wanaski S, Dul J, Sherman J. 501 Prospective UGT1A1 genotyping in a phase I study of safety and pharmacokinetics of liposome encapsulated SN-38 (LE-SN38). European Journal Of Cancer Supplements 2004, 2: 153. DOI: 10.1016/s1359-6349(04)80509-3.
- Benson A, Rubin E, Beers S, Mucci-Lorusso P, Vermuelen W, Denis L, Compton L, Pavlov D, Rothenberg M. Phase I dose escalation and safety study of a semi-solid matrix (SSM) formulation of oral irinotecan and capecitabine tablets in patients with advanced solid tumors. Journal Of Clinical Oncology 2004, 22: 2042-2042. DOI: 10.1200/jco.2004.22.14_suppl.2042.
- Benson A, Rubin E, Beers S, Mucci-Lorusso P, Vermuelen W, Denis L, Compton L, Pavlov D, Rothenberg M. Phase I dose escalation and safety study of a semi-solid matrix (SSM) formulation of oral irinotecan and capecitabine tablets in patients with advanced solid tumors. Journal Of Clinical Oncology 2004, 22: 2042-2042. DOI: 10.1200/jco.2004.22.90140.2042.
- Burris H, Lorusso P, Jones S, Guthrie T, Orr J, Williams D, Hodge J, Bush M, Sabry J. Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 days. Journal Of Clinical Oncology 2004, 22: 2004-2004. DOI: 10.1200/jco.2004.22.14_suppl.2004.
- Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.14_suppl.2017.
- Alousi A, Parchment R, Boinpally R, Gadgeel S, Weigand R, McCormick J, Lorusso P. Phase I clinical trial of XK469 in patients with chemo-refractory solid tumors. Journal Of Clinical Oncology 2004, 22: 2020-2020. DOI: 10.1200/jco.2004.22.14_suppl.2020.
- Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancersSyed S, Beeram M, Takimoto C, Jakubowitz J, Kimura M, Ducharme M, Gadgeel S, De Jager R, Rowinsky E, Lorusso P. Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancers. Journal Of Clinical Oncology 2004, 22: 2028-2028. DOI: 10.1200/jco.2004.22.14_suppl.2028.
- Letrent S, Callegari F, Wong T, Burris H, Cohen R, Lorusso P, Papadimitrakopoulou V, Shapiro G, Griffin T, Decillis A. Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032. Journal Of Clinical Oncology 2004, 22: 2031-2031. DOI: 10.1200/jco.2004.22.14_suppl.2031.
- Sweeney C, Saif M, Lorusso P, Ducharme M, Demnati R, Danna M, Rowinsky E, Mita M, Dejager R, Takimoto C. A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunction. Journal Of Clinical Oncology 2004, 22: 2069-2069. DOI: 10.1200/jco.2004.22.14_suppl.2069.
- Kraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients. Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.14_suppl.2501.
- Rinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer. Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.14_suppl.3100.
- Burris H, Lorusso P, Jones S, Guthrie T, Orr J, Williams D, Hodge J, Bush M, Sabry J. Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 days. Journal Of Clinical Oncology 2004, 22: 2004-2004. DOI: 10.1200/jco.2004.22.90140.2004.
- Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.90140.2017.
- Alousi A, Parchment R, Boinpally R, Gadgeel S, Weigand R, McCormick J, Lorusso P. Phase I clinical trial of XK469 in patients with chemo-refractory solid tumors. Journal Of Clinical Oncology 2004, 22: 2020-2020. DOI: 10.1200/jco.2004.22.90140.2020.
- Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancersSyed S, Beeram M, Takimoto C, Jakubowitz J, Kimura M, Ducharme M, Gadgeel S, De Jager R, Rowinsky E, Lorusso P. Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancers. Journal Of Clinical Oncology 2004, 22: 2028-2028. DOI: 10.1200/jco.2004.22.90140.2028.
- Letrent S, Callegari F, Wong T, Burris H, Cohen R, Lorusso P, Papadimitrakopoulou V, Shapiro G, Griffin T, Decillis A. Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032. Journal Of Clinical Oncology 2004, 22: 2031-2031. DOI: 10.1200/jco.2004.22.90140.2031.
- Sweeney C, Saif M, Lorusso P, Ducharme M, Demnati R, Danna M, Rowinsky E, Mita M, Dejager R, Takimoto C. A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunction. Journal Of Clinical Oncology 2004, 22: 2069-2069. DOI: 10.1200/jco.2004.22.90140.2069.
- Kraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients. Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.90140.2501.
- Rinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer. Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.90140.3100.
- Averbuch S, Wolf M, El‐Rayes B, LoRusso P. Clinical Development Issues. 2004, 287-306. DOI: 10.1002/047165616x.ch13.
- Corbett T, Polin L, LoRusso P, Valeriote F, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 2004, 99-123. DOI: 10.1007/978-1-59259-739-0_6.
- Burris H, LoRusso P, Jones S, McCormick J, Willcutt N, Hodge J, Bush P, Pandite L, Sabry J, Ho P. 570 A phase I study to determine the safety and pharmacokinetics of intravenous administration of SB715992 on a once weekly for three consecutive weeks schedule in patients with refractory solid tumors. European Journal Of Cancer Supplements 2003, 1: s172-s173. DOI: 10.1016/s1359-6349(03)90602-1.
- Budd G, Evelhoch J, Langmuir P, Veiero J, Shepherdson K, LoRusso P. 546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatments. European Journal Of Cancer Supplements 2003, 1: s165. DOI: 10.1016/s1359-6349(03)90578-7.
- Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. Journal Of Clinical Oncology 2002, 20: 110-24. PMID: 11773160, DOI: 10.1200/jco.2002.20.1.110.
- Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.
- LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. DOI: 10.1053/sonc.2001.25437.
- LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. PMID: 11544572, DOI: 10.1016/s0093-7754(01)90228-3.
- Albanell J, Rojo F, Averbuch S, Feyereislova A, Herbst R, LoRusso P, Rischin D, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the specific oral EGFR tyrosine kinase inhibitor (EGFR-TKI) zd1839 (‘Iressa’) in skin from cancer patients participating in phase I trials: histopathological and molecular consequences of receptor inhibition. European Journal Of Cancer 2001, 37: s159. DOI: 10.1016/s0959-8049(01)81071-6.
- Prakash S, Foster B, Meyer M, Wozniak A, Heilbrun L, Flaherty L, Zalupski M, Radulovic L, Valdivieso M, LoRusso P. Chronic Oral Administration of CI-994: A Phase I Study. Investigational New Drugs 2001, 19: 1-11. PMID: 11291827, DOI: 10.1023/a:1006489328324.
- Kris M, Herbst R, Rischin D, LoRusso P, Baselga J, Hammond L, Feyereislova A, Ochs J, Averbuch S. Objective regressions in non-small cell lung cancer patients treated in Phase I trials of oral ZD1839 (IressaTM), a selective tyrosine kinase inhibitor that blocks the epidermal growth factor receptor (EGFR). Lung Cancer 2000, 29: 72. DOI: 10.1016/s0169-5002(00)80233-0.
- Shields A, Philip P, LoRusso P, Ferris A, Zalupski M. Phase II study of CI-958 in colorectal cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 162-164. PMID: 9923823, DOI: 10.1007/s002800050878.
- Blum J, Jones S, Buzdar A, LoRusso P, Kuter I, Vogel C, Osterwalder B, Burger H, Brown C, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. Journal Of Clinical Oncology 1999, 17: 485-93. PMID: 10080589, DOI: 10.1200/jco.1999.17.2.485.
- Corbett T, Panchapor C, Polin L, Lowichik N, Pugh S, White K, Kushner J, Meyer J, Czarnecki J, Chinnukroh S, Edelstein M, LoRusso P, Heilbrun L, Horwitz J, Grieshaber C, Perni R, Wentland M, Coughlin S, Elenbaas S, Philion R, Rake J. Preclinical efficacy of thioxanthone SR271425 against transplanted solid tumors of mouse and human origin. Investigational New Drugs 1999, 17: 17-27. PMID: 10555119, DOI: 10.1023/a:1006267517726.
- Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan DetroitSimon M, Brown D, Du W, LoRusso P, Kellogg C. Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit. American Journal Of Clinical Oncology 1999, 22: 42-46. PMID: 10025379, DOI: 10.1097/00000421-199902000-00011.
- Mucci‐LoRusso P, Berman B, Silberstein P, Citron M, Bressler L, Weinstein S, Kaiko R, Buckley B, Reder R. Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study. European Journal Of Pain 1998, 2: 239-249. PMID: 15102384, DOI: 10.1016/s1090-3801(98)90020-9.
- Corbett T, LoRusso P, Demchick L, Simpson C, Pugh S, White K, Kushner J, Polin L, Meyer J, Czarnecki J, Heilbrun L, Horwitz J, Gross J, Behrens C, Harrison B, McRipley R, Trainor G. Preclinical antitumor efficacy of analogs of XK469: sodium-(2-[4-(7-chloro-2-quinoxalinyloxy)phenoxy]propionate. Investigational New Drugs 1998, 16: 129-139. PMID: 9848576, DOI: 10.1023/a:1006174622061.
- Zalupski M, Shields A, Philip P, Kraut M, LoRusso P, Heilbrun L, Vaitkevicius V. Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma. Investigational New Drugs 1998, 16: 93-96. PMID: 9740550, DOI: 10.1023/a:1006087114621.
- Zalupski M, Philip P, LoRusso P, Shields A. Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma. Cancer Chemotherapy And Pharmacology 1997, 40: 225-227. PMID: 9219505, DOI: 10.1007/s002800050650.
- Polin L, Valeriote F, White K, Panchapor C, Pugh S, Knight J, LoRusso P, Hussain M, Liversidge E, Peltier N, Golakoti T, Patterson G, Moore R, Corbett T. Treatment of human prostate tumors PC-3 and TSU-PR1 with standard and investigational agents in SCID mice. Investigational New Drugs 1997, 15: 99-108. PMID: 9220288, DOI: 10.1023/a:1005856605726.
- Corbett T, Valeriote F, LoRusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 1997, 75-99. DOI: 10.1007/978-1-4615-8152-9_5.
- LoRusso P, Demchik L, Foster B, Knight J, Bissery M, Polin L, Leopold W, Corbett T. Preclinical antitumor activity of CI-994. Investigational New Drugs 1996, 14: 349-356. PMID: 9157069, DOI: 10.1007/bf00180810.
- Corbett T, Valeriote F, Demchik L, Polin L, Panchapor C, Pugh S, White K, Knight J, Jones J, Jones L, LoRusso P, Foster B, Wiegand R, Lisow L, Golakoti T, Heltzel C, Ogino J, Patterson G, Moore R. Preclinical anticancer activity of cryptophycin-8. Journal Of Experimental Therapeutics And Oncology 1996, 1: 95-108. PMID: 9414393.
- Djuric Z, Heilbrun L, Simon M, Smith D, Luongo D, LoRusso P, Martino S. Levels of 5‐hydroxymethyl‐2′‐deoxyuridine in DNA from blood as a marker of breast cancer. Cancer 1996, 77: 691-696. PMID: 8616761, DOI: 10.1002/(sici)1097-0142(19960215)77:4<691::aid-cncr15>3.0.co;2-w.
- Foster B, LoRusso P, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L, Kasunic D, Earhart R, Baker L. Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks. Investigational New Drugs 1995, 13: 321-326. PMID: 8824350, DOI: 10.1007/bf00873138.
- LoRusso P, Foster B, Poplin E, McCormick J, Kraut M, Flaherty L, Heilbrun L, Valdivieso M, Baker L. Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934). Clinical Cancer Research 1995, 1: 1487-93. PMID: 9815948.
- LoRusso P, Demchik L, Dan M, Polin L, Gross J, Corbett T. Comparative efficacy of DMP 840 against mouse and human solid tumor models. Investigational New Drugs 1995, 13: 195-203. PMID: 8729946, DOI: 10.1007/bf00873800.
- Corbett T, Valeriote F, Lorusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lowichik N, Biernat L, Foster B, Wozniak A, Lisow L, Valdivieso M, Baker L, Leopold W, Sebolt J, Bissery M, Mattes K, Dzubow J, Rake J, Perni R, Wentland M, Coughlin S, Shaw J, Liversidge G, Liversidge E, Bruno J, Sarpotdar P, Moore R, Patterson G. Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents. Pharmaceutical Biology 1995, 33: 102-122. DOI: 10.3109/13880209509067092.
- Valeriote F, Corbett T, Lorusso P, Moore R, Scheuer P, Patterson G, Paul V, Grindey G, Bonjouklian R, Pearce H, Suffness M. Discovery of Anticancer Agents from Natural Products. Pharmaceutical Biology 1995, 33: 59-66. DOI: 10.3109/13880209509067088.
- Corbett T, Lowichik N, Pugh S, Polin L, Panchapor C, White K, Knight J, Demchik L, Jones J, Jones L, Biernat L, Lorusso P, Foster B, Heilbrun L, Rake J, Mattes K, Perni R, Powles R, Hlavac A, Wentland M, Coughlin S, Baker L, Valeriote F. Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues. Expert Opinion On Investigational Drugs 1994, 3: 1281-1292. DOI: 10.1517/13543784.3.12.1281.
- Poplin E, LoRusso P, Lokich J, Gullo J, Leming P, Schulz J, Veach S, McCulloch W, Baker L, Schein P. Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer. Cancer Chemotherapy And Pharmacology 1994, 33: 415-419. PMID: 8306416, DOI: 10.1007/bf00686271.
- Visscher D, Sarkar F, LoRusso P, Sakr W, Ottosen S, Wykes S, Crissman J. Immunohistologic evaluation of invasion-associated proteases in breast carcinoma. Modern Pathology 1993, 6: 302-6. PMID: 8346178.
- Corbett T, Valeriote F, Polin L, Panchapor C, Pugh S, White K, Lowichik N, Knight J, Bissery M, Wozniak A, LoRusso P, Biernat L, Polin D, Knight L, Biggar S, Looney D, Demchik L, Jones J, Jones L, Blair S, Palmer K, Essenmacher S, Lisow L, Mattes K, Cavanaugh P, Rake J, Baker L. Discovery of Solid Tumor Active Agents Using a Soft-Agar-Colony-Formation Disk-Diffusion-Assay. Developments In Oncology 1992, 35-87. DOI: 10.1007/978-1-4615-3492-1_3.
- LoRusso P, Wozniak A, Polin L, Capps D, Leopold W, Werbel L, Biernat L, Dan M, Corbett T. Antitumor efficacy of PD115934 (NSC 366140) against solid tumors of mice. Cancer Research 1990, 50: 4900-5. PMID: 2165850.
- Mucci-LoRusso P, Polin L, Biernat L, Valeriote F, Corbett T. Activity of datelliptium acetate (NSC 311152; SR 95156A) against solid tumors of mice. Investigational New Drugs 1990, 8: 253-261. PMID: 2177044, DOI: 10.1007/bf00171834.
- LoRusso P, Pazdur R, Redman B, Kinzie J, Vaitkevicius V. Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin. American Journal Of Clinical Oncology 1989, 12: 486-490. PMID: 2686394, DOI: 10.1097/00000421-198912000-00005.
- Mucci-LoRusso P, Polin L, Bissery M, Valeriote F, Plowman J, Luk G, Corbettv T. Activity of batracylin (NSC-320846) against solid tumors of mice. Investigational New Drugs 1989, 7: 295-306. PMID: 2557298, DOI: 10.1007/bf00173759.
- Corbett T, Bissery M, Mucci-LoRusso P, Polin L. 5-Fluorouracil containing combinations in murine tumor systems. Investigational New Drugs 1989, 7: 37-49. PMID: 2661481, DOI: 10.1007/bf00178190.
- Lorusso P, Tapazoglou E, Kish J, Ensley J, Cummings G, Kelly J, Al‐Sarraf M. Chemotherapy for paranasal sinus carcinoma. A 10‐year experience at Wayne state university. Cancer 1988, 62: 1-5. PMID: 2454717, DOI: 10.1002/1097-0142(19880701)62:1<1::aid-cncr2820620102>3.0.co;2-f.
Departments and Programs
Locations
- Smilow Cancer Hospital Phase I Unit55 Park StreetSte First FloorNew Haven, CT 06511
Biography
Oncologist Patricia LoRusso, DO, associate director of innovative medicine at Yale Medicine, has expertise in testing new treatments on patient volunteers who have advanced stages of cancer. Her passion is bringing research breakthroughs into the clinic to help patients with different types and stages of cancer.
The clinical trials at Yale Cancer Center offer access to experimental drugs that are sometimes a patient’s last and best hope, says Dr. LoRusso. Therapies that prove successful can advance through the U.S. Food and Drug Administration approval process. “Many of the drugs tested here will help generations of cancer patients,” says Dr. LoRusso. In her career, 14 cancer drugs she has performed clinical trials on, which she refers to as her “children,” have gone on to gain FDA approval.
Dr. LoRusso leads the Phase I clinical trials infusion center at Smilow Cancer Hospital at Yale New Haven. She infuses the center with a warm, team-focused approach that puts patients at the center of care. “We’re improving patients’ lives in Connecticut and beyond,” says Dr. LoRusso.
Titles
- Amy and Joseph Perella Professor of Medicine (Medical Oncology)
- Chief, Experimental Therapeutics
- Associate Cancer Center Director, Experimental Therapeutics
Education & Training
- MAYale University (2015)
- FellowshipWayne State University (1988)
- ResidencyRiverside Osteopathic Hospital (1984)
- InternshipRiverside Osteopathic Hospital (1982)
- DOMichigan State University (1981)
- BSMarygrove College (1977)
Additional Information
Honors & Recognitions
- Fellow: American Society of Clinical Oncology (ASCO) (2022)
- Joseph H. Burchenal Award for Outstanding Achievement in Clinical Cancer Research: American Association for Cancer Research (2022)
Board Certifications
- American Osteopathic Board of Internal Medicine, Medical Oncology (1991)
- American Osteopathic Board of Internal Medicine, Internal Medicine (1987)
Publications
- Shimizu T, Powderly J, Razak A, LoRusso P, Miller K, Kao S, Kongpachith S, Tribouley C, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman R, Golan T, Tolcher A. First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors. Frontiers In Oncology 2024, 14: 1376551. DOI: 10.3389/fonc.2024.1376551.
- Yap T, Dowlati A, Dagogo-Jack I, Vibert J, Spira A, Garcia V, Punekar S, Calvo E, Sonpavde G, Awad M, Riess J, Hernández-Guerrero T, Herzberg B, Italiano A, Swalduz A, LoRusso P, Smit E, Garon E, Novotny W, Guo R. 1 Oral: First Clinical Results from A Phase 1 Trial of PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Patients with Advanced Solid Tumors with a SMARCA4 Mutation. European Journal Of Cancer 2024, 211: 114530. DOI: 10.1016/j.ejca.2024.114530.
- 616MO Long-term follow-up of single-agent divarasib in patients with KRAS G12C-positive solid tumorsGarralda E, Patel M, Kim T, Sacher A, Forster M, Santoro A, Desai J, Paz-Ares L, Gonzalez A, De Miguel M, Bowyer S, Dziadziuszko R, Kim S, Han S, Krebs M, Lorusso P, Cosman R, Chang J, Jun T, Miller W. 616MO Long-term follow-up of single-agent divarasib in patients with KRAS G12C-positive solid tumors. Annals Of Oncology 2024, 35: s494. DOI: 10.1016/j.annonc.2024.08.683.
- Park W, Kasi A, Spira A, Berlin J, Wang J, Herzberg B, Kuboki Y, Kitano S, Pelster M, Goldman J, Morgensztern D, Kondo S, Jänne P, Fujii H, Lee H, Gill S, Saci A, Lorusso P, Tolcher A. 608O Preliminary safety and clinical activity of ASP3082, a first-in-class, KRAS G12D selective protein degrader in adults with advanced pancreatic (PC), colorectal (CRC), and non-small cell lung cancer (NSCLC). Annals Of Oncology 2024, 35: s486-s487. DOI: 10.1016/j.annonc.2024.08.675.
- Wentzel K, Peguero J, Kummar S, Lorusso P, Mehnert J, Spira A, Naing A, Hamid O, Mehmi I, Benhadji K, Alland L, Hu X, Xiao H, Bao X, Chen J, Gong Y, Liu X. 1000MO A phase I/II, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors. Annals Of Oncology 2024, 35: s680-s681. DOI: 10.1016/j.annonc.2024.08.1059.
- Lorusso P, Meric-Bernstam F, Hafez N, Rivera I, Tripathy D, Wilks S, Pearson P, Needle M, Tolcher A. 669P CBX-12-101: Final results of a phase I study of CBX-12, a peptide drug conjugate (PDC) in patients (pts) with metastatic solid tumors. Annals Of Oncology 2024, 35: s525. DOI: 10.1016/j.annonc.2024.08.735.
- Guo R, Dowlati A, Dagogo-Jack I, Vibert J, Spira A, Garcia V, Punekar S, Calvo E, Sonpavde G, Awad M, Riess J, Guerrero T, Herzberg B, Italiano A, Swalduz A, Lorusso P, Smit E, Garon E, Novotny W, Yap T. 603O First clinical results from a phase I trial of PRT3789: A first-in-class intravenous SMARCA2 degrader, in patients with advanced solid tumors with a SMARCA4 mutation. Annals Of Oncology 2024, 35: s483-s484. DOI: 10.1016/j.annonc.2024.08.670.
- Luke J, Gao X, Olszanski A, Sanborn R, Falchook G, Patel S, Bedard P, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Ramesh R, Xu R, Wu B, Ding K, Raizer J, Lorusso P. 996MO Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced/metastatic solid tumors: Data from phase I dose escalation. Annals Of Oncology 2024, 35: s678-s679. DOI: 10.1016/j.annonc.2024.08.1055.
- Perets R, Stemmer S, Geva R, Golan T, Fakih M, Cohen J, Lieu C, Jin Z, Lorusso P, Friedman I, Hakim M, Ziv D, Hashmueli S, Mandel I, Moshe T, Crawford N, Abbadessa G, Perez R, Wu M, Borad M. 990O Final results from phase I, first-in-human, dose escalation study of a first-in-class anti-ILT2 antibody, SAR444881, alone and with pembrolizumab or cetuximab, in patients with advanced solid tumors. Annals Of Oncology 2024, 35: s675. DOI: 10.1016/j.annonc.2024.08.1049.
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- Yap T, Lakhani N, Patnaik A, Lee E, Gutierrez M, Moore K, Carneiro B, Hays J, Huang M, LoRusso P, Wylie A, Cadzow L, Goulet M, Tobin E, Krieter O, Schmid D, Blake S, Dieterich M, Jamois C, Harris P. First-in-human phase I trial of the oral first-in-class ubiquitin specific peptidase 1 (USP1) inhibitor KSQ-4279 (KSQi), given as single agent (SA) and in combination with olaparib (OLA) or carboplatin (CARBO) in patients (pts) with advanced solid tumors, enriched for deleterious homologous recombination repair (HRR) mutations. Journal Of Clinical Oncology 2024, 42: 3005-3005. DOI: 10.1200/jco.2024.42.16_suppl.3005.
- Stockton S, Shyr C, Cecchini M, Aljumaily R, Halfdanarson T, Sonbol M, Whisenant J, Ivy S, LoRusso P, Das S, Gore S, Berlin J, Beumer J, Heumann T. A phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation. Journal Of Clinical Oncology 2024, 42: 3076-3076. DOI: 10.1200/jco.2024.42.16_suppl.3076.
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- Yap T, Sharma M, Hamilton E, Lorusso P, Basu C, Delioukina M, Liu F, Neumann H, Park J, Giordano A. 184MO First-in-human phase I/IIa study of the first-in-class, next-generation CDK4-selective inhibitor PF-07220060 in combination with endocrine therapy (ET) in patients (pts) with HR+/HER2− metastatic breast cancer (mBC) who progressed on prior CDK4/6 inhibitors (CDK4/6i): Safety and efficacy update. ESMO Open 2024, 9: 103206. DOI: 10.1016/j.esmoop.2024.103206.
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- Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.
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- Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.
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- Kim T, Bedard P, LoRusso P, Gordon M, Bendell J, Oh D, Ahn M, Garralda E, D’Angelo S, Desai J, Hodi F, Wainberg Z, Delord J, Cassier P, Cervantes A, Gil-Martin M, Wu B, Patil N, Jin Y, Hoang T, Mendus D, Wen X, Meng R, Cho B. Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors. JAMA Oncology 2023, 9: 1574-1582. PMID: 37768658, PMCID: PMC10540058, DOI: 10.1001/jamaoncol.2023.3867.
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- Dagogo-Jack I, Dowlati A, Guo R, Awad M, Swalduz A, Calvo E, Garcia V, Adjei A, Lorusso P, Punekar S, Leal T, Yap T, Italiano A, Novotny W, Tankersley C, Rowe S, Paris G, Sun W, Spira A, Besse B. 713TiP A phase I study of PRT3789, a potent and selective degrader of SMARCA2 in patients with advanced or metastatic solid tumors and a SMARCA4 mutation. Annals Of Oncology 2023, 34: s493-s494. DOI: 10.1016/j.annonc.2023.09.1899.
- Olszanski A, Luke J, LoRusso P, Falchook G, Bedard P, Sanborn R, Patel S, Orr D, Gibbs J, Li C, Huang Y, Gregory R, Perera S, Xu R, Joshi A, Lee M, Raizer J, Gao X. 1029P Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced or metastatic solid tumors: Preliminary safety, PK/PD, and anti-tumor activity in a phase I dose escalation study supporting a recommended dose for expansion (RDE). Annals Of Oncology 2023, 34: s625-s626. DOI: 10.1016/j.annonc.2023.09.2168.
- Sacher A, LoRusso P, Patel M, Miller W, Garralda E, Forster M, Santoro A, Falcon A, Kim T, Paz-Ares L, Bowyer S, de Miguel M, Han S, Krebs M, Lee J, Cheng M, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin M, Royer-Joo S, Chang J, Dharia N, Schutzman J, Desai J. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. New England Journal Of Medicine 2023, 389: 710-721. PMID: 37611121, DOI: 10.1056/nejmoa2303810.
- Doroshow D, Wei W, Mehrotra M, Sia D, Eder J, Bindra R, Houldsworth J, LoRusso P, Walther Z. Platinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal. Cancer Investigation 2023, 41: 646-655. PMID: 37505929, DOI: 10.1080/07357907.2023.2242957.
- Garralda E, Schram A, Bedard P, Schwartz G, Yuen E, McNeely S, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. The Oncologist 2023, 29: e131-e140. PMID: 37531083, PMCID: PMC10769797, DOI: 10.1093/oncolo/oyad215.
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- Cecchini M, Zhang J, Wei W, Sklar J, Lacy J, Zhong M, Kong Y, Zhao H, DiPalermo J, Devine L, Stein S, Kortmansky J, Johung K, Bindra R, LoRusso P, Schalper K. Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer. Cancer Research Communications 2023, 3: 1132-1139. PMID: 37387791, PMCID: PMC10305782, DOI: 10.1158/2767-9764.crc-23-0045.
- Cecchini M, Walther Z, Wei W, Hafez N, Pilat M, Boerner S, Durecki D, Eder J, Schalper K, Chen A, LoRusso P. NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors. Cancer Research Communications 2023, 3: 1113-1117. PMID: 37377610, PMCID: PMC10292219, DOI: 10.1158/2767-9764.crc-22-0485.
- Amengual J, Shyr Y, Durecki D, Beumer J, Mansukhani M, Williams M, Kelleher N, Cherng H, Pro B, Schwartz G, LoRusso P, Piekarz R. ETCTN P10500: PHASE 1/EXPANSION STUDY OF TAZEMETOSTAT PLUS BELINOSTAT FOR THE TREATMENT OF RELAPSED OR REFRACTORY LYMPHOMA. Hematological Oncology 2023, 41: 833-834. DOI: 10.1002/hon.3166_ot14.
- LoRusso P, Yamamoto N, Patel M, Laurie S, Bauer T, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder M. The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study. Cancer Discovery 2023, 13: 1802-1813. PMID: 37269344, PMCID: PMC10401071, DOI: 10.1158/2159-8290.cd-23-0153.
- Sommerhalder D, Hamilton E, Mukohara T, Yonemori K, Mita M, Yamashita T, Zheng J, Liu L, Maity A, Homji Mishra N, Bogg O, Li M, LoRusso P. First-in-human phase 1 dose escalation study of the KAT6 inhibitor PF-07248144 in patients with advanced solid tumors. Journal Of Clinical Oncology 2023, 41: 1054-1054. DOI: 10.1200/jco.2023.41.16_suppl.1054.
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- Winer I, Patnaik A, Barve M, Kummar S, Schenk E, LoRusso P, Yeku O, Fu S, Jahchan N, Myers M, Liang L, Deegan D, Jackson L, Li Y, Reyno L, Chamberlain M. A phase 1a dose-escalation study of PY159, a monoclonal antibody targeting TREM1 (triggering receptor expressed on myeloid cells 1). Journal Of Clinical Oncology 2023, 41: 2523-2523. DOI: 10.1200/jco.2023.41.16_suppl.2523.
- Peltzer A, Hesse R, Gounder M, Yamamoto N, Patel M, Laurie S, Bauer T, Teufel M, Geng J, LoRusso P. Longitudinal mutational analysis of TP53 in plasma circulating tumor DNA (ctDNA) in patients (pts) with solid tumors in a phase I study of BI 907828, an MDM2–p53 antagonist. Journal Of Clinical Oncology 2023, 41: 3036-3036. DOI: 10.1200/jco.2023.41.16_suppl.3036.
- Maldonado E, Rathmell W, Shapiro G, Rodon Ahnert J, Mahalingam D, Trikalinos N, Rezazadeh A, Adorno Febles V, Parikh M, Boerner S, Krings G, Takebe N, LoRusso P, Aggarwal R. A phase 2 study of the WEE1 inhibitor AZD1775 in SETD2-deficient advanced solid tumor malignancies. Journal Of Clinical Oncology 2023, 41: 3104-3104. DOI: 10.1200/jco.2023.41.16_suppl.3104.
- Carneiro B, Perets R, Dowlati A, LoRusso P, Yonemori K, He L, Munasinghe W, Noorani B, Johnson E, Zugazagoitia J. Mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose expansion results. Journal Of Clinical Oncology 2023, 41: 3027-3027. DOI: 10.1200/jco.2023.41.16_suppl.3027.
- Yap T, Giordano A, Hamilton E, LoRusso P, Bowers M, Basu C, Billotte S, Delioukina M, Liu F, Yang J, Sharma M. First-in-human first-in-class phase 1/2a study of the next generation CDK4-selective inhibitor PF-07220060 in patients (pts) with advanced solid tumors, enriched for HR+ HER2- mBC who progressed on prior CDK4/6 inhibitors and endocrine therapy. Journal Of Clinical Oncology 2023, 41: 3009-3009. DOI: 10.1200/jco.2023.41.16_suppl.3009.
- Rodriguez Rivera I, Hafez N, Tolcher A, LoRusso P, Wilks S, Tripathy D, Gara M, Pearson P, DeCillis A, Meric-Bernstam F. CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2023, 41: 3087-3087. DOI: 10.1200/jco.2023.41.16_suppl.3087.
- Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Eck S, Jiang Y, Khan A, Wu Y, Martin P, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Patel S. First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors. Cancer Immunology, Immunotherapy 2023, 72: 2443-2458. PMID: 37016126, PMCID: PMC10264501, DOI: 10.1007/s00262-023-03430-6.
- Schoeffski P, Yamamoto N, Bauer T, Patel M, Lorusso P, Lahmar M, Durland-Busbice S, Geng J, Gounder M. 42O A phase Ia/b, dose-escalation and expansion study evaluating the MDM2–p53 antagonist BI 907828 in patients with solid tumours: Safety and efficacy in patients with dedifferentiated liposarcoma (DDLPS). ESMO Open 2023, 8: 101079. DOI: 10.1016/j.esmoop.2023.101079.
- Fanucci K, Pilat M, Shyr D, Shyr Y, Boerner S, Li J, Durecki D, Drappatz J, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma. Cancer Research Communications 2023, 3: 192-201. PMID: 36968138, PMCID: PMC10035510, DOI: 10.1158/2767-9764.crc-22-0436.
- Stockton S, Dan A, Cecchini M, Ajumaily R, Whisenant J, Gore S, Ivy P, LoRusso P, Berlin J, Das S. Phase Ia/Ib Study of BAY1895344 Plus Topoisomerase I Inhibitors with a Focus on Poorly Differentiated Neuroendocrine Carcinomas and Pancreatic Adenocarcinoma. Endocrine Abstracts 2023 DOI: 10.1530/endoabs.89.t1.
- Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Gounder M, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2023, 41: 543-543. DOI: 10.1200/jco.2023.41.4_suppl.543.
- Tolcher A, Park W, Wang J, Spira A, Janne P, Lee H, Gill S, LoRusso P, Herzberg B, Goldman J, Morgensztern D, Berlin J, Kasi A, Fujii H, Pelster M. Trial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations. Journal Of Clinical Oncology 2023, 41: tps764-tps764. DOI: 10.1200/jco.2023.41.4_suppl.tps764.
- Gounder M, Bauer T, Schwartz G, Weise A, LoRusso P, Kumar P, Tao B, Hong Y, Patel P, Lu Y, Lesegretain A, Tirunagaru V, Xu F, Doebele R, Hong D. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas. Journal Of Clinical Oncology 2023, 41: 1714-1724. PMID: 36669146, PMCID: PMC10022862, DOI: 10.1200/jco.22.01285.
- Budhraja K, McDonald B, Stephens M, Contente-Cuomo T, Markus H, Farooq M, Favaro P, Connor S, Byron S, Egan J, Ernst B, McDaniel T, Sekulic A, Tran N, Prados M, Borad M, Berens M, Pockaj B, LoRusso P, Bryce A, Trent J, Murtaza M. Genome-wide analysis of aberrant position and sequence of plasma DNA fragment ends in patients with cancer. Science Translational Medicine 2023, 15: eabm6863. PMID: 36630480, PMCID: PMC10080578, DOI: 10.1126/scitranslmed.abm6863.
- Bakouny Z, Labaki C, Grover P, Awosika J, Gulati S, Hsu C, Alimohamed S, Bashir B, Berg S, Bilen M, Bowles D, Castellano C, Desai A, Elkrief A, Eton O, Fecher L, Flora D, Galsky M, Gatti-Mays M, Gesenhues A, Glover M, Gopalakrishnan D, Gupta S, Halfdanarson T, Hayes-Lattin B, Hendawi M, Hsu E, Hwang C, Jandarov R, Jani C, Johnson D, Joshi M, Khan H, Khan S, Knox N, Koshkin V, Kulkarni A, Kwon D, Matar S, McKay R, Mishra S, Moria F, Nizam A, Nock N, Nonato T, Panasci J, Pomerantz L, Portuguese A, Provenzano D, Puc M, Rao Y, Rhodes T, Riely G, Ripp J, Rivera A, Ruiz-Garcia E, Schmidt A, Schoenfeld A, Schwartz G, Shah S, Shaya J, Subbiah S, Tachiki L, Tucker M, Valdez-Reyes M, Weissmann L, Wotman M, Wulff-Burchfield E, Xie Z, Yang Y, Thompson M, Shah D, Warner J, Shyr Y, Choueiri T, Wise-Draper T, Fromowitz A, Gandhi R, Gartrell B, Goel S, Halmos B, Makower D, O' Sullivan D, Ohri N, Portes M, Shapiro L, Shastri A, Sica R, Verma A, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Stockerl-Goldstein K, Zhou A, Bitran J, Hallmeyer S, Mundt D, Pandravada S, Papaioannou P, Patel M, Streckfuss M, Tadesse E, Gatson N, Kundranda M, Lammers P, Loree J, Yu I, Bindal P, Lam B, Peters M, Piper-Vallillo A, Egan P, Farmakiotis D, Arvanitis P, Klein E, Olszewski A, Vieira K, Angevine A, Bar M, Del Prete S, Fiebach M, Gulati A, Hatton E, Houston K, Rose S, Steve Lo K, Stratton J, Weinstein P, Garcia J, Routy B, Hoyo-Ulloa I, Dawsey S, Lemmon C, Pennell N, Sharifi N, Painter C, Granada C, Hoppenot C, Li A, Bitterman D, Connors J, Demetri G, Florez (Duma) N, Freeman D, Giordano A, Morgans A, Nohria A, Saliby R, Tolaney S, Van Allen E, Xu W, Zon R, Halabi S, Zhang T, Dzimitrowicz H, Leighton J, Graber J, Grivas P, Hawley J, Loggers E, Lyman G, Lynch R, Nakasone E, Schweizer M, Vinayak S, Wagner M, Yeh A, Dansoa Y, Makary M, Manikowski J, Vadakara J, Yossef K, Beckerman J, Goyal S, Messing I, Rosenstein L, Steffes D, Alsamarai S, Clement J, Cosin J, Daher A, Dailey M, Elias R, Fein J, Hosmer W, Jayaraj A, Mather J, Menendez A, Nadkarni R, Serrano O, Yu P, Balanchivadze N, Gadgeel S, Accordino M, Bhutani D, Bodin B, Hershman D, Masson C, Alexander M, Mushtaq S, Reuben D, Bernicker E, Deeken J, Jeffords K, Shafer D, Cárdenas A, Cuervo Campos R, De-la-Rosa-Martinez D, Ramirez A, Vilar-Compte D, Gill D, Lewis M, Low C, Jones M, Mansoor A, Mashru S, Werner M, Cohen A, McWeeney S, Nemecek E, Williamson S, Peters S, Smith S, Lewis G, Zaren H, Akhtari M, Castillo D, Cortez K, Lau E, Nagaraj G, Park K, Reeves M, O'Connor T, Altman J, Gurley M, Mulcahy M, Wehbe F, Durbin E, Nelson H, Ramesh V, Sachs Z, Wilson G, Bardia A, Boland G, Gainor J, Peppercorn J, Reynolds K, Rosovsky R, Zubiri L, Bekaii-Saab T, Joyner M, Riaz I, Senefeld J, Shah S, Ayre S, Bonnen M, Mahadevan D, McKeown C, Mesa R, Ramirez A, Salazar M, Shah P, Wang C, Bouganim N, Papenburg J, Sabbah A, Tagalakis V, Vinh D, Nanchal R, Singh H, Bahadur N, Bao T, Belenkaya R, Nambiar P, O’Cearbhaill R, Papadopoulos E, Philip J, Robson M, Rosenberg J, Wilkins C, Tamimi R, Cerrone K, Dill J, Faller B, Alomar M, Chandrasekhar S, Hume E, Islam J, Ajmera A, Brouha S, Cabal A, Choi S, Hsiao A, Jiang J, Kligerman S, Park J, Razavi P, Reid E, Bhatt P, Mariano M, Thomson C, Glace M, Knoble J, Rink C, Zacks R, Blau S, Brown C, Cantrell A, Namburi S, Polimera H, Rovito M, Edwin N, Herz K, Kennecke H, Monfared A, Sautter R, Cronin T, Elshoury A, Fleissner B, Griffiths E, Hernandez-Ilizaliturri F, Jain P, Kariapper A, Levine E, Moffitt M, O'Connor T, Smith L, Wicher C, Zsiros E, Jabbour S, Misdary C, Shah M, Batist G, Cook E, Ferrario C, Lau S, Miller W, Rudski L, Santos Dutra M, Wilchesky M, Mahmood S, McNair C, Mico V, Dixon B, Kloecker G, Logan B, Mandapakala C, Cabebe E, Jha A, Khaki A, Nagpal S, Schapira L, Wu J, Whaley D, Lopes G, de Cardenas K, Russell K, Stith B, Taylor S, Klamerus J, Revankar S, Addison D, Chen J, Haynam M, Jhawar S, Karivedu V, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Abbasi S, Annis S, Balmaceda N, Greenland S, Kasi A, Rock C, Luders M, Smits M, Weiss M, Chism D, Owenby S, Ang C, Doroshow D, Metzger M, Berenberg J, Uyehara C, Fazio A, Huber K, Lashley L, Sueyoshi M, Patel K, Riess J, Borno H, Small E, Zhang S, Andermann T, Jensen C, Rubinstein S, Wood W, Ahmad S, Brownfield L, Heilman H, Kharofa J, Latif T, Marcum M, Shaikh H, Sohal D, Abidi M, Geiger C, Markham M, Russ A, Saker H, Acoba J, Choi H, Rho Y, Feldman L, Gantt G, Hoskins K, Khan M, Liu L, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Zakharia Y, Friese C, Boldt A, Gonzalez C, Su C, Su C, Yoon J, Bijjula R, Mavromatis B, Seletyn M, Wood B, Zaman Q, Kaklamani V, Beeghly A, Brown A, Charles L, Cheng A, Crispens M, Croessmann S, Davis E, Ding T, Duda S, Enriquez K, French B, Gillaspie E, Hausrath D, Hennessy C, Lewis J, Li X, Prescott L, Reid S, Saif S, Slosky D, Solorzano C, Sun T, Vega-Luna K, Wang L, Aboulafia D, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Moore J, Rice R, Cabalona W, Cyr S, Barrow McCollough B, Peddi P, Rosen L, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Lustberg M, Masters T, Stratton C. Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19. JAMA Oncology 2023, 9: 128-134. PMID: 36326731, PMCID: PMC9634600, DOI: 10.1001/jamaoncol.2022.5357.
- Papadopoulos K, Li T, Lakhani N, Powderly J, George T, Teoh D, Kilari D, Giaccone G, Sanborn R, Ghamande S, LoRusso P, Gibney G, Ma V, Yalamanchili K, Brown J, Mota N, Kadra C, Umiker B, Xiao X, Trehu E. 172P Phase I study of JTX-8064, a LILRB2 (ILT4) inhibitor, as monotherapy and combination with pimivalimab (pimi), a PD-1 inhibitor (PD-1i), in patients (pts) with advanced solid tumors. Immuno-Oncology Technology 2022, 16: 100284. DOI: 10.1016/j.iotech.2022.100284.
- LoRusso P, Freidlin B. Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials. Journal Of The National Cancer Institute 2022, 115: 122-124. PMID: 36448688, PMCID: PMC9905964, DOI: 10.1093/jnci/djac212.
- Yap T, LoRusso P, Wong D, Hu-Lieskovan S, Papadopoulos K, Holz J, Grabowska U, Gradinaru C, Leung K, Marshall S, Reader C, Russell R, Sainson R, Seal C, Shepherd C, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clinical Cancer Research 2022, 29: 888-898. PMID: 36342102, DOI: 10.1158/1078-0432.ccr-22-1449.
- Tolcher A, Roda-Perez D, He K, Moreno V, Gomez-Roca C, Machiels J, Razak A, Sahtout M, Guan X, Jaryno-Daly S, Leibman R, Blaney M, O’Brien J, Lorusso P, Powderly J, Golan T, Miller K, Bruix J. 770 Safety, efficacy, and pharmacokinetic results from a phase I first-in-human study of ABBV-151 with or without anti-PD1 mAb (budigalimab) in patients with locally advanced or metastatic solid tumors. 2022, a801-a801. DOI: 10.1136/jitc-2022-sitc2022.0770.
- Myint H, Shah S, Gutierrez M, Zsiros E, Nelson M, Zeidan S, Myrthil N, Morawski A, Barbu A, Shaik J, Zhou C, Kanellopoulou C, Copeland R, Cusumano Z, Flies D, Langermann S, Lorusso P, Odunsi K. 748 A phase 1/2, open-label, dose-escalation, safety and tolerability study of NC762 in subjects with advanced or metastatic solid tumors. 2022, a781-a781. DOI: 10.1136/jitc-2022-sitc2022.0748.
- Harrington K, Dowling E, Latek R, Schmohl M, Lorusso P. 626 Trial in progress: an intravenously administered second-generation STING agonist, BI 1703880 with a novel lead-in design in combination with ezabenlimab. 2022, a658-a658. DOI: 10.1136/jitc-2022-sitc2022.0626.
- Rodon J, Chaney M, Cohen J, Garyantes T, Lin J, Lorusso P, Mita A, Mita M, Muller C, Natale C, Orloff M, Papadopoulos K, Patel S. 759 Phase 1b study of LNS8801 in combination with pembrolizumab in patients with secondary resistance to immune checkpoint inhibitors. 2022, a791-a791. DOI: 10.1136/jitc-2022-sitc2022.0759.
- Blanter J, Werner M, Kier M, Hapanowicz O, Itani M, Ahmad M, DeMerchant M, Eder J, Galsky M, Hammad A, King P, Lachowicz M, Lucas N, Marron T, Shelton G, Wu K, Xu S, LoRusso P, Hofstatter E, Doroshow D. Financial toxicity in patients with advanced solid malignancies participating in early-phase clinical trials. Journal Of Clinical Oncology 2022, 40: 267-267. DOI: 10.1200/jco.2022.40.28_suppl.267.
- Sacher A, Patel M, Miller W, Desai J, Garralda E, Bowyer S, Kim T, De Miguel M, Falcon A, Krebs M, Lee J, Cheng M, Han S, Shacham-Shmueli E, Forster M, Jerusalem G, Massarelli E, Rodriguez L, Prenen H, Walpole I, Arbour K, Choi Y, Dharia N, Lin M, Mandlekar S, Joo S, Shi Z, Schutzman J, LoRusso P. OA03.04 Phase I A Study to Evaluate GDC-6036 Monotherapy in Patients with Non-small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation. Journal Of Thoracic Oncology 2022, 17: s8-s9. DOI: 10.1016/j.jtho.2022.07.023.
- Cohen J, Natale C, Lin J, Lorusso P, Mita A, Mita M, Muller C, Orloff M, Papadopoulos K, Rodon J, Garyantes T. 85P A circulating, surrogate-systemic biomarker correlates with anti-tumor benefit on LNS8801 therapy. Annals Of Oncology 2022, 33: s578-s579. DOI: 10.1016/j.annonc.2022.07.117.
- Medina J, Torres E, Leal A, Adleff V, Lumbard K, Keefer L, Carey J, Brufsky A, Lorusso P, Eder J, Chung V, Downs M, O'Connor A, Piekarz R, Streicher H, Jaffee E, Scharpf R, Stearns V, Connolly R, Velculescu V. 1669P Monitoring immune checkpoint inhibition in advanced solid tumors using genome-wide cfDNA fragmentomes. Annals Of Oncology 2022, 33: s1306-s1307. DOI: 10.1016/j.annonc.2022.07.1749.
- Desai J, Han S, Forster M, Kim T, Casal G, Shmueli E, Bowyer S, De Miguel M, Gonzalez A, Jones R, Krebs M, Miller W, Paz-Ares L, Lorusso P, Sacher A, Dharia N, Lin M, Schutzman J, Shi Z, Patel M. 362P Phase Ia study to evaluate GDC-6036 monotherapy in patients with colorectal cancer (CRC) with KRAS G12C mutation. Annals Of Oncology 2022, 33: s701-s702. DOI: 10.1016/j.annonc.2022.07.500.
- Schoeffski P, Yamamoto N, Bauer T, Patel M, Gounder M, Geng J, Sailer R, Jayadeva G, Lorusso P. 452O A phase I dose-escalation and expansion study evaluating the safety and efficacy of the MDM2–p53 antagonist BI 907828 in patients (pts) with solid tumours. Annals Of Oncology 2022, 33: s743. DOI: 10.1016/j.annonc.2022.07.581.
- Patel M, Lee J, De Miguel M, Burns T, Gonzalez A, Kim T, Krebs M, Prenen H, Shmueli E, Desai J, Lorusso P, Sacher A, Choi Y, Dharia N, Lin M, Mandlekar S, Royer-Joo S, Schutzman J, Garralda E. 459MO Phase Ia study to evaluate GDC-6036 monotherapy in patients with solid tumors with a KRAS G12C mutation. Annals Of Oncology 2022, 33: s749. DOI: 10.1016/j.annonc.2022.07.588.
- Champiat S, Wermke M, Vicier C, de Bono J, Jungels C, Vey N, Kotecki N, Wetzko K, Ruhnke L, Garralda E, de Aguiar V, Lorusso P, de Gassart A, Valentin E, Brune P, Iche M, Leparquier C, Olive D, Marabelle A, Frohna P. 732MO The combination of ICT01, a γ9δ2 T cell-activating mAb, plus pembrolizumab induces a broad antitumor immune response and disease control in patients with CPI-failure melanoma, NSCLC and bladder cancer: EVICTION trial. Annals Of Oncology 2022, 33: s877-s878. DOI: 10.1016/j.annonc.2022.07.858.
- Garralda E, Naing A, Galvao V, LoRusso P, Grell P, Cassier P, Gomez-Roca C, Korakis I, Bechard D, Jelinkova L, Adkins I, Tillmanns S, Kiemle-Kallee J, Marabelle A, Champiat S. Interim safety and efficacy results from AURELIO-03: A phase 1 dose escalation study of the IL-2/IL-15 receptor βγ superagonist SOT101 as a single agent and in combination with pembrolizumab in patients with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 2502-2502. DOI: 10.1200/jco.2022.40.16_suppl.2502.
- Falchook G, Ribas A, Davar D, Eroglu Z, Wang J, Luke J, Hamilton E, Di Pace B, Wang T, Ghosh S, Dhar A, Borgovan T, Waszak A, LoRusso P. Phase 1 trial of TIM-3 inhibitor cobolimab monotherapy and in combination with PD-1 inhibitors nivolumab or dostarlimab (AMBER). Journal Of Clinical Oncology 2022, 40: 2504-2504. DOI: 10.1200/jco.2022.40.16_suppl.2504.
- Goel S, Ulahannan S, Olszanski A, LoRusso P, Sanborn R, Sharma S, Emens L, Reilley M, Priego V, Li S, Wang B, Dong L, Sachsenmeier K, Gibbs J, Gharavi R, Martinez A, Proscurshim I, Fram R, Gomez-Pinillos A, Rasco D. A phase 1b, multicenter, dose-escalation study of subasumstat (TAK-981) in combination with pembrolizumab in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 2506-2506. DOI: 10.1200/jco.2022.40.16_suppl.2506.
- Muller C, Chaney M, Cohen J, Garyantes T, Lin J, LoRusso P, Mita A, Mita M, Natale C, Orloff M, Papadopoulos K, Patel S, Ahnert J. Phase 1b study of the novel first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-relapsed and refractory solid malignancies and dose escalation update. Journal Of Clinical Oncology 2022, 40: 2574-2574. DOI: 10.1200/jco.2022.40.16_suppl.2574.
- Gounder M, Yamamoto N, Patel M, Bauer T, Schöffski P, Grempler R, Durland-Busbice S, Geng J, Maerten A, LoRusso P. A phase Ia/Ib, dose-escalation/expansion study of the MDM2–p53 antagonist BI 907828 in patients with solid tumors, including advanced/metastatic liposarcoma (LPS). Journal Of Clinical Oncology 2022, 40: 3004-3004. DOI: 10.1200/jco.2022.40.16_suppl.3004.
- Villaruz L, Kelly K, Waqar S, Davis E, Shapiro G, LoRusso P, Dees E, Normolle D, Rhee J, Chu E, Gore S, Beumer J. NCI 9938: Phase I clinical trial of ATR inhibitor berzosertib (M6620, VX-970) in combination with irinotecan in patients with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 3012-3012. DOI: 10.1200/jco.2022.40.16_suppl.3012.
- LoRusso P, Rasco D, Shapiro G, Mita A, Azad N, Swiecicki P, El-Khoueiry A, Gandara D, Kummar S, Tanajian H, Taylor J, Bottone F, Toguchi M, Hindley C, Chan D, Oganesian A, Keer H, Dao K, Sullivan R, Spira A. A first-in-human, phase 1 study of ASTX029, a dual-mechanism inhibitor of ERK1/2, in relapsed/refractory solid tumors. Journal Of Clinical Oncology 2022, 40: 9085-9085. DOI: 10.1200/jco.2022.40.16_suppl.9085.
- Lakhani N, Friedman C, Perez C, Wehr A, McGoldrick S, LoRusso P. Phase 1 study of SGN-ALPV, a novel, investigational vedotin antibody–drug conjugate directed to ALPP/ALPPL2 in advanced solid tumors (SGNALPV-001, trial in progress). Journal Of Clinical Oncology 2022, 40: tps3159-tps3159. DOI: 10.1200/jco.2022.40.16_suppl.tps3159.
- Fanucci K, Pilat M, Shah R, Boerner S, Li J, Durecki D, Drappatz J, Collichio F, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Bao X, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma. Journal Of Clinical Oncology 2022, 40: 2035-2035. DOI: 10.1200/jco.2022.40.16_suppl.2035.
- Yap TA, Gainor JF, Callahan MK, Falchook GS, Pachynski RK, LoRusso P, Kummar S, Gibney GT, Burris HA, Tykodi SS, Rahma OE, Seiwert TY, Papadopoulos KP, Murphy M, Park H, Hanson A, Hashambhoy-Ramsay Y, McGrath L, Hooper E, Xiao X, Cohen H, Fan M, Felitsky D, Hart C, McComb R, Brown K, Sepahi A, Jimenez J, Zhang W, Baeck J, Laken H, Murray R, Trehu E, Harvey CJ. First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response. Clinical Cancer Research 2022, 28: 3695-3708. PMID: 35511938, PMCID: PMC9433959, DOI: 10.1158/1078-0432.ccr-21-4256.
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- Chung H, Lee K, Kim W, Gainor J, Lakhani N, Chow L, Messersmith W, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, LoRusso P. SO-31 ASPEN-01: A phase 1 study of ALX148, a CD47 blocker, in combination with trastuzumab, ramucirumab and paclitaxel in patients with second-line HER2-positive advanced gastric or gastroesophageal junction cancer. Annals Of Oncology 2021, 32: s215-s216. DOI: 10.1016/j.annonc.2021.05.055.
- Melero I, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso P, Tureci O, Niewood M, Sahin U, Jure-Kunkel M, Forssmann U, Ahmadi T, Alonso G. MO24-1 Phase I/IIa trial evaluating safety and clinical activity of DuoBody®-PD-L1×4-1BB (GEN1046) in advanced solid tumors. Annals Of Oncology 2021, 32: s313. DOI: 10.1016/j.annonc.2021.05.625.
- Thompson M, Henderson J, Shah P, Rubinstein S, Joyner M, Choueiri T, Flora D, Griffiths E, Gulati A, Hwang C, Koshkin V, Papadopoulos E, Robilotti E, Su C, Wulff-Burchfield E, Xie Z, Yu P, Mishra S, Senefeld J, Shah D, Warner J, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Monahan R, Zhou A, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Revankar S, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Angevine A, Bar M, Lo K, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Nizam A, Lemmon C, Hoppenot C, Li A, Bakouny Z, Bouchard G, Busser F, Conners J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Schmidt A, Shaw G, Van Allen E, Nuzzo P, Xu W, Zon R, Zhang T, Halabi S, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Gatson N, Goyal S, Huynh-Le M, Rosenstein L, Clement J, Daher A, Dailey M, Elias R, Hsu E, Menendez A, Rathmann J, Serrano O, Jayaraj A, Gadgeel S, Hawley J, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Nagle S, Hayes-Lattin B, McWeeney S, Nemecek E, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Belenkaya R, Philip J, Riely G, Faller B, McKay R, Ajmera A, Cabal A, Shaya J, Weissmann L, Jani C, Chen J, Gatti-Mays M, Jhawar S, Lustberg M, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Karivedu V, Addison D, Joshi M, Menon H, Rovito M, Elshoury A, Jabbour S, Shah M, Bashir B, Mahmood S, McNair C, Mico V, Rivera A, Miller C, Cabebe E, Glover M, Jha A, Schapira L, Shah S, Wu J, Subbiah S, Logan B, Kloecker G, Lopes G, Russell K, Stith B, Smits M, Edwin N, Chism D, Owenby S, Doroshow D, Galsky M, Zhu H, Fu J, Fazio A, Patel K, Riess J, Kwon D, Kumar V, Islam J, Wood W, Ahmad S, Grover P, Gulati S, Kharofa J, Marcum M, Park C, Wise-Draper T, Bowles D, Geiger C, Bishnoi R, Markham M, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Khan M, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Kasi A, Fecher L, Friese C, Mavromatis B, Zaman Q, Bijjula R, Cheng A, Davis E, French B, Gillaspie E, Hausrath D, Hennessy C, Hsu C, Johnson D, Li X, Reid S, Rini B, Shyr Y, Slosky D, Solorzano C, Tucker M, Vega-Luna K, Wang L, Enriquez K, Sun T, Carducci T, Puc M, Van Loon S, Goldsmith K, Rice R, Cabalona W, Pilar C, Barrow McCollough B, Peddi P, Rosen L, Bilen M, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C. Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19. JAMA Oncology 2021, 7: 1167-1175. PMID: 34137799, PMCID: PMC8377563, DOI: 10.1001/jamaoncol.2021.1799.
- Roussos Torres ET, Rafie C, Wang C, Lim D, Brufsky A, LoRusso P, Eder JP, Chung V, Downs M, Geare M, Piekarz R, Streicher H, Anforth L, Rudek MA, Zhu Q, Besharati S, Cimino-Mathews A, Anders RA, Stearns V, Jaffee EM, Connolly RM. Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844). Clinical Cancer Research 2021, 27: clincanres.5017.2021. PMID: 34135021, PMCID: PMC8563383, DOI: 10.1158/1078-0432.ccr-20-5017.
- Halperin RF, Hegde A, Lang JD, Raupach EA, Legendre C, Liang W, LoRusso P, Sekulic A, Sosman J, Trent J, Rangasamy S, Pirrotte P, Schork N. Improved methods for RNAseq-based alternative splicing analysis. Scientific Reports 2021, 11: 10740. PMID: 34031440, PMCID: PMC8144374, DOI: 10.1038/s41598-021-89938-2.
- Puzanov I, LoRusso P, Papadopoulos K, Chen C, LeBruchec Y, He X, Cousin T, Havenith K, Boni J, Bendell J. A phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 2556-2556. DOI: 10.1200/jco.2021.39.15_suppl.2556.
- Tolcher A, Carneiro B, Dowlati A, Razak A, Chae Y, Villella J, Coppola S, Englert S, Phillips A, Souers A, Salman Z, Penugonda S, Powderly J, LoRusso P. A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results. Journal Of Clinical Oncology 2021, 39: 3015-3015. DOI: 10.1200/jco.2021.39.15_suppl.3015.
- LoRusso P, Gounder M, Patel M, Yamamoto N, Bauer T, Laurie S, Grempler R, Davenport T, Geng J, Rohrbacher M, Lahmar M. A phase I dose-escalation study of the MDM2-p53 antagonist BI 907828 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2021, 39: 3016-3016. DOI: 10.1200/jco.2021.39.15_suppl.3016.
- Muller C, Brown-Glaberman U, Chaney M, Garyantes T, LoRusso P, McQuade J, Mita A, Mita M, Natale C, Orloff M, Papadopoulos K, Sato T, Yilmaz E, Rodon J. Phase 1 trial of a novel, first-in-class G protein-coupled estrogen receptor (GPER) agonist, LNS8801, in patients with advanced or recurrent treatment-refractory solid malignancies. Journal Of Clinical Oncology 2021, 39: 3084-3084. DOI: 10.1200/jco.2021.39.15_suppl.3084.
- Schram A, Ahnert J, Patel M, Jauhari S, Sachdev J, Zhu V, LoRusso P, Nguyen D, Le X, O'Connor M, Waters N, Cook C, Witt K, Humphrey R, Janne P, Hamilton E. Safety and preliminary efficacy from the phase 1 portion of MasterKey-01: A First-in-human dose-escalation study to determine the recommended phase 2 dose (RP2D), pharmacokinetics (PK) and preliminary antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients (pts) with advanced solid malignancies. Journal Of Clinical Oncology 2021, 39: 3086-3086. DOI: 10.1200/jco.2021.39.15_suppl.3086.
- Waters N, Patel M, Schram A, Ahnert J, Jauhari S, Sachdev J, Zhu V, LoRusso P, Nguyen D, Hong D, Tarilonte L, Humphrey R, Janne P, Hamilton E, Witt K. Clinical pharmacokinetics of bdtx-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies in MasterKey-01 study. Journal Of Clinical Oncology 2021, 39: 3097-3097. DOI: 10.1200/jco.2021.39.15_suppl.3097.
- Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Wu K, Patel S. Safety and efficacy of the anti-CD73 monoclonal antibody (mAb) oleclumab ± durvalumab in patients (pts) with advanced colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), or EGFR-mutant non-small cell lung cancer (EGFRm NSCLC). Journal Of Clinical Oncology 2021, 39: 9047-9047. DOI: 10.1200/jco.2021.39.15_suppl.9047.
- Falchook G, Luke J, Strauss J, Gao X, LoRusso P, VOON P, Li C, Shaw M, Gregory R, Horn K, Gibbs J, Lineberry N, Stumpo K, Malek K, Olszanski A. A phase 1 dose-escalation study of intravenously (IV) administered TAK-676, a novel STING agonist, alone and in combination with pembrolizumab in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2021, 39: tps2670-tps2670. DOI: 10.1200/jco.2021.39.15_suppl.tps2670.
- Yee D, LoRusso P, Sablin M, Prat A, Stradella A, Utriainen M, Oliveira M, Yonemori K, Naito Y, Hardebeck M, Puig M, Hu J, Biyukov T, Iwata H. A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+), HER2-negative breast cancer (BC) with visceral or non-visceral disease. Journal Of Clinical Oncology 2021, 39: 1057-1057. DOI: 10.1200/jco.2021.39.15_suppl.1057.
- Kim J, Cardin DB, Vaishampayan UN, Kato S, Grossman SR, Glazer P, Shyr Y, Ivy SP, LoRusso P. Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. The Oncologist 2021, 26: e1104-e1109. PMID: 33742489, PMCID: PMC8265343, DOI: 10.1002/onco.13758.
- Shaya J, Xie W, Saraiya B, Parikh M, Folefac E, Olson A, Choudhury A, Einstein D, Heath E, Parikh R, Kunos C, Ivy S, LoRusso P, Kurzrock R, Shapiro G, McKay R. A phase I/II study of combination olaparib and radium-223 in men with metastatic castration-resistant prostate cancer with bone metastases (COMRADE): A trial in progress. Journal Of Clinical Oncology 2021, 39: tps182-tps182. DOI: 10.1200/jco.2021.39.6_suppl.tps182.
- Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.
- Yap T, Wong D, Hu-Lieskovan S, Papadopoulos K, Morrow M, Grabowska U, Gliddon D, Holz J, LoRusso P. 395 A first-in-human study of FS118, a tetravalent bispecific antibody targeting LAG-3 and PD-L1, in patients with advanced cancer and resistance to PD-(L)1 therapy. 2020, a240-a240. DOI: 10.1136/jitc-2020-sitc2020.0395.
- Marabelle A, Champiat S, Garralda E, Hernando A, Janku F, Raina A, Sachse R, Bechard D, Krasnopolskaya I, Ferrara S, LoRusso P. 807 A multicenter open-label phase I/lb study of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors. 2020, a483.1-a483. DOI: 10.1136/jitc-2020-sitc2020.0807.
- Lee K, Chung H, Kim W, Chow L, Lakhani N, Messersmith W, Bang Y, LoRusso P, Fanning P, Squifflet P, Jin F, Forgie A, Wan H, Pons J, Randolph S, Gainor J. 404 ALX148, a CD47 blocker, in combination with standard chemotherapy and antibody regimens in patients with gastric/gastroesophageal junction (GC) cancer and head and neck squamous cell carcinoma (HNSCC). 2020, a245.2-a246. DOI: 10.1136/jitc-2020-sitc2020.0404.
- Garralda E, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso P, Türeci Ö, Niewood M, Şahin U, Jure-Kunkel M, Forssmann U, Ahmadi T, Melero I. 412 First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD-L1×4–1BB (GEN1046) in patients with advanced solid tumors. Journal For ImmunoTherapy Of Cancer 2020, 8: a250-a251. DOI: 10.1136/jitc-2020-sitc2020.0412.
- Abidi M, Aboulafia D, Accordino M, Acoba J, Ahluwalia M, Ahmad S, Ajmera A, Alimohamed S, Altman J, Angevine A, Bakouny Z, Bar M, Bardia A, Barnholtz-Sloan J, Barrow McCollough B, Bashir B, Batist G, Bekaii-Saab T, Berg S, Bernicker E, Bhutani D, Bilen M, Bindal P, Bishnoi R, Blau S, Bohachek P, Boland G, Bonnen M, Bouchard G, Bouganim N, Bowles D, Busser F, Butt O, Cabal A, Cabalona W, Cabebe E, Caimi P, Campian J, Carducci T, Chen J, Cheng A, Chism D, Choueiri T, Clark M, Clement J, Connors J, Cook E, Curran C, Daher A, Dailey M, Davis E, Dawsey S, Deeken J, Del Prete S, Demetri G, Desai A, Doroshow D, Durbin E, Egan P, Elias R, Elkrief A, Elms D, Elshoury A, Faller B, Farmakiotis D, Fecher L, Feldman L, Ferrario C, Fiala M, Flora D, French B, Friese C, Fu J, Gadgeel S, Gainor J, Galsky M, Gantt G, Garcia J, Gartrell B, Gatti-Mays M, Gill D, Gillaspie E, Giordano A, Glace (, Glover M, Goel S, Graber J, Griffiths E, Grivas P, Grover P, Gulati A, Gulati S, Gupta S, Gurley M, Hafez N, Halabi S, Halfdanarson T, Halmos B, Hausrath D, Hawley J, Hennessy C, Herbst R, Hershman D, Hoppenot C, Hoskins K, Hoyo-Ulloa I, Hsu E, Hsu C, Hwang C, Islam J, Jabbour S, Jani C, Jha A, Jhawar S, Johnson D, Joshi M, Kasi A, Kelleher K, Kennecke H, Khaki A, Khan H, Khan M, Kharofa J, Kloecker G, Knoble J, Kulkarni A, Kumar V, Lammers P, Leighton J, Lemmon C, Lewis M, Li A, Li X, Liu S, Lo K, Loaiza-Bonilla A, Logan B, Loggers E, de Lima Lopes G, Loree J, LoRusso P, Low C, Lustberg M, Lyman G, Lynch R, Madhavan S, Mahadevan D, Mahmood S, Mansoor A, Marcum M, Markham M, Mashru S, Masters T, Mavromatis B, McKay R, McNair C, McWeeney S, Menendez A, Menon H, Mesa R, Mico V, Miller C, Mishra S, Monahan R, Morgans A, Mulcahy M, Mundt D, Mushtaq S, Nagaraj G, Nagle S, Nakasone E, Nakayama J, Nelson H, Nemecek E, Nguyen R, Nizam A, Nohria A, Nuzzo P, Ohri N, Olszewski A, Owenby S, Painter C, Palmer J, Panagiotou O, Park C, Pasquinelli M, Patel J, Patel K, Peddi P, Pennell N, Peters S, Pilar C, Pillainayagam C, Puc M, Ramirez A, Rathmann J, Ravindranathan D, Reid S, Reuben D, Revankar S, Reynolds K, Rho Y, Rhodes T, Rice R, Riess J, Rini B, Rink C, Rosen L, Rosenstein L, Rosovsky R, Routy B, Rovito M, Rubinstein S, Saif M, Salazar M, Santos Dutra M, Schapira L, Schmidt A, Schroeder B, Schwartz G, Schwartz C, Schweizer M, Serrano O, Shafer D, Shah P, Shah D, Shah M, Shah S, Shah C, Shaw G, Shaya J, Shyr Y, Slosky D, Smits M, Solorzano C, Stauffer K, Stockerl-Goldstein K, Stover D, Stratton J, Stratton C, Streckfuss M, Subbiah S, Tachiki L, Tadesse E, Thompson M, Topaloglu U, Tucker M, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Vinayak S, Vinh D, Wagner M, Wall S, Wang L, Warner J, Wehbe F, Weinstein P, Weiss M, Weissmann L, Wildes T, Williams N, Wise-Draper T, Wood W, Wu J, Wulff-Burchfield E, Xie Z, Xu W, Yeh A, Yu I, Yu P, Zacks R, Zaman Q, Zaren H, Zhang T, Zhou A, Zhu H, Zon R, Zubiri L. A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19:CCC19 Governance, Protocol, and Quality Assurance. Cancer Cell 2020, 38: 761-766. PMID: 33176160, PMCID: PMC7598547, DOI: 10.1016/j.ccell.2020.10.022.
- Gounder M, Bauer T, Schwartz G, LoRusso P, Kumar P, Kato K, Tao B, Hong Y, Patel P, Hong D. 7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas. European Journal Of Cancer 2020, 138: s3-s4. DOI: 10.1016/s0959-8049(20)31080-7.
- Hong D, Marcelo-Lewis K, LoRusso P. Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center. 2020, 71-83. DOI: 10.1007/978-3-030-47682-3_4.
- Powderly J, Shimizu T, Lorusso P, Razak A, Miller K, Balar A, Bruix J, Michel L, Blaney M, Guan X, Lacy S, Lally S, Lambert S, Leibman R, Vosganian G, Golan T, Tolcher A. Phase I first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumours. Annals Of Oncology 2020, 31: s499. DOI: 10.1016/j.annonc.2020.08.710.
- LoRusso P, Fakih M, De Vos F, Beck J, Merchan J, Shapiro G, Lin C, Desai J, Spratlin J, Cascella T, Sandalic L, Abdelhady A, Boran A, Gasal E, Janku F, Van Cutsem E. Phase Ib study of ribociclib (R) + trametinib (T) in patients (pts) with metastatic/advanced solid tumours. Annals Of Oncology 2020, 31: s484. DOI: 10.1016/j.annonc.2020.08.675.
- Puzanov I, Havenith K, Boni J, Cruz H, Anderson K, Kopotsha T, Le Bruchec Y, Bendell J, Kummar S, Papadopoulos K, LoRusso P, Wuerthner J. First-in-human study of camidanlumab tesirine (ADCT-301, Cami), an anti-CD25 targeted therapy in patients (pts) with advanced solid tumours: Pharmacokinetics (PK) and biomarker evaluation. Annals Of Oncology 2020, 31: s710-s711. DOI: 10.1016/j.annonc.2020.08.1150.
- Carducci M, Wang D, Habermehl C, Bödding M, Rohdich F, Stinchi S, Karpenko O, Gimmi C, LoRusso P. A multicenter, open-label, dose-escalation, first-in-man study of MetAP2 inhibitor M8891 in patients with advanced solid tumours. Annals Of Oncology 2020, 31: s486. DOI: 10.1016/j.annonc.2020.08.680.
- Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Hoberman M, Mughal T, Bauer T. Updated results of a phase I study of Felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in patients with relapsed/refractory solid tumours. Annals Of Oncology 2020, 31: s485-s486. DOI: 10.1016/j.annonc.2020.08.678.
- Ahn M, Niu J, Kim D, Rasco D, Mileham K, Chung H, Vaishampayan U, Maurice-Dror C, Russo P, Golan T, Chartash E, Chen D, Healy J, Rajasagi M, Lee D. Vibostolimab, an anti-TIGIT antibody, as monotherapy and in combination with pembrolizumab in anti-PD-1/PD-L1-refractory NSCLC. Annals Of Oncology 2020, 31: s887. DOI: 10.1016/j.annonc.2020.08.1714.
- Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL, Consortium C, Abidi M, Acoba J, Agarwal N, Ahmad S, Ajmera A, Altman J, Angevine A, Azad N, Bar M, Bardia A, Barnholtz-Sloan J, Barrow B, Bashir B, Belenkaya R, Berg S, Bernicker E, Bestvina C, Bishnoi R, Boland G, Bonnen M, Bouchard G, Bowles D, Busser F, Cabal A, Caimi P, Carducci T, Casulo C, Chen J, Clement J, Chism D, Cook E, Curran C, Daher A, Dailey M, Dahiya S, Deeken J, Demetri G, DiLullo S, Duma N, Elias R, Faller B, Fecher L, Feldman L, Friese C, Fu P, Fu J, Futreal A, Gainor J, Garcia J, Gill D, Gillaspie E, Giordano A, Glace G, Grothey A, Gulati S, Gurley M, Halmos B, Herbst R, Hershman D, Hoskins K, Jain R, Jabbour S, Jha A, Johnson D, Joshi M, Kelleher K, Kharofa J, Khan H, Knoble J, Koshkin V, Kulkarni A, Lammers P, Leighton J, Lewis M, Li X, Li A, Lo K, Loaiza-Bonilla A, LoRusso P, Low C, Lustberg M, Mahadevan D, Mansoor A, Marcum M, Markham M, Marshall C, Mashru S, Matar S, McNair C, McWeeney S, Mehnert J, Menendez A, Menon H, Messmer M, Monahan R, Mushtaq S, Nagaraj G, Nagle S, Naidoo J, Nakayama J, Narayan V, Nelson H, Nemecek E, Nguyen R, Nuzzo P, Oberstein P, Olszewski A, Owenby S, Pasquinelli M, Philip J, Prabhakaran S, Puc M, Ramirez A, Rathmann J, Revankar S, Rho Y, Rhodes T, Rice R, Riely G, Riess J, Rink C, Robilotti E, Rosenstein L, Routy B, Rovito M, Saif M, Sanyal A, Schapira L, Schwartz C, Serrano O, Shah M, Shah C, Shaw G, Shergill A, Shouse G, Soares H, Solorzano C, Srivastava P, Stauffer K, Stover D, Stratton J, Stratton C, Subbiah V, Tamimi R, Tannir N, Topaloglu U, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Wall S, Weinstein P, Weiss M, Wise-Draper T, Wood W, Xu W, Yackzan S, Zacks R, Zhang T, Zimmer A, West J. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. The Lancet 2020, 395: 1907-1918. PMID: 32473681, PMCID: PMC7255743, DOI: 10.1016/s0140-6736(20)31187-9.
- Thistlethwaite F, Naing A, Gil-Martin M, LoRusso P, Randhawa M, Eskens F, Sanborn R, Uboha N, Cho D, Spira A, Bondarenko I, Plummer E, Garcia-Corbacho J, Victoria I, Lavernia J, Melero I, De Vries E, Garner W, Arkenau H, Bendell J. PROCLAIM-CX-072: Analysis of patients with advanced solid tumors receiving long-term treatment with CX-072, a PD-L1 probody therapeutic, as a single agent or in combination with ipilimumab. Journal Of Clinical Oncology 2020, 38: 3005-3005. DOI: 10.1200/jco.2020.38.15_suppl.3005.
- Chow L, Gainor J, Lakhani N, Lee K, Chung H, Lee J, LoRusso P, Bang Y, Hodi F, Santana-Davila R, Fanning P, Squifflet P, Jin F, Wan H, Kuo T, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with standard anticancer antibodies and chemotherapy regimens in patients with advanced malignancy. Journal Of Clinical Oncology 2020, 38: 3056-3056. DOI: 10.1200/jco.2020.38.15_suppl.3056.
- Patel M, Bauer T, Jimeno A, Wang D, LoRusso P, Do K, Stemmer S, Maurice-Dror C, Geva R, Zacharek S, Laino A, Sun J, Frederick J, Zhou H, Randolph W, Cohen P, Meehan R, Sullivan R. A phase I study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L, IL-23, and IL-36γ, for intratumoral (iTu) injection alone and in combination with durvalumab. Journal Of Clinical Oncology 2020, 38: 3092-3092. DOI: 10.1200/jco.2020.38.15_suppl.3092.
- Boni V, Burris III H, Liu J, Spira A, Arkenau H, Fidler M, Rosen L, Sweis R, Uboha N, Sanborn R, O'Neil B, Harding J, LoRusso P, Weise A, Garcia-Corbacho J, Victoria I, Frye J, Li R, Stroh M, Meric-Bernstam F. CX-2009, a CD166-directed probody drug conjugate (PDC): Results from the first-in-human study in patients (Pts) with advanced cancer including breast cancer (BC). Journal Of Clinical Oncology 2020, 38: 526-526. DOI: 10.1200/jco.2020.38.15_suppl.526.
- Motwani M, Modi D, Penugonda S, Zhang C, Palma J, Cunningham A, Calvo E, de Jonge M, LoRusso P. Pharmacodynamic effects in blood and tumor tissue of eftozanermin alfa, a tumor necrosis factor-related apoptosis-inducing ligand receptor agonist. Journal Of Clinical Oncology 2020, 38: e15668-e15668. DOI: 10.1200/jco.2020.38.15_suppl.e15668.
- Powderly J, Tolcher A, LoRusso P, Blaney M, Dacosta D, Henner W, McDevitt M, Miller K, Golan T. A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors. Journal Of Clinical Oncology 2020, 38: tps3147-tps3147. DOI: 10.1200/jco.2020.38.15_suppl.tps3147.
- Powderly J, Chmielowski B, Brahmer J, Piha-Paul S, Bowyer S, LoRusso P, Catenacci D, Wu C, Barve M, Chisamore M, Nasrah N, Johnson D, Ho W. Phase I/II dose-escalation and expansion study of FLX475 alone and in combination with pembrolizumab in advanced cancer. Journal Of Clinical Oncology 2020, 38: tps3163-tps3163. DOI: 10.1200/jco.2020.38.15_suppl.tps3163.
- Hamilton E, Patel M, Rodon J, Hong D, Schram A, Janne P, LoRusso P, Sachdev J, Ou S, Buck E, O'Connor M, Waters N, Witt K, Cook C. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. Journal Of Clinical Oncology 2020, 38: tps3665-tps3665. DOI: 10.1200/jco.2020.38.15_suppl.tps3665.
- Gutierrez M, Hamid O, Shum E, Wise D, Balar A, Weber J, LoRusso P, Shafi S, Rimm D, Tolcher A, Basudhar D, Dujka M, Heller K. Trial in progress: A phase I/II, open-label, dose-escalation, safety and tolerability study of NC318 in subjects with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2020, 38: tps3166-tps3166. DOI: 10.1200/jco.2020.38.15_suppl.tps3166.
- LoRusso P, Pilat M, Santa-Maria C, Connolly R, Roesch E, Afghahi A, Han H, Nanda R, Wulf G, Assad H, Park H, Dees E, Force J, Noonan A, Brufsky A, Abramson V, Haley B, Buys S, Sharon E, Schalper K. Trial in progress: A phase II open-label, randomized study of PARP inhibition (olaparib) either alone or in combination with anti-PD-L1 therapy (atezolizumab) in homologous DNA repair (HDR) deficient, locally advanced or metastatic non-HER2-positive breast cancer. Journal Of Clinical Oncology 2020, 38: tps1102-tps1102. DOI: 10.1200/jco.2020.38.15_suppl.tps1102.
- Strickler JH, LoRusso P, Salgia R, Kang YK, Yen C, Lin CC, Ansell P, Motwani M, Wong S, Yue H, Wang L, Reilly E, Afar D, Naumovski L, Ramanathan RK. Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2020, 19: 1210-1217. PMID: 32127466, DOI: 10.1158/1535-7163.mct-19-0529.
- Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clinical Cancer Research 2020, 26: 1247-1257. PMID: 31527168, PMCID: PMC7528620, DOI: 10.1158/1078-0432.ccr-18-4071.
- Varga A, Soria JC, Hollebecque A, LoRusso P, Bendell J, Huang SA, Wagle MC, Okrah K, Liu L, Murray E, Sanabria-Bohorquez SM, Tagen M, Dokainish H, Mueller L, Burris H. A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors. Clinical Cancer Research 2020, 26: 1229-1236. PMID: 31848189, DOI: 10.1158/1078-0432.ccr-19-2574.
- Yap T, Gainor J, Burris H, Kummar S, Pachynski R, Callahan M, LoRusso P, Tykodi S, Gibney G, Falchook G, Rahma O, Seiwert T, Papadopoulos K, Mier J, Hashambhoy-Ramsay Y, Felitsky D, Lee D, McGrath L, Harvey C, Hooper E. Association of an RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial. Journal Of Clinical Oncology 2020, 38: 14-14. DOI: 10.1200/jco.2020.38.5_suppl.14.
- Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clinical Cancer Research 2019, 25: 6309-6319. PMID: 31420359, DOI: 10.1158/1078-0432.ccr-19-0578.
- Hamilton E, Vidula N, Ma C, LoRusso P, Bagley R, Yu Z, Annett M, Weitzman A, Conlan M, Weise A. 343P Phase I dose escalation study of a selective androgen receptor modulator RAD140 in estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer (BC). Annals Of Oncology 2019, 30: v123. DOI: 10.1093/annonc/mdz242.038.
- Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Bullington J, Sardone M, Chen J, Brooks C, Shemesh S, Bauer T. 466P Interim results from trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumours. Annals Of Oncology 2019, 30: v175. DOI: 10.1093/annonc/mdz244.028.
- Calvo E, de Jonge M, Rasco D, Moreno V, Chang Y, Chiney M, Motwani M, Penugonda S, Petrich A, Ratain M, LoRusso P. 457P First-in-human study of ABBV-621 in patients (pts) with previously treated sold tumours: Dose-optimization cohorts. Annals Of Oncology 2019, 30: v169-v170. DOI: 10.1093/annonc/mdz244.019.
- Wainberg Z, Sachdev J, Bauer T, Pant S, Chawla S, Marina N, Xiang H, Deng W, Schmidt M, Patnaik A, LoRusso P. 1198P FPA150 (B7-H4 antibody) phase I update in advanced solid tumours: Monotherapy and in combination with pembrolizumab. Annals Of Oncology 2019, 30: v489. DOI: 10.1093/annonc/mdz253.024.
- Jung KH, LoRusso P, Burris H, Gordon M, Bang YJ, Hellmann MD, Cervantes A, de Olza M, Marabelle A, Hodi FS, Ahn MJ, Emens LA, Barlesi F, Hamid O, Calvo E, McDermott D, Soliman H, Rhee I, Lin R, Pourmohamad T, Suchomel J, Tsuhako A, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis SL. Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 3220-3228. PMID: 30770348, PMCID: PMC7980952, DOI: 10.1158/1078-0432.ccr-18-2740.
- Naing A, Thistlethwaite F, Spira A, Garcia-Corbacho J, Randhawa M, Eskens F, O'Neil B, Lavernia J, Uboha N, Hamid O, El-Khoueiry A, Benson B, Garner W, Huels V, Arkenau H, LoRusso P. CX-072, a PD-L1 Probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072. Journal Of Clinical Oncology 2019, 37: 2513-2513. DOI: 10.1200/jco.2019.37.15_suppl.2513.
- Chow L, Gainor J, Lakhani N, Chung H, Lee K, Lee J, LoRusso P, Bang Y, Hodi F, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase I study of ALX148, a CD47 blocker, in combination with established anticancer antibodies in patients with advanced malignancy. Journal Of Clinical Oncology 2019, 37: 2514-2514. DOI: 10.1200/jco.2019.37.15_suppl.2514.
- Sachdev J, Bauer T, Chawla S, Pant S, Patnaik A, Wainberg Z, Inamdar S, Marina N, Sun S, Schmidt M, Xiang H, LoRusso P. Phase 1a/1b study of first-in-class B7-H4 antibody, FPA150, as monotherapy in patients with advanced solid tumors. Journal Of Clinical Oncology 2019, 37: 2529-2529. DOI: 10.1200/jco.2019.37.15_suppl.2529.
- Ratain M, Doi T, De Jonge M, LoRusso P, Dunbar M, Chiney M, Motwani M, Glasgow J, Petrich A, Rasco D, Calvo E. Phase 1, first-in-human study of TRAIL receptor agonist fusion protein ABBV-621. Journal Of Clinical Oncology 2019, 37: 3013-3013. DOI: 10.1200/jco.2019.37.15_suppl.3013.
- Mobasher M, Miller R, Kwei L, Strahs D, Das V, Luciano G, Powderly J, Merchan J, Barve M, LoRusso P, Tripathi A, Luke J. A phase I/Ib multicenter study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers. Journal Of Clinical Oncology 2019, 37: tps2646-tps2646. DOI: 10.1200/jco.2019.37.15_suppl.tps2646.
- Yap T, Papadopoulos K, LoRusso P, Wong D, Hu-Lieskovan S, Holz J. A first-in-human phase I study of FS118, an anti-LAG-3/PD-L1 bispecific antibody in patients with solid tumors that have progressed on prior PD-1/PD-L1 therapy. Journal Of Clinical Oncology 2019, 37: tps2652-tps2652. DOI: 10.1200/jco.2019.37.15_suppl.tps2652.
- Chong C, Bauer T, Laurie S, Patel M, Yamamoto N, Davenport T, Geng J, Gibson N, Vallaster M, LoRusso P. A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2019, 37: tps3166-tps3166. DOI: 10.1200/jco.2019.37.15_suppl.tps3166.
- Hong DS, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci DVT, Chan E, Bekaii-Saab T, Gadgeel S, Loberg RD, Amore BM, Hwang YC, Tang R, Ngarmchamnanrith G, Kwak EL. Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 2403-2413. PMID: 30425090, PMCID: PMC6892342, DOI: 10.1158/1078-0432.ccr-18-1341.
- Lorusso P, Chawla S, Bendell J, Shields A, Shapiro G, Rajagopalan P, Cyris C, Bruns I, Mei J, Souza F, Rasco D, Eder J, Tolcher A. 422P First-in-human study of the monopolar spindle 1 (Mps1) kinase inhibitor BAY 1161909 in combination with paclitaxel in subjects with advanced malignancies. Annals Of Oncology 2018, 29: viii138. DOI: 10.1093/annonc/mdy279.410.
- Bauer T, Barve M, Chiorean E, Lorusso P, Courtney K, Qi D, Olguin A, Bullington J, Sardone M, Dunn V, Shemesh S, Chen J, Brooks C, Wang J. 428P Interim results from a phase I trial of SL-801: A novel XPO-1 inhibitor, in patients with advanced solid tumors. Annals Of Oncology 2018, 29: viii140. DOI: 10.1093/annonc/mdy279.415.
- Plummer R, Sanborn R, de Vries E, Lorusso P, Arkenau H, Uboha N, Wydmanski J, Fidler M, Boni V, Garcia-Corbacho J, Humphrey R, Will M, Autio K, El-Khoueiry A, van Oordt C, Thistlethwaite F. 436P Preliminary results of the first-in-human, dose-finding PROCLAIM-CX-072 trial evaluating the PD-L1 probody therapeutic CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors. Annals Of Oncology 2018, 29: viii143. DOI: 10.1093/annonc/mdy279.423.
- Ferrarotto R, Eckhardt G, Patnaik A, LoRusso P, Faoro L, Heymach J, Kapoun A, Xu L, Munster P. A phase I dose-escalation and dose-expansion study of brontictuzumab in subjects with selected solid tumors. Annals Of Oncology 2018, 29: 1561-1568. PMID: 29726923, DOI: 10.1093/annonc/mdy171.
- Atrafi F, Boix O, Rajagopalan P, Tolcher A, LoRusso P, Eder J, Sankhala K, Chawla S, Subbiah V, Diamond J, Gutierrez M, Mathijssen R, Mei J, Verweij J, Bruns I, Lolkema M. A randomized Bayesian phase 1 design combining an MPS-1 inhibitor with paclitaxel: A strategy to improve determination of the incremental toxicity of a novel compound over a known backbone therapy. Journal Of Clinical Oncology 2018, 36: 2537-2537. DOI: 10.1200/jco.2018.36.15_suppl.2537.
- Wang J, Barve M, Chiorean E, LoRusso P, Courtney K, Qi D, Olguin A, Bullington J, Sardone M, Dunn V, Shemesh S, Chen J, Brooks C, Bauer T. Interim results from a phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2018, 36: 2560-2560. DOI: 10.1200/jco.2018.36.15_suppl.2560.
- O'Neil B, Modi D, LoRusso P, Wong S, Motwani M, Sachdev J, Wolff J, Patel S, Hu B, Szmulewitz R, Sood A, Barve M, McKee M, Piha-Paul S. Gene expression and cytokine modulation in a first in human (FIH) study of a pan BET inhibitor ABBV-075 in solid tumors. Journal Of Clinical Oncology 2018, 36: 2570-2570. DOI: 10.1200/jco.2018.36.15_suppl.2570.
- Yap T, Burris H, Kummar S, Falchook G, Pachynski R, LoRusso P, Tykodi S, Gibney G, Gainor J, Rahma O, Seiwert T, Meric-Bernstam F, Blum Murphy M, Litton J, Hooper E, Hirsch H, Harvey C, Clancy M, McClure T, Callahan M. ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers. Journal Of Clinical Oncology 2018, 36: 3000-3000. DOI: 10.1200/jco.2018.36.15_suppl.3000.
- Lakhani N, LoRusso P, Hafez N, Krishnamurthy A, O'Rourke T, Kamdar M, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma. Journal Of Clinical Oncology 2018, 36: 3068-3068. DOI: 10.1200/jco.2018.36.15_suppl.3068.
- Sanborn R, Menke C, Autio K, Arkenau H, Corbacho J, LoRusso P, Plummer E, Uboha N, Freeman M, Wydmanski J, Huels V, Zheng B, Will M, Humphrey R, Thistlethwaite F, de Vries E, El-Khoueiry A. Preliminary interim results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 Probody therapeutic (Pb-Tx) CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2018, 36: 3072-3072. DOI: 10.1200/jco.2018.36.15_suppl.3072.
- Overman M, LoRusso P, Strickler J, Patel S, Clarke S, Noonan A, Prasanna T, Amin M, Nemunaitis J, Desai J, O'Byrne K, George T, Englert J, She D, Cooper Z, Wu Y, Khan A, Kumar R, Bendell J. Safety, efficacy and pharmacodynamics (PD) of MEDI9447 (oleclumab) alone or in combination with durvalumab in advanced colorectal cancer (CRC) or pancreatic cancer (panc). Journal Of Clinical Oncology 2018, 36: 4123-4123. DOI: 10.1200/jco.2018.36.15_suppl.4123.
- Bauer T, Gounder M, Weise A, Schwartz G, Carvajal R, Kumar P, Zernovak O, Beck A, Doyle J, Mendell-Harary J, Kochan J, Chen S, LoRusso P, Tap W, Somaiah N, Hyman D, Meric-Bernstam F, Hong D. A phase 1 study of MDM2 inhibitor DS-3032b in patients with well/de-differentiated liposarcoma (WD/DD LPS), solid tumors (ST) and lymphomas (L). Journal Of Clinical Oncology 2018, 36: 11514-11514. DOI: 10.1200/jco.2018.36.15_suppl.11514.
- Piha-Paul S, Sachdev J, Barve M, LoRusso P, Szmulewitz R, Patel S, McKee M, Wolff J, Hu B, Sood A, Chen X, Wilson S, O'Neil B. Results of the first-in-human study of ABBV-075 (mivebresib), a pan-inhibitor of bromodomain (BD) and extra terminal (BET) proteins, in patients (pts) with relapsed/refractory (R/R) solid tumors. Journal Of Clinical Oncology 2018, 36: 2510-2510. DOI: 10.1200/jco.2018.36.15_suppl.2510.
- El-Khoueiry A, Desai J, Iyer S, Gadgeel S, Ramalingam S, Horn L, LoRusso P, Bajaj G, Kollia G, Qi Z, Basak S, Fischer B, Davis M, Bedard P. A phase I study of AL101, a pan-NOTCH inhibitor, in patients (pts) with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2018, 36: 2515-2515. DOI: 10.1200/jco.2018.36.15_suppl.2515.
- Lorusso P. 32IN Can adding PI3K inhibitors to the treatment cocktail alter outcome? Annals Of Oncology 2018, 29: iii5. DOI: 10.1093/annonc/mdy046.016.
- Yee D, Prat A, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Hua H, LoRusso P. 90TiP A phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumors, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/- endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: x25. DOI: 10.1093/annonc/mdx656.001.
- Prat A, Yee D, Sablin M, Iwata H, Johnston E, Bogenrieder T, Serra J, Stucke-Straub K, Russo P. 235TiP A Phase Ib trial of xentuzumab and abemaciclib in patients with locally advanced or metastatic solid tumours, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer (BC; +/-endocrine therapy), or non-small-cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: v72-v73. DOI: 10.1093/annonc/mdx364.017.
- Italiano A, Infante J, Shapiro G, Moore K, Lorusso P, Postel-Vinay S, Cousin S, Toulmonde M, Lucchesi C, Blackwood E, Mahrus S, Lu X, Tagen M, Schutzman J, Lauchle J, Soria J. 375PD Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine (gem) in patients (pts) with refractory solid tumors. Annals Of Oncology 2017, 28: v125. DOI: 10.1093/annonc/mdx367.009.
- Wang J, Nemunaitis J, Chiorean G, Lorusso P, Courtney K, Olguin A, Bullington J, Shemesh S, Chen J, Brooks C, Bauer T. 406P Ongoing phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors; Interim results. Annals Of Oncology 2017, 28: v135. DOI: 10.1093/annonc/mdx367.039.
- Schwartzberg LS, Yardley D, Elias A, Patel M, LoRusso P, Burris HA, Gucalp A, Peterson A, Blaney M, Steinberg J, Gibbons J, Traina TA. A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer. Clinical Cancer Research 2017, 23: 4046-4054. PMID: 28280092, DOI: 10.1158/1078-0432.ccr-16-2339.
- Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso P, Patel MR, Domchek SM, Balmaña J, Drew Y, Chen LM, Safra T, Montes A, Giordano H, Maloney L, Goble S, Isaacson J, Xiao J, Borrow J, Rolfe L, Shapira-Frommer R. A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors. Clinical Cancer Research 2017, 23: 4095-4106. PMID: 28264872, DOI: 10.1158/1078-0432.ccr-16-2796.
- Goff L, Azad N, Stein S, Whisenant J, Vaishampayan U, Hochster H, Connolly R, Weise A, LoRusso P, El-Rifai W, Berlin J. Phase I study combining the aurora kinase A (AURKA) inhibitor alisertib (Ali) with mFOLFOX in gastrointestinal (GI) cancer. Journal Of Clinical Oncology 2017, 35: 2593-2593. DOI: 10.1200/jco.2017.35.15_suppl.2593.
- Burris H, Gordon M, Hellmann M, LoRusso P, Emens L, Hodi F, Lieu C, Infante J, Tsai F, Eder J, Cleary J, Jelovac D, Tsuhako A, Mueller L, Lin R, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis S. A phase Ib dose escalation study of combined inhibition of IDO1 (GDC-0919) and PD-L1 (atezolizumab) in patients (pts) with locally advanced or metastatic solid tumors. Journal Of Clinical Oncology 2017, 35: 105-105. DOI: 10.1200/jco.2017.35.15_suppl.105.
- Tran B, Carvajal R, Marabelle A, Patel S, LoRusso P, Rasmussen E, Juan G, Upreti V, Ngarmchamnanrith G, Schöffski P. Dose escalation results from a first-in-human, phase 1 study of the glucocorticoid-induced TNF receptor-related protein (GITR) agonist AMG 228 in patients (Pts) with advanced solid tumors. Journal Of Clinical Oncology 2017, 35: 2521-2521. DOI: 10.1200/jco.2017.35.15_suppl.2521.
- Yokota T, Bendell J, LoRusso P, Tsushima T, Desai V, Kenmotsu H, Watanabe J, Ono A, Murugesan B, Silva J, Naito T, Greenberg J, Kumar P, Wang Y, Jikoh T, Shiga R, Ho A, Gounder M. A call for global harmonization of phase I oncology trials: Results from two parallel, first-in-human phase I studies of DS-7423, an oral PI3K/mTOR dual inhibitor in advanced solid tumors conducted in the United States and Japan. Journal Of Clinical Oncology 2017, 35: 2536-2536. DOI: 10.1200/jco.2017.35.15_suppl.2536.
- Mita M, LoRusso P, McArthur G, Kim E, Bray G, Hock N, Laille E, Aronchik I, Filvaroff E, Wu X, Bendell J. A phase Ia study of CC-90003, a selective extracellular signal-regulated kinase (ERK) inhibitor, in patients with relapsed or refractory BRAF or RAS-mutant tumors. Journal Of Clinical Oncology 2017, 35: 2577-2577. DOI: 10.1200/jco.2017.35.15_suppl.2577.
- Burris H, Callahan M, Tolcher A, Kummar S, Falchook G, Pachynski R, Tykodi S, Gibney G, Seiwert T, Gainor J, LoRusso P, Hilbert J, Apgar J, Hua F, Burke J, Lazaro M, Clancy M, Ding B, Trehu E, Yap T. Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC. Journal Of Clinical Oncology 2017, 35: 3033-3033. DOI: 10.1200/jco.2017.35.15_suppl.3033.
- Chaudhary A, Chao G, Braiteh F, Gordon M, Lee J, Lorusso P, Obasaju C, Wallin J. P2.03a-065 Lack of Drug-Drug Interaction (DDI) between Necitumumab and Gemcitabine or Cisplatin: A Phase 2, Open-Label, Nonrandomized Study Topic: Clinical Trials. Journal Of Thoracic Oncology 2017, 12: s928-s929. DOI: 10.1016/j.jtho.2016.11.1275.
- Li C, Agarwal P, Gibiansky E, Jin J, Dent S, Gonçalves A, Nijem I, Strasak A, Harle-Yge M, Chernyukhin N, LoRusso P, Girish S. A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function. Clinical Pharmacokinetics 2016, 56: 1069-1080. PMID: 27995530, DOI: 10.1007/s40262-016-0496-y.
- LoRusso P, Miller K, Shields A, Saito K, Yoshida K, Aoyama T, Winkler R, Benedetti F, Lenz H. 361 Phase 1 Study of first-in-class dUTPase inhibitor, TAS-114 in combination with capecitabine in patients with advanced solid tumors. European Journal Of Cancer 2016, 69: s119. DOI: 10.1016/s0959-8049(16)32953-7.
- Varga A, Soria J, Hollebecque A, LoRusso P, Vaishampayan U, Okrah K, Huang S, Murray E, Sanabria-Bohorquez S, Tagen M, Dokainish H, Mueller L, Burris H. 18 A first-in-human phase I study to evaluate the ERK1/2 inhibitor GDC-0994 in patients with advanced solid tumors. European Journal Of Cancer 2016, 69: s11. DOI: 10.1016/s0959-8049(16)32624-7.
- Nogova L, Sequist LV, Garcia J, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. Journal Of Clinical Oncology 2016, 35: 157-165. PMID: 27870574, PMCID: PMC6865065, DOI: 10.1200/jco.2016.67.2048.
- McLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development. 2016, 321-344. DOI: 10.1002/9781119060727.ch13.
- Sanai N, Li J, Boerner J, Dhruv H, Berens M, LoRusso P. ACTR-10. PHASE 0 TRIAL OF AZD1775 IN FIRST-RECURRENCE GLIOBLASTOMA PATIENTS. Neuro-Oncology 2016, 18: vi3-vi3. DOI: 10.1093/neuonc/now212.009.
- Modi S, Eder J, Lorusso P, Weekes C, Chandarlapaty S, Tolaney S, McLaughlin J, Camidge D, Chang C, Nazzal D, Chen S, Schuth E, Brunstein F, Darbonne W, Flanagan W, Ungewickell A, Shapiro G. 357O A phase I study evaluating DLYE5953A, an antibody-drug conjugate targeting the tumor-associated antigen lymphocyte antigen 6 complex locus E (Ly6E), in patients (Pts) with solid tumors. Annals Of Oncology 2016, 27: vi114. DOI: 10.1093/annonc/mdw368.01.
- Geretti E, Espelin C, Adiwijaya B, Dumont N, Coma S, Koncki Z, Garcia G, Bloom T, Rimkunas V, Reynolds J, Campbell K, Moyo V, Molnar I, Lorusso P, Miller K, Ma C, Krop I, Munster P, Wickham T. 1560P Quantitative evaluation of HER2-mediated cellular uptake of the HER2-targeted antibody-liposomal doxorubicin conjugate MM-302 suggests potential for treating HER2-intermediate tumors. Annals Of Oncology 2016, 27: vi539. DOI: 10.1093/annonc/mdw392.41.
- Falchook G, Bauer T, LoRusso P, McLaughlin J, LaVallee T, Peck R, Eder J. Safety, pharmacokinetics (PK), pharmacodynamics (Pd), and antitumor activity in a phase 1b study evaluating anti-ErbB3 antibody KTN3379 in adults with advanced tumors alone and with targeted therapies. Journal Of Clinical Oncology 2016, 34: 2501-2501. DOI: 10.1200/jco.2016.34.15_suppl.2501.
- Calvo E, Azaro A, Dirix L, Huizing M, Senecal F, LoRusso P, Yee L, Keung C, Triantos S, Park Y, Knoblauch R, Parekh T, Demetri G, vonMehren M. Trabectedin (T)-related liver toxicity: Results of a pharmacokinetic study with T in patients with hepatic dysfunction (OVC1004) and experience from a phase 3 clinical trial (SAR3007). Journal Of Clinical Oncology 2016, 34: 11064-11064. DOI: 10.1200/jco.2016.34.15_suppl.11064.
- Sanai N, Li J, Boerner J, Dhruv H, Berens M, LoRusso P. Phase 0 trial of AZD1775 in patients with first-recurrence glioblastoma. Journal Of Clinical Oncology 2016, 34: 2008-2008. DOI: 10.1200/jco.2016.34.15_suppl.2008.
- Gounder M, Bauer T, Schwartz G, Masters T, Carvajal R, Song S, Kumar P, Gajee R, Zernovak O, Rosen M, Kochan J, Chen S, Hyman D, Gokmen S, Meric-Bernstam F, LoRusso P, Somaiah N, Weise A, Hong D. A phase 1 study of the MDM2 inhibitor DS-3032b in patients (pts) with advanced solid tumors and lymphomas. Journal Of Clinical Oncology 2016, 34: 2581-2581. DOI: 10.1200/jco.2016.34.15_suppl.2581.
- Hamilton E, Patel M, Gluck W, Weise A, Pant S, Jones S, LoRusso P, Kittaneh M, Cosulich S, Harrington E, Littlewood G, Oelmann E, Burris H. A phase I study of continuous (Con) and intermittent (Int) AZD2014 plus fulvestrant (F) in patients (pts) with estrogen receptor (ER+) metastatic breast cancer (BC). Journal Of Clinical Oncology 2016, 34: 563-563. DOI: 10.1200/jco.2016.34.15_suppl.563.
- Schwartz GK, Dickson MA, LoRusso P, Sausville EA, Maekawa Y, Watanabe Y, Kashima N, Nakashima D, Akinaga S. Preclinical and first‐in‐human phase I studies of KW‐2450, an oral tyrosine kinase inhibitor with insulin‐like growth factor receptor‐1/insulin receptor selectivity. Cancer Science 2016, 107: 499-506. PMID: 26850678, PMCID: PMC4832855, DOI: 10.1111/cas.12906.
- Sewald N, Ramchandren R, LoRusso P. Clinical development of antibody–drug conjugates. 2015, 136-148. DOI: 10.4155/fseb2013.14.341.
- Curigliano G, Aftimos P, Dees E, LoRusso P, Pegram M, Awada A, Huang B, Cesari R, Jiang Y, Shaik M, Kern K, Locatelli M. Phase I dose-finding study of the gamma secretase inhibitor PF-03084014 (PF-4014) in combination with docetaxel in patients (pts) with advanced triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2015, 33: 1068-1068. DOI: 10.1200/jco.2015.33.15_suppl.1068.
- Juric D, De Bono J, LoRusso P, Nemunaitis J, Heath E, Kwak E, Macarulla T, Geuna E, de Miguel Luken M, Patel C, Kuida K, Sankoh S, Zohren F, Shou Y, Tabernero J. First-in-human, phase I, dose-escalation study of selective PI3Kα isoform inhibitor MLN1117 in patients (pts) with advanced solid malignancies. Journal Of Clinical Oncology 2015, 33: 2501-2501. DOI: 10.1200/jco.2015.33.15_suppl.2501.
- Papadopoulos K, Tolcher A, Patnaik A, Rasco D, Chambers G, Beeram M, Savage R, Hall T, Schwartz B, Kazakin J, LoRusso P. Phase 1, first-in-human study of ARQ 087, an oral pan-Fibroblast Growth Factor Receptor (FGFR) inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2015, 33: 2545-2545. DOI: 10.1200/jco.2015.33.15_suppl.2545.
- Bauer T, Infante J, Eder J, LoRusso P, LaVallee T, Gedrich R, Sidor C, Falchook G. A phase 1, open-label study to evaluate the safety and pharmacokinetics of the anti ErbB3 antibody, KTN3379, alone or in combination with targeted therapies in patients with advanced tumors. Journal Of Clinical Oncology 2015, 33: 2598-2598. DOI: 10.1200/jco.2015.33.15_suppl.2598.
- Goncalves P, Soubani A, Heilbrun L, Smith D, Villegas J, LoRusso P. Pulmonary function tests (PFT) results in a phase 1 (Ph1) oncology patient (pt) population. Journal Of Clinical Oncology 2015, 33: e17759-e17759. DOI: 10.1200/jco.2015.33.15_suppl.e17759.
- Shapiro G, LoRusso P, Vaishampayan U, Kittaneh M, Hilton J, Cleary J, Velastegui K, Xuan D, Hua S, Shazer R, Borghaei H. First-in-human, dose-escalation, safety, and PK study of a novel 5T4-ADC in patients with advanced solid tumors. Journal Of Clinical Oncology 2015, 33: tps2603-tps2603. DOI: 10.1200/jco.2015.33.15_suppl.tps2603.
- Kwak E, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci D, Chan E, Bekaii-Saab T, Amore B, Hwang Y, Tang R, Ngarmchamnanrith G, Hong D. Clinical activity of AMG 337, an oral MET kinase inhibitor, in adult patients (pts) with MET-amplified gastroesophageal junction (GEJ), gastric (G), or esophageal (E) cancer. Journal Of Clinical Oncology 2015, 33: 1-1. DOI: 10.1200/jco.2015.33.3_suppl.1.
- Kang Y, LoRusso P, Salgia R, Yen C, Lin C, Ramanathan R, Kaminker P, Sokolova I, Bhathena A, Wang L, Naumovski L, Strickler J. Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC). Journal Of Clinical Oncology 2015, 33: 167-167. DOI: 10.1200/jco.2015.33.3_suppl.167.
- Wang D, Braiteh F, Lee J, Denlinger C, Shepard D, Chaudhary A, Lin Y, Gao L, Asakiewicz C, Nasroulah F, LoRusso P. Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. Journal Of Clinical Oncology 2015, 33: 691-691. DOI: 10.1200/jco.2015.33.3_suppl.691.
- Morgensztern D, LoRusso P, Boerner S, Herbst R, Eder J. 48 Phase I Trials Today. 2015, 661-676.e2. DOI: 10.1016/b978-1-4557-4066-6.00048-2.
- Altman R, Dunker A, Hunter L, Ritchie M, Murray T, Klein T, NASSER S, KURDOGLU A, IZATT T, ALDRICH J, RUSSELL M, CHRISTOFORIDES A, TEMBE W, KIEFER J, CORNEVEAUX J, BYRON S, FORMAN K, ZUCCARO C, KEATS J, LORUSSO P, CARPTEN J, TRENT J, CRAIG D. AN INTEGRATED FRAMEWORK FOR REPORTING CLINICALLY RELEVANT BIOMARKERS FROM PAIRED TUMOR/NORMAL GENOMIC AND TRANSCRIPTOMIC SEQUENCING DATA IN SUPPORT OF CLINICAL TRIALS IN PERSONALIZED MEDICINE. Biocomputing 2014, 56-67. PMID: 25592568, DOI: 10.1142/9789814644730_0007.
- Patnaik A, LoRusso P, Munster P, Tolcher A, Davis S, Heymach J, Ferraroto R, Xu L, Kapoun A, Faoro L, Lewicki J, Dupont J, Eckhardt S. 2 Safety and early evidence of activity of a first-in-human phase I study of the novel cancer stem cell (CSC) targeting antibody OMP-52M51 (anti-Notch1) administered intravenously to patients with certain advanced solid tumors. European Journal Of Cancer 2014, 50: 7. DOI: 10.1016/s0959-8049(14)70128-5.
- LoRusso P, LaVallee T, Kimmel L, Lubeski C, Gedrich R, Sidor C. 210 A phase 1 study of KTN3379, a human anti-ErbB3 monoclonal antibody in patients with advanced cancers. European Journal Of Cancer 2014, 50: 71. DOI: 10.1016/s0959-8049(14)70336-3.
- Papadopoulos K, Tolcher A, Kittaneh M, Patniak A, Rasco D, Chambers G, Newth G, Savage R, Hall T, Schwartz B, Kazakin J, LoRusso P. 389 A phase 1, dose-escalation, first-in-human study of ARQ 087, an oral pan-FGFR inhibitor, in adult subjects with advanced solid tumors. European Journal Of Cancer 2014, 50: 125. DOI: 10.1016/s0959-8049(14)70515-5.
- Kristeleit R, Shapira-Frommer R, Burris H, Patel M, Lorusso P, Oza A, Balmaña J, Domchek S, Chen L, Montes A, Plummer R, Arkenau H, Maloney L, Dominy E, Shapiro G. 882PD Phase 1/2 Study of Oral Rucaparib: Updated Phase 1 and Preliminary Phase 2 Results. Annals Of Oncology 2014, 25: iv307. DOI: 10.1093/annonc/mdu338.8.
- Strickler J, LoRusso P, Yen C, Lin C, Kang Y, Kaminker P, Ansell P, Bhathena A, Wong S, Dudley M, Naumovski L, Ramanathan R. Phase 1, open-label, dose-escalation, and expansion study of ABT-700, an anti-C-met antibody, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 2507-2507. DOI: 10.1200/jco.2014.32.15_suppl.2507.
- Hong D, LoRusso P, Hamid O, Beaupre D, Janku F, Khan R, Kittaneh M, Loberg R, Amore B, Caudillo I, Hwang Y, Tang R, Ngarmchamnanrith G, Kwak E. First-in-human study of AMG 337, a highly selective oral inhibitor of MET, in adult patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 2508-2508. DOI: 10.1200/jco.2014.32.15_suppl.2508.
- Tawbi H, Chu E, Lin Y, Hyman D, Goel S, Rudek M, Dowlati A, LoRusso P, Mulkerin D, Chew H, Kiesel B, Pollice L, Appleman L, Puhalla S, Stoller R, Lee J, Ivy P, Beumer J. Early phase I study of the PARP inhibitor veliparib (ABT-888) alone or in combination with carboplatin/paclitaxel (CP) in patients with varying degrees of hepatic or renal dysfunction: A study of the NCI-Organ Dysfunction Working Group (ODG). Journal Of Clinical Oncology 2014, 32: 2572-2572. DOI: 10.1200/jco.2014.32.15_suppl.2572.
- Kristeleit R, Burris H, LoRusso P, Patel M, Asghar U, El-Khouly F, Calvert A, Infante J, Hilton J, Tolaney S, Kittaneh M, Giordano H, Borrow J, Jaw-Tsai S, Shapiro G. Phase 1/2 study of oral rucaparib: Final phase 1 results. Journal Of Clinical Oncology 2014, 32: 2573-2573. DOI: 10.1200/jco.2014.32.15_suppl.2573.
- Maitland M, Ou S, Tolcher A, LoRusso P, Bahceci E, Ball H, Park J, Yuen G, Pesco Koplowitz L, Li T. Safety, activity, and pharmacokinetics of an oral anaplastic lymphoma kinase (ALK) inhibitor, ASP3026, observed in a “fast follower” phase 1 trial design. Journal Of Clinical Oncology 2014, 32: 2624-2624. DOI: 10.1200/jco.2014.32.15_suppl.2624.
- Isakoff S, Saleh M, Lugovskoy A, Manoli S, Czibere A, LoRusso P, Arnedos M. First-in-human study of MM-141: A novel tetravalent monoclonal antibody targeting IGF-1R and ErbB3. Journal Of Clinical Oncology 2014, 32: 3068-3068. DOI: 10.1200/jco.2014.32.15_suppl.3068.
- Schwartzberg L, Yardley D, Elias A, Patel M, Gucalp A, Burris H, Peterson A, Hannah A, Blaney M, Gibbons J, Tudor I, Steinberg J, LoRusso P, Infante J, Hudis C, Traina T. Enzalutamide plus exemestane: A pilot study to assess safety, pharmacokinetics, and effects on circulating estrogens in women with advanced hormone-positive breast cancer. Journal Of Clinical Oncology 2014, 32: 545-545. DOI: 10.1200/jco.2014.32.15_suppl.545.
- Moore K, Ponte J, LoRusso P, Birrer M, Bauer T, Borghaei H, O'Malley D, Ruiz-Soto R, Lutz R, Malik L. Relationship of pharmacokinetics (PK), toxicity, and initial evidence of clinical activity with IMGN853, a folate receptor alpha (FRa) targeting antibody drug conjugate in patients (Pts) with epithelial ovarian cancer (EOC) and other FRa-positive solid tumors. Journal Of Clinical Oncology 2014, 32: 5571-5571. DOI: 10.1200/jco.2014.32.15_suppl.5571.
- Lewis K, Sekulic A, Hauschild A, Migden M, Oro A, LoRusso P, Rudin C, Dirix L, Solomon J, Hainsworth J, Williams S, Hou J, Von Hoff D. Vismodegib in the treatment of patients with metastatic basal cell carcinoma (mBCC) and distant metastases: Survival in the pivotal phase II and phase I studies. Journal Of Clinical Oncology 2014, 32: 9012-9012. DOI: 10.1200/jco.2014.32.15_suppl.9012.
- Traina T, Yardley D, Patel M, Schwartzberg L, Elias A, Gucalp A, Blaney M, Gibbons J, Hudis C, LoRusso P. 10P A Phase 1 Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide Alone or Combined with an Aromatase Inhibitor in Women with Advanced Breast Cancer. Annals Of Oncology 2014, 25: i4. DOI: 10.1093/annonc/mdu064.1.
- Hendriks B, Shields A, Siegel B, Miller K, Munster P, Ma C, Campbell K, Moyo V, Wickham T, LoRusso P. 55P PET/CT Imaging of 64CU-Labelled HER2 Liposomal Doxorubicin (64CU-MM-302) Quantifies Variability of Liposomal Drug Delivery to Diverse Tumor Lesions in HER2-Positive Breast Cancer Patients. Annals Of Oncology 2014, 25: i19. DOI: 10.1093/annonc/mdu068.1.
- Britten C, Adjei A, Millham R, Houk B, Borzillo G, Pierce K, Wainberg Z, LoRusso P. Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer. Investigational New Drugs 2014, 32: 575-575. DOI: 10.1007/s10637-014-0069-6.
- LoRusso P, Hecht J, Thai D, Hawkins M, Dong H, Tolcher A. Phase I and IIa studies of simtuzumab alone and in combination with FOLFIRI in patients with advanced solid tumors. Journal Of Clinical Oncology 2014, 32: 554-554. DOI: 10.1200/jco.2014.32.3_suppl.554.
- Yardley D, Krop I, LoRusso P, Robert N, Mayer M, Abidoye O, Lai C, Yoo B, Perez E. Trastuzumab emtansine (T-DM1) in previously treated HER2-positive metastatic breast cancer (MBC): Results from an expanded access study. Journal Of Clinical Oncology 2013, 31: 166-166. DOI: 10.1200/jco.2013.31.26_suppl.166.
- Jimeno A, LoRusso P, Strother R, Diamond J, Plato L, Younger A, Messersmith W, Kittaneh M, Sawyer D, Adriaens L, Liu L, Kao R, DiCioccio A, Brownstein C, Lowy I, Trail P, Chiorean E. Phase I study of REGN421 (R)/SAR153192, a fully-human delta-like ligand 4 (Dll4) monoclonal antibody (mAb), in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2502-2502. DOI: 10.1200/jco.2013.31.15_suppl.2502.
- Amaravadi R, Senzer N, Martin L, Schilder R, LoRusso P, Papadopoulos K, Weng D, Graham M, Adjei A. A phase I study of birinapant (TL32711) combined with multiple chemotherapies evaluating tolerability and clinical activity for solid tumor patients. Journal Of Clinical Oncology 2013, 31: 2504-2504. DOI: 10.1200/jco.2013.31.15_suppl.2504.
- Fontes Jardim D, Hess K, LoRusso P, Kurzrock R, Hong D. Predictive value of phase I trials for safety and final approved dose in later trials: Analysis of 33,845 patients. Journal Of Clinical Oncology 2013, 31: 2509-2509. DOI: 10.1200/jco.2013.31.15_suppl.2509.
- Moore K, Bendell J, Olszanski A, Desai M, Jansen M, Scheyer R, Senaldi G, LoRusso P. Phase I, first-in-human, open-label, dose-escalation study of U3-1565, a fully human anti-HB-EGF monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2519-2519. DOI: 10.1200/jco.2013.31.15_suppl.2519.
- Adjei A, LoRusso P, Ribas A, Sosman J, Pavlick A, Dy G, Zhou X, Gangolli E, Walker R, Kneissl M, Faucette S, Neuwirth R, Bozon V. Phase I, dose-escalation study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2528-2528. DOI: 10.1200/jco.2013.31.15_suppl.2528.
- Kurkjian C, LoRusso P, Sankhala K, Birrer M, Kirby M, Ladd S, Hawes S, Running K, O'Leary J, Moore K. A phase I, first-in-human study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of IMGN853 in patients (Pts) with epithelial ovarian cancer (EOC) and other FOLR1-positive solid tumors. Journal Of Clinical Oncology 2013, 31: 2573-2573. DOI: 10.1200/jco.2013.31.15_suppl.2573.
- Kristeleit R, Shapiro G, LoRusso P, Infante J, Flynn M, Patel M, Tolaney S, Hilton J, Calvert A, Giordano H, Isaacson J, Borrow J, Allen A, Jaw-Tsai S, Burris H. A phase I dose-escalation and PK study of continuous oral rucaparib in patients with advanced solid tumors. Journal Of Clinical Oncology 2013, 31: 2585-2585. DOI: 10.1200/jco.2013.31.15_suppl.2585.
- Patnaik A, LoRusso P, Ball H, Bahceci E, Yuen G, Papadopoulos K, Kittaneh M, Tolcher A. Pharmacokinetics and safety of an oral ALK inhibitor, ASP3026, observed in a phase I dose escalation trial. Journal Of Clinical Oncology 2013, 31: 2602-2602. DOI: 10.1200/jco.2013.31.15_suppl.2602.
- Senzer N, LoRusso P, Martin L, Schilder R, Amaravadi R, Papadopoulos K, Segota Z, Weng D, Graham M, Adjei A. Phase II clinical activity and tolerability of the SMAC-mimetic birinapant (TL32711) plus irinotecan in irinotecan-relapsed/refractory metastatic colorectal cancer. Journal Of Clinical Oncology 2013, 31: 3621-3621. DOI: 10.1200/jco.2013.31.15_suppl.3621.
- Goncalves P, Kummar S, Siu L, Hansen A, Savvides P, Sukari A, Chao J, Heilbrun L, Pilat M, Smith D, Casetta L, Boerner S, LoRusso P. A phase II study of suberoylanilide hydroxamic acid (SAHA) in subjects with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC). Journal Of Clinical Oncology 2013, 31: 6045-6045. DOI: 10.1200/jco.2013.31.15_suppl.6045.
- Infante J, Powderly J, Burris H, Kittaneh M, Grice J, Smothers J, Brett S, Fleming M, May R, Marshall S, Devenport M, Pillemer S, Pardoll D, Chen L, Langermann S, LoRusso P. Clinical and pharmacodynamic (PD) results of a phase I trial with AMP-224 (B7-DC Fc) that binds to the PD-1 receptor. Journal Of Clinical Oncology 2013, 31: 3044-3044. DOI: 10.1200/jco.2013.31.15_suppl.3044.
- Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma. British Journal Of Cancer 2013, 108: 826-830. PMID: 23412108, PMCID: PMC3590681, DOI: 10.1038/bjc.2013.46.
- Haluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. 609 A Phase 1 Study of MEDI-573, an Investigational Monoclonal Antibody That Targets IGF-I and IGF-II: Safety, Pharmacokinetics, and Antitumor Activity in Adults with Advanced Solid Tumors. European Journal Of Cancer 2012, 48: 187-188. DOI: 10.1016/s0959-8049(12)72406-1.
- Messersmith W, LoRusso P, Cleary J, Dasari A, Huang B, Shaik N, Cesari R, McLachlan K, Kern K, Shapiro G. 588 A First-in-patient Phase I Study of the Novel Gamma Secretase Inhibitor PF-03084014 in Patients with Advanced Solid Tumor Malignancies. European Journal Of Cancer 2012, 48: 180. DOI: 10.1016/s0959-8049(12)72385-7.
- Macaulay V, Middleton M, Protheroe A, Tolcher A, Dieras V, Sessa C, Bahleda R, Blay J, LoRusso P, Mery-Mignard D, Soria J. Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors. Annals Of Oncology 2012, 24: 784-791. PMID: 23104723, PMCID: PMC3574548, DOI: 10.1093/annonc/mds511.
- Adjei A, LoRusso P, Ribas A, Sosman J, Dy G, Chmielowski B, Lipman P, Zhou X, Gangolli E, Bozón V. 456P Multicenter, Dose-Escalation Study of the Investigational Drug Tak-733, An Oral Mek inhibitor, in Patients (PTS) with Advanced Solid Tumors: Preliminary Phase 1 Results. Annals Of Oncology 2012, 23: ix158. DOI: 10.1016/s0923-7534(20)33014-3.
- Rixe O, Puzanov I, LoRusso P, Yin J, Doroumian S, Zhi X, Olszanski A. 497P Dose-Escalation Phase I Study of Cabazitaxel (CBZ) + Gemcitabine (GEM) in Patients (PTS) with Metastatic or Unresectable Advanced Solid Malignancy. Annals Of Oncology 2012, 23: ix170. DOI: 10.1016/s0923-7534(20)33059-3.
- Chiu Y, LoRusso P, Ricker J, Li X, Pradhan R, Carlson D. 507 Phase I, Open-Label, Randomized, Crossover Study Evaluating the Effects of Linifanib on Qtc Intervals in Patients with Solid Tumors. Annals Of Oncology 2012, 23: ix173. DOI: 10.1016/s0923-7534(20)33069-6.
- Weiss G, Oro A, Chang A, Solomon J, LoRusso P, Hamid O, Chen D, McKenna E, Feng S, Hainsworth J. 1111PD Expanded Access Study of Advanced Bcc Patients Treated with the Hedgehog-Pathway Inhibitor Vismodegib. Annals Of Oncology 2012, 23: ix362. DOI: 10.1016/s0923-7534(20)33683-8.
- Han H, Tan A, Weiss G, Sullivan D, Strosberg J, Collins S, Moss R, Wu J, Ewesuedo R, LoRusso P. A first-in-human, phase I safety and pharmacokinetic study of genz-644282, a non-camptothecin topoisomerase I inhibitor, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2534-2534. DOI: 10.1200/jco.2012.30.15_suppl.2534.
- LoRusso P, Shapiro G, Pandya S, Kwak E, Jones C, Belvin M, Musib L, de Crespigny A, McKenzie M, Gates M, Chan I, Bendell J. A first-in-human phase Ib study to evaluate the MEK inhibitor GDC-0973, combined with the pan-PI3K inhibitor GDC-0941, in patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: 2566-2566. DOI: 10.1200/jco.2012.30.15_suppl.2566.
- Borad M, Ramanathan R, Bessudo A, LoRusso P, Shepard H, Maneval D, Jiang P, Zhu J, Frost G, Infante J. Targeting hyaluronan (HA) in tumor stroma: A phase I study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of pegylated hyaluronidase (PEGPH20) in patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 2579-2579. DOI: 10.1200/jco.2012.30.15_suppl.2579.
- Fetterly G, Liu B, Senzer N, Amaravadi R, Schilder R, Martin L, LoRusso P, Papadopoulos K, Adjei A, Zagst P, McKinlay M, Weng D, Graham M. Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens. Journal Of Clinical Oncology 2012, 30: 3029-3029. DOI: 10.1200/jco.2012.30.15_suppl.3029.
- Calles A, Brana I, LoRusso P, Yee L, Puchalski T, Seetharam S, Balvers M, De Boer C, Elsayed Y, Calvo E, Tabernero J. Phase Ib study of CNTO 888 (anti-CCL 2) in combination with chemotherapies for treatment of patients with solid tumors. Journal Of Clinical Oncology 2012, 30: 3059-3059. DOI: 10.1200/jco.2012.30.15_suppl.3059.
- Alsina M, Tabernero J, Shapiro G, Burris H, Infante J, Weiss G, Cervantes-Ruiperez A, Gounder M, Paz-Ares L, Falzone R, Hill J, Cehelsky J, Vaishnaw A, Gollob J, LoRusso P. Open-label extension study of the RNAi therapeutic ALN-VSP02 in cancer patients responding to therapy. Journal Of Clinical Oncology 2012, 30: 3062-3062. DOI: 10.1200/jco.2012.30.15_suppl.3062.
- Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Activity of insulin growth factor-receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic refractory adrenocortical carcinoma. Journal Of Clinical Oncology 2012, 30: 4639-4639. DOI: 10.1200/jco.2012.30.15_suppl.4639.
- Haluska P, Menefee M, Plimack E, Rosenberg J, Northfelt D, LaVallee T, Huang W, Yu X, Viner J, LoRusso P. Safety, pharmacokinetics, and antitumor activity of MEDI-573, an investigational monoclonal antibody that targets IGF-I and IGF-II, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2012, 30: tps2618-tps2618. DOI: 10.1200/jco.2012.30.15_suppl.tps2618.
- Elias A, Richer J, LoRusso P, Peterson A, Steinberg J, Mordenti J, Lopez C, Hudis C, Traina T. MDV3100-08: A phase I open-label, dose-escalation study evaluating the safety, tolerability, and pharmacokinetics of MDV3100 in women with incurable breast cancer. Journal Of Clinical Oncology 2012, 30: tps668-tps668. DOI: 10.1200/jco.2012.30.15_suppl.tps668.
- Modi S, Elias A, LoRusso P, Samant M, Guardino E, Althaus B, Krop I. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. Journal Of Clinical Oncology 2012, 30: 528-528. DOI: 10.1200/jco.2012.30.15_suppl.528.
- Munster P, Miller K, Krop I, Dhindsa N, Reynolds J, Geretti E, Niyikiza C, Nielsen U, Hendriks B, Wickham T, Moyo V, LoRusso P. A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer. Journal Of Clinical Oncology 2012, 30: tps663-tps663. DOI: 10.1200/jco.2012.30.15_suppl.tps663.
- Ogita S, LoRusso P, Li J. Oral Chemotherapeutic Agents. 2012, 1-37. DOI: 10.1002/9780470921920.edm132.
- LoRusso P, Boerner S, Evelhoch J, Evelhoch J. Reply to E.S. Wang et al. Journal Of Clinical Oncology 2012, 30: 762-763. DOI: 10.1200/jco.2011.39.6895.
- Vankayala H, LoRusso P, Vaishampayan U. C-MET as a Novel Target for the Treatment of Renal Cell Carcinoma. 2012, 213-238. DOI: 10.1007/978-1-4614-2400-0_10.
- Haluska P, Huang J, Lam B, Liang M, Huang W, LoRusso P, Menefee M, LaVallee T, Yao Y, Viner J. MEDI-573 as a novel approach to IGF-1R and IR-A signaling inhibition by blocking IGF ligands: Phase I PK/PD, safety data, and disease linkage studies in breast cancer. Journal Of Clinical Oncology 2011, 29: 271-271. DOI: 10.1200/jco.2011.29.27_suppl.271.
- Garrett C, Siu L, El-Khoueiry A, Buter J, Rocha-Lima C, Marshall J, LoRusso P, Major P, Chemidlin J, Mokliatchouk O, Velasquez L, Hayes W, Feltquate D, Syed S, Ford S, Kollia G, Galbraith S, Nuyten D. Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy. British Journal Of Cancer 2011, 105: 44-52. PMID: 21629245, PMCID: PMC3137402, DOI: 10.1038/bjc.2011.182.
- Gupta M, LoRusso P, Burris H, Wang B, Joshi A, Tong Y, Chu Y, Girish S. Pharmacokinetic and pathophysiologic covariates influencing treatment outcomes with T-DM1 in patients with HER2-positive metastatic breast cancer (MBC). Journal Of Clinical Oncology 2011, 29: 633-633. DOI: 10.1200/jco.2011.29.15_suppl.633.
- Naing A, LoRusso P, Fu S, Hong D, Anderson P, Benjamin R, Ludwig J, Chen H, Doyle L, Kurzrock R. Cixutumumab combined with temsirolimus in patients with refractory Ewing’s sarcoma. Journal Of Clinical Oncology 2011, 29: 10031-10031. DOI: 10.1200/jco.2011.29.15_suppl.10031.
- Maitah M, Ali S, LoRusso P, Sarkar F, Gadgeel S. The role of GDC-0449, a hedgehog (Hh) pathway inhibitor, on epithelial–mesenchymal transition (EMT) in non-small cell lung cancer (NSCLC) cells lines and its effect on erlotinib and cisplatin. Journal Of Clinical Oncology 2011, 29: 10537-10537. DOI: 10.1200/jco.2011.29.15_suppl.10537.
- Camidge D, Bang Y, Kwak E, Shaw A, Iafrate A, Maki R, Solomon B, Ou S, Salgia R, Wilner K, Costa D, Shapiro G, LoRusso P, Stephenson P, Tang Y, Ruffner K, Clark J. Progression-free survival (PFS) from a phase I study of crizotinib (PF-02341066) in patients with ALK- positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2011, 29: 2501-2501. DOI: 10.1200/jco.2011.29.15_suppl.2501.
- Chiorean E, Sausville E, Heath E, Weise A, Gomez-Navarro J, Venkatakrishnan K, Sankoh S, Wu J, Corvez M, LoRusso P. Phase I study of TAK-285, an investigational HER2/EGFR inhibitor, in patients (pts) with advanced cancer: Updated results and assessment of human CSF distribution. Journal Of Clinical Oncology 2011, 29: 2538-2538. DOI: 10.1200/jco.2011.29.15_suppl.2538.
- LoRusso P, Ji J, Li J, Heilbrun L, Shapiro G, Sausville E, Boerner S, Smith D, Pilat M, Zhang J, Chen A, Nechiporchik N, Parchment R. Phase I study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib (ABT-888; V) in combination with irinotecan (CPT-11; Ir) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3000-3000. DOI: 10.1200/jco.2011.29.15_suppl.3000.
- Shapiro G, LoRusso P, Kwak E, Cleary J, Musib L, Jones C, de Crespigny A, Belvin M, McKenzie M, Gates M, Chan I, Bendell J. Clinical combination of the MEK inhibitor GDC-0973 and the PI3K inhibitor GDC-0941: A first-in-human phase Ib study testing daily and intermittent dosing schedules in patients with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3005-3005. DOI: 10.1200/jco.2011.29.15_suppl.3005.
- Cervantes A, Alsina M, Tabernero J, Infante J, LoRusso P, Shapiro G, Paz-Ares L, Falzone R, Hill J, Cehelsky J, White A, Toudjarska I, Bumcrot D, Meyers R, Hinkle G, Svrzikapa N, Sah D, Vaishnaw A, Gollob J, Burris H. Phase I dose-escalation study of ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement. Journal Of Clinical Oncology 2011, 29: 3025-3025. DOI: 10.1200/jco.2011.29.15_suppl.3025.
- Berlin J, Keedy V, Janne P, Yee L, Rizvi N, Jin X, Copigneaux C, Hettmann T, Beaupre D, LoRusso P. A first-in-human phase I study of U3-1287 (AMG 888), a HER3 inhibitor, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3026-3026. DOI: 10.1200/jco.2011.29.15_suppl.3026.
- Weekes C, LoRusso P, Ramakrishnan V, Shih L, Darbonne W, Hegde P, Xin Y, Yu R, Xiang H, Brachmann R, Patnaik A. A phase Ib study for MNRP1685A (anti-NRP1) administered intravenously with bevacizumab with or without paclitaxel to patients with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3050-3050. DOI: 10.1200/jco.2011.29.15_suppl.3050.
- Cho D, Heath E, Cleary J, Kwak E, Gandhi L, Lawrence D, Zack C, Teofilovici F, Bradley R, Karol M, Shapiro G, LoRusso P. A phase I dose-escalation study of the Hsp90 inhibitor ganetespib (STA-9090) administered twice weekly in patients with solid tumors: Updated report. Journal Of Clinical Oncology 2011, 29: 3051-3051. DOI: 10.1200/jco.2011.29.15_suppl.3051.
- Von Hoff D, LoRusso P, Demetri G, Weiss G, Shapiro G, Ramanathan R, Ware J, Raja R, Jin J, Levy G, Mazina K, Wagner A. A phase I dose-escalation study to evaluate GDC-0941, a pan-PI3K inhibitor, administered QD or BID in patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2011, 29: 3052-3052. DOI: 10.1200/jco.2011.29.15_suppl.3052.
- Sausville E, LoRusso P, Carducci M, Barker P, Agbo F, Oakes P, Senderowicz A. Phase I dose-escalation study of AZD7762 in combination with gemcitabine (gem) in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3058-3058. DOI: 10.1200/jco.2011.29.15_suppl.3058.
- Sarantopoulos J, Lenz H, LoRusso P, Shibata S, Kummar S, Mulkerin D, Ramanathan R, Mita M, O'Rourke P, Remick S, Goel S, Gutierrez M, Ramalingam S, Murgo A, Davies A, Mani S, Boni J, Shapiro M, Ivy S, Takimoto C. Phase I pharmacokinetic study of temsirolimus (CCI-779) in patients with advanced malignancies and normal and impaired liver function: An NCI Organ Dysfunction Working Group (ODWG) study. Journal Of Clinical Oncology 2011, 29: 3072-3072. DOI: 10.1200/jco.2011.29.15_suppl.3072.
- Dickson M, LoRusso P, Sausville E, Rao N, Kobayashi E, Kurman M, Akinaga S, Schwartz G. Open-label, sequential, ascending, multi-dose, phase I study of KW-2450 as monotherapy in subjects with previously treated advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3078-3078. DOI: 10.1200/jco.2011.29.15_suppl.3078.
- Messersmith W, LoRusso P, Cleary J, Dasari A, Zhang X, Shaik M, Courtney R, Randolph S, Shapiro G. A phase I dose-escalation study of the novel gamma secretase inhibitor PF-03084014 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2011, 29: 3100-3100. DOI: 10.1200/jco.2011.29.15_suppl.3100.
- Gadgeel S, Ruckdeschel J, Wozniak A, Chen W, Hackstock D, Galasso C, Burger A, Ivy S, LoRusso P, Edelman M. Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2011, 29: 7564-7564. DOI: 10.1200/jco.2011.29.15_suppl.7564.
- Darbonne W, Du X, Dhawan P, Hartley D, Tarrant J, Taylor H, Cain G, Shih L, Brachmann R, Phung Q, Weekes C, LoRusso P, Patnaik A, Xiang H, Ramakrishnan V. Mechanism for platelet reduction in anti-neuropilin-1 (MNRP1685A)–treated phase I patients. Journal Of Clinical Oncology 2011, 29: e13598-e13598. DOI: 10.1200/jco.2011.29.15_suppl.e13598.
- Sosman J, Adjei A, LoRusso P, Michael S, Dy G, Bowditch A, Chmielowski B, Lee S, Walker R, Faucette S, Izmailova E, Bozon V, Ribas A. First-in-human, multicenter, dose-escalation, phase I study of the investigational drug TAK-733, an oral MEK inhibitor, in patients (pts) with advanced nonhematologic malignancies and melanoma. Journal Of Clinical Oncology 2011, 29: tps145-tps145. DOI: 10.1200/jco.2011.29.15_suppl.tps145.
- Leal T, Remick S, Takimoto C, Ramanathan R, Davies A, Egorin M, Hamilton A, LoRusso P, Shibata S, Lenz H, Mier J, Sarantopoulos J, Mani S, Wright J, Ivy S, Neuwirth R, von Moltke L, Venkatakrishnan K, Mulkerin D. Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study. Cancer Chemotherapy And Pharmacology 2011, 68: 1439-1447. PMID: 21479634, PMCID: PMC3481841, DOI: 10.1007/s00280-011-1637-5.
- Burger A, LoRusso P. Breast Cancer Rationally Designed Therapies. 2011, 537-546. DOI: 10.1007/978-3-642-16483-5_6746.
- Venkatakrishnan K, Ramanathan R, Sarantopoulos J, Mulkerin D, Shibata S, Hamilton A, Dowlati A, Mani S, Rudek M, Ivy P, Takimoto C, Neuwirth R, Parasuraman S, LoRusso P. Pharmacokinetics and Safety of Bortezomib In Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction: Results of the Phase 1 National Cancer Institute Organ Dysfunction Working Group Study NCI 6432. Blood 2010, 116: 3975. DOI: 10.1182/blood.v116.21.3975.3975.
- Shimizu T, Tolcher A, LoRusso P, Papadopoulos K, Patnaik A, Smith L, Keegan M. 364 The first-in-human, first-in-class study of CUDC-101, a multi-targeted inhibitor of HDAC, EGFR, and HER2: A Phase I study in patients with advanced cancer. European Journal Of Cancer Supplements 2010, 8: 115. DOI: 10.1016/s1359-6349(10)72071-1.
- LoRusso P. 6 Challenges in clinical development of stem-cell therapy. European Journal Of Cancer Supplements 2010, 8: 10. DOI: 10.1016/s1359-6349(10)71709-2.
- Ratain M, Kelsey S, Janisch L, Smith J, Go N, Lin T, Maitland M, Kindler H, LoRusso P. 388 Imetelstat sodium (GRN163L), a telomerase inhibitor: tolerability, pharmacokinetics and pharmacodynamic activity using an intermittent once every four weeks dosing schedule in patients with advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 123. DOI: 10.1016/s1359-6349(10)72095-4.
- Menefee M, LoRusso P, Vin J, McDevitt J, Huang W, Lam B, Jin F, Chang Y, Haluska P. 3LB MEDI-573, a dual IGF-1/-2 neutralizing antibody, blocks IGF-1R and IR-A signaling and maintains glucose homeostasis in a Phase 1 study for advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 3-4. DOI: 10.1016/s1359-6349(10)71700-6.
- Tolcher A, Papadopolous K, Patniak A, Heath E, Weise A, Prokop T, Morrone S, Zanghi J, Keer H, LoRusso P. 381 Preliminary results of a dose escalation study of the Fibroblast Growth Factor (FGF) “trap” FP-1039 (FGFR1:Fc) in patients with advanced malignancies. European Journal Of Cancer Supplements 2010, 8: 121. DOI: 10.1016/s1359-6349(10)72088-7.
- Britten C, Adjei A, Millham R, Houk B, Wainberg Z, Guthrie T, Dy G, LoRusso P. 383 First-in-human study of PF-04691502, a small molecule oral dual inhibitor of PI3K and mTOR in patients with advanced cancer: Preliminary report on safety and pharmacokinetics. European Journal Of Cancer Supplements 2010, 8: 121-122. DOI: 10.1016/s1359-6349(10)72090-5.
- Nechiporchik N, Lieb K, Marquette L, Polin L, Peters G, Chen A, Ethier S, LoRusso P, Burger A. 189 Preclinical activity of the poly (ADP-ribose) polymerase (PARP) inhibitor ABT-888 in combination with irinotecan in ovarian and triple negative breast cancers. European Journal Of Cancer Supplements 2010, 8: 64. DOI: 10.1016/s1359-6349(10)71894-2.
- LoRusso P, Keedy V, Yee L, Oliveira M, Rizvi N, Berlin J, Jin X, Hettmann T, Copigneaux C, Beaupre D. 234 A phase 1, open-label, dose-finding study to assess the safety and tolerability of U3 1287 (AMG 888), a human monoclonal antibody targeting HER3 in patients with advanced solid tumors. European Journal Of Cancer Supplements 2010, 8: 76. DOI: 10.1016/s1359-6349(10)71939-x.
- 363 Dose of the molecularly targeted agents (MTA) in Phase 1 trials correlates with clinical benefitGupta S, Alqwasmi A, Hunsberger S, Rubinstein L, Ivy P, Royds R, LoRusso P. 363 Dose of the molecularly targeted agents (MTA) in Phase 1 trials correlates with clinical benefit. European Journal Of Cancer Supplements 2010, 8: 115. DOI: 10.1016/s1359-6349(10)72070-x.
- Fairbrother W, Wong H, Budha N, Blackwood B, Gould S, Erickson R, LoRusso P, Eckhardt S, Wagner A, Chan I. 82 Pharmacokinetic–pharmacodynamic modeling of the effect of GDC-0152, a selective antagonist of the inhibitor of apoptosis (IAP) proteins, on monocyte chemotactic protein-1 (MCP-1) indicates species differences in MCP-1 response. European Journal Of Cancer Supplements 2010, 8: 34. DOI: 10.1016/s1359-6349(10)71787-0.
- Fairbrother W, LoRusso P, Wagner A, Budha N, Darbonne W, Shin Y, Wong H, Chan I, Ware J, Eckhardt S. 393 Phase I pharmacokinetics and pharmacodynamics of GDC-0152, a novel IAP protein antagonist, administered to patients with locally advanced or metastatic malignancies. European Journal Of Cancer Supplements 2010, 8: 125. DOI: 10.1016/s1359-6349(10)72100-5.
- Heath E, Chiorean E, Sweeney C, Hodge J, Lager J, Forman K, Malburg L, Arumugham T, Dar M, Suttle A, Gainer S, LoRusso P. A Phase I Study of the Pharmacokinetic and Safety Profiles of Oral Pazopanib With a High‐Fat or Low‐Fat Meal in Patients With Advanced Solid Tumors. Clinical Pharmacology & Therapeutics 2010, 88: 818-823. PMID: 20980999, DOI: 10.1038/clpt.2010.199.
- Goncalves P, Sausville E, Edelman M, Pandya N, Houlehan M, Freeman B, Simmons H, Stallings J, Ptaszynski A, LoRusso P. A phase I study of ARRY-520 in solid tumors. Journal Of Clinical Oncology 2010, 28: 2570-2570. DOI: 10.1200/jco.2010.28.15_suppl.2570.
- Patel S, Lazar A, Mahoney S, Vaughn C, Gonzalez N, Papadopoulos N, Liu P, Infante J, LoRusso P, Kim K. Clinical responses to AZD6244 (ARRY-142886)-based combination therapy stratified by gene mutations in patients with metastatic melanoma. Journal Of Clinical Oncology 2010, 28: 8501-8501. DOI: 10.1200/jco.2010.28.15_suppl.8501.
- Minton S, LoRusso P, Lockhart A, Saif M, Krishnamurthi S, Pickett-Gies C, Wang Y, Guan S, Roben E, Stein M. A phase I study of MK-5108, an oral aurora A kinase inhibitor, in both monotherapy and in combination with docetaxel in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: e13026-e13026. DOI: 10.1200/jco.2010.28.15_suppl.e13026.
- Gomez-Roca C, Baey C, Olmos D, Berens A, Bigger E, LoRusso P, Rothenberg M, Kaye S, Pignon J, Soria J. An international pooled analysis identifying predictive factors associated with toxicities in phase I trials (Delphi). Journal Of Clinical Oncology 2010, 28: 2517-2517. DOI: 10.1200/jco.2010.28.15_suppl.2517.
- Von Hoff D, LoRusso P, Tibes R, Shapiro G, Weiss G, Ware J, Fredrickson J, Mazina K, Levy G, Wagner A. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: 2541-2541. DOI: 10.1200/jco.2010.28.15_suppl.2541.
- Egorin M, Kummar S, Sarantopoulos J, Shibata S, LoRusso P, Yerk M, Lin Y, Ivy S, Belani C, Ramalingam S. Phase I study of vorinostat for patients with advanced solid tumors and hepatic dysfunction: An NCI Organ Dysfunction Working Group (ODWG) study (NCI #8057). Journal Of Clinical Oncology 2010, 28: 2545-2545. DOI: 10.1200/jco.2010.28.15_suppl.2545.
- LoRusso P, Krop I, Burris H, Vukelja S, Miller K, Zheng M, Chu Y, Lu M, Amler L, Rugo H. Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy. Journal Of Clinical Oncology 2010, 28: 1016-1016. DOI: 10.1200/jco.2010.28.15_suppl.1016.
- Busaidy N, Kurzrock R, LoRusso P, Owens A, Chen H, Doyle L, Zhang J, Lawhorn K, Chandhasin C, Naing A. Hyperglycemia, hypertriglyceridemia, and hypercholesterolemia in a phase I trial of the combination of an mTOR inhibitor and IGF-1 receptor inhibitor. Journal Of Clinical Oncology 2010, 28: 2597-2597. DOI: 10.1200/jco.2010.28.15_suppl.2597.
- Naing A, LoRusso P, Gupta S, Benjamin R, Rohren E, Chen H, Doyle L, Berry D, Amin H, Kurzrock R. Dual inhibition of IGFR and mTOR pathways. Journal Of Clinical Oncology 2010, 28: 3007-3007. DOI: 10.1200/jco.2010.28.15_suppl.3007.
- Brana I, LoRusso P, Baselga J, Heath E, Patnaik A, Gendreau S, Laird A, Papadopoulos K. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765 (SAR245409), a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced malignancies. Journal Of Clinical Oncology 2010, 28: 3030-3030. DOI: 10.1200/jco.2010.28.15_suppl.3030.
- Liu G, LoRusso P, Heath E, Bruce J, Traynor A, Pilat M, Breazna A, Tortorici M, Shalinsky D, Ricart A. Pharmacodynamically guided dose selection of PF-00337210, a VEGFR2 tyrosine kinase (TK) inhibitor, in a phase I study. Journal Of Clinical Oncology 2010, 28: 3033-3033. DOI: 10.1200/jco.2010.28.15_suppl.3033.
- Gollob J, Infante J, Shapiro G, LoRusso P, Dezube B, Heymach J, Cehelsky J, Falzone R, Vaishnaw A, Burris H. Interim safety and pharmacodynamic results for ALN-VSP02, a novel RNAi therapeutic for solid tumors with liver involvement. Journal Of Clinical Oncology 2010, 28: 3042-3042. DOI: 10.1200/jco.2010.28.15_suppl.3042.
- Moldovan C, Soria J, LoRusso P, Guthrie T, Song C, Nguyen L, Martini J, Infante J, Burris H. A phase I safety and pharmacokinetic (PK) study of the PI3K inhibitor XL147 (SAR245408) in combination with erlotinib in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: 3070-3070. DOI: 10.1200/jco.2010.28.15_suppl.3070.
- Sharma S, Sausville E, LoRusso P, Vogelzang N, Samlowski W, Carter J, Forman K, Bever S, Messmann R. A phase I study of EC0225 administered weeks 1 and 2 of a 4-week cycle. Journal Of Clinical Oncology 2010, 28: 3082-3082. DOI: 10.1200/jco.2010.28.15_suppl.3082.
- Cleary J, Heath E, Kwak E, Dezube B, Gandhi L, Zack C, Bradley R, Vukovic V, Shapiro G, LoRusso P. A phase I dose-escalation study of the Hsp90 inhibitor STA-9090 administered twice weekly in patients with solid tumors. Journal Of Clinical Oncology 2010, 28: 3083-3083. DOI: 10.1200/jco.2010.28.15_suppl.3083.
- Harb W, Conley B, LoRusso P, Sausville E, Heath E, Chandana S, Hamm M, Carter J, Perez W, Messmann R. A phase I study of the folate-targeted conjugate EC0489 in patients with refractory or advanced metastatic cancer. Journal Of Clinical Oncology 2010, 28: 3088-3088. DOI: 10.1200/jco.2010.28.15_suppl.3088.
- Chawla S, Tabernero J, Kindler H, Chiorean E, LoRusso P, Hsu M, Haddad V, Bach B, Baselga J. Phase I evaluation of the safety of conatumumab (AMG 655) in combination with AMG 479 in patients (pts) with advanced, refractory solid tumors. Journal Of Clinical Oncology 2010, 28: 3102-3102. DOI: 10.1200/jco.2010.28.15_suppl.3102.
- Heath E, LoRusso P, Kurzrock R, Falchook G, Maroun C, Drouin M, Juretic M, Martell R, Besterman J, Wheler J. A phase I study of oral administration of MGCD265 in patients with advanced malignancies (study 265-102). Journal Of Clinical Oncology 2010, 28: 3108-3108. DOI: 10.1200/jco.2010.28.15_suppl.3108.
- Patnaik A, Weekes C, Hegde P, Xin Y, Yu R, Xiang H, Brachmann R, LoRusso P. A phase Ib study to evaluate the fully human monoclonal antibody MNRP1685A (anti-NRP1) administered intravenously in combination with bevacizumab with or without weekly paclitaxel in patients with advanced solid tumors. Journal Of Clinical Oncology 2010, 28: tps180-tps180. DOI: 10.1200/jco.2010.28.15_suppl.tps180.
- LoRusso P, Girish S, Burris H, Beeram M, Vukelja S, Modi S, Yi J, Wang B, Saad O, Gupta M. Population Pharmacokinetics of Trastuzumab-DM1, a First-in-Class HER2 Antibody-Drug Conjugate Given Every 3 Weeks (q3w) and Weekly (qw) to Patients with HER2-Positive Metastatic Breast Cancer (MBC). Cancer Research 2009, 69: 5099-5099. DOI: 10.1158/0008-5472.sabcs-09-5099.
- Krop I, LoRusso P, Miller K, Modi S, Yardley D, Rodriguez G, Agresta S, Zheng M, Amler L, Rugo H. A Phase II Study of Trastuzumab-DM1 (T-DM1), a Novel HER2 Antibody–Drug Conjugate, in HER2+ Metastatic Breast Cancer (MBC) Patients Previously Treated with Conventional Chemotherapy, Lapatinib and Trastuzumab. Cancer Research 2009, 69: 5090-5090. DOI: 10.1158/0008-5472.sabcs-09-5090.
- Demetri G, Russo P, MacPherson I, Wang D, Morgan J, Brunton V, Paliwal P, Agrawal S, Voi M, Evans T. Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors. Clinical Cancer Research 2009, 15: 6232-6240. PMID: 19789325, DOI: 10.1158/1078-0432.ccr-09-0224.
- LoRusso P, Zalupski M, Desai S, Burris H, Stella P, Xu J, Liu Q, Mookerjee B, Shields A. 1242 Cediranib in combination with mFOLFOX6: results from the cohort expansion phase of a two-part Phase I study. European Journal Of Cancer Supplements 2009, 7: 133. DOI: 10.1016/s1359-6349(09)70454-9.
- Von Hoff D, Wagner A, LoRusso P, Tibes R, Jin J, Ware J, Yan Y, Derynck M, Dolezal M, Demetri G. 1205 A first-in-human Phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumours. European Journal Of Cancer Supplements 2009, 7: 122. DOI: 10.1016/s1359-6349(09)70417-3.
- Vonderheide R, LoRusso P, Khalil M, Heath E, Khaira D, Soulieres D, Dorazio P, Mariani G, Usari T, Domchek S. Tremelimumab in combination with exemestane as novel immunotherapy for patients with advanced breast cancer. Journal Of Clinical Oncology 2009, 27: 3034-3034. DOI: 10.1200/jco.2009.27.15_suppl.3034.
- Wagner A, Von Hoff D, LoRusso P, Tibes R, Mazina K, Ware J, Yan Y, Derynck M, Demetri G. A first-in-human phase I study to evaluate the pan-PI3K inhibitor GDC-0941 administered QD or BID in patients with advanced solid tumors. Journal Of Clinical Oncology 2009, 27: 3501-3501. DOI: 10.1200/jco.2009.27.15_suppl.3501.
- LoRusso P, Markman B, Tabernero J, Shazer R, Nguyen L, Heath E, Patnaik A, Papadopoulos K. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2009, 27: 3502-3502. DOI: 10.1200/jco.2009.27.15_suppl.3502.
- Liu G, LoRusso P, Goncalves P, Holen K, Traynor A, Zhang J, Hee B, Tortorici M, Shalinsky D, Ricart A. Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of PF-00337210, a highly selective VEGFR inhibitor. Journal Of Clinical Oncology 2009, 27: 3519-3519. DOI: 10.1200/jco.2009.27.15_suppl.3519.
- Hoban C, Hoering A, Synold T, Chung V, Gandara D, Schott A, Kingsbury L, Lew D, LoRusso P, Gadgeel S. Phase I evaluation of lapatinib and everolimus in patients with advanced malignancies: Southwest Oncology Group trial S0528. Journal Of Clinical Oncology 2009, 27: 3553-3553. DOI: 10.1200/jco.2009.27.15_suppl.3553.
- Heath E, Blumenschein G, Cohen R, LoRusso P, LoConte N, Kim S, Chao R, Wilding G. Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: Updated phase I study results. Journal Of Clinical Oncology 2009, 27: e14509-e14509. DOI: 10.1200/jco.2009.27.15_suppl.e14509.
- Hong D, LoRusso P, Kurzrock R, Maroun C, Mehran M, Drouin M, Martell R, Wheler J. Phase I study of MGCD265 administered intermittently to patients with advanced malignancies (Study 265–102). Journal Of Clinical Oncology 2009, 27: e14516-e14516. DOI: 10.1200/jco.2009.27.15_suppl.e14516.
- Naing A, LoRusso P, Mills G, Berry D, Doyle L, Rohren E, Burger A, Chen H, Busaidy N, Kurzrock R. Phase I study combining an IGFR inhibitor (IMC-A12) and an mTOR inhibitor (temsirolimus) in patients with solid tumors or lymphoma. Journal Of Clinical Oncology 2009, 27: e14535-e14535. DOI: 10.1200/jco.2009.27.15_suppl.e14535.
- Li J, Sha X, LoRusso P. Pharmacogenetics of a PARP inhibitor ABT-888 metabolic pathway. Journal Of Clinical Oncology 2009, 27: e14556-e14556. DOI: 10.1200/jco.2009.27.15_suppl.e14556.
- Gadgeel S, Wozniak A, Edelman M, Valdivieso M, Heilbrun L, Venkatramanamoorthy R, Shields A, LoRusso P, Hackstock D, Ruckdeschel J. Cediranib, a VEGF receptor 1, 2, and 3 inhibitor, and pemetrexed in patients (pts) with recurrent non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2009, 27: e19007-e19007. DOI: 10.1200/jco.2009.27.15_suppl.e19007.
- Vishnu P, Jasti P, Ding L, Heilbrun L, Venkatramanamoorthy R, LoRusso P, Heath E. Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan. Journal Of Clinical Oncology 2009, 27: e20626-e20626. DOI: 10.1200/jco.2009.27.15_suppl.e20626.
- LoRusso P, Burris H, Jones S, Fleming R, Koch K. In Reply. Journal Of Clinical Oncology 2009, 27: 316-317. DOI: 10.1200/jco.2008.20.0758.
- Ratain M, Smith J, Benedetti F, Elias L, LoRusso P. 438 POSTER Pharmacodynamics (PD) of GRN163L in a Phase I study in refractory, solid tumors. European Journal Of Cancer Supplements 2008, 6: 138. DOI: 10.1016/s1359-6349(08)72372-3.
- Phatak P, Daniels C, Shields A, Collins J, LoRusso P, Burger A. 468 POSTER The role of thymidine kinase and thymidylate synthase in the response of tumor cells to the suicide prodrug 2′-F-ara-deoxyuridine. European Journal Of Cancer Supplements 2008, 6: 150. DOI: 10.1016/s1359-6349(08)72402-9.
- Hurwitz H, LoRusso P, Shapiro G, Wolanksi A, Chemidlin J, Masson E, Syed S, Kollia G, Conlon K. 429 POSTER Phase 1 study of food effects on pharmacokinetics of brivanib alaninate in patients with advanced or metastatic solid tumors. European Journal Of Cancer Supplements 2008, 6: 135. DOI: 10.1016/s1359-6349(08)72363-2.
- Mita M, Spear M, Yee L, Papadopoulos K, Heath E, Pilat M, Romero O, Lloyd G, Mita A, LoRusso P. 42 POSTER NPI-2358 (a novel vascular disrupting agent) Phase 1 dose escalation trial with an RP2D cohort. European Journal Of Cancer Supplements 2008, 6: 17. DOI: 10.1016/s1359-6349(08)71974-8.
- LoRusso P, Sarker D, Von Hoff D, Tibes R, Derynck M, Ware J, Yan Y, Demetri G, de Bono J, Wagner A. 223 POSTER Pharmacokinetics and pharmacodynamic biomarkers for the pan-PI3K inhibitor GDC-0941: Initial Phase I evaluation. European Journal Of Cancer Supplements 2008, 6: 70-71. DOI: 10.1016/s1359-6349(08)72155-4.
- Krishnamurthi S, Goncalves P, Fox F, Hall N, Rowinsky E, Schwartz J, Youssoufian H, LoRusso P. 406 POSTER IMC-18F1, a recombinant human monoclonal antibody (MAb) against the vascular endothelial growth factor receptor-1 (VEGFR-1), in the treatment of patients (pts) with advanced solid malignancies: A Phase 1 study. European Journal Of Cancer Supplements 2008, 6: 127-128. DOI: 10.1016/s1359-6349(08)72340-1.
- Rudin C, Von Hoff D, LoRusso P, Vernillet L, Yauch R, Darbonne W, Mackey H, de Sauvage F, Low J, Reddy J. 355 POSTER Updated safety and efficacy data from a first-in-human, first-in-class, phase I study of Hedgehog pathway antagonist, GDC-0449. European Journal Of Cancer Supplements 2008, 6: 112-113. DOI: 10.1016/s1359-6349(08)72289-4.
- Rothenberg M, Poplin E, LoRusso P, Yu E, Schwartz J, Fox F, Mehnert J, Sandler A, Rowinsky E, Higano C. 554 POSTER Pharmacokinetic (PK) and pharmacodynamic (PD) results of Phase I studies of IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid malignancies. European Journal Of Cancer Supplements 2008, 6: 174-175. DOI: 10.1016/s1359-6349(08)72488-1.
- Markman B, LoRusso P, Patnaik A, Heath E, Laird A, van Leeuwen B, Papadopoulos K, Baselga J. 216 POSTER A phase I dose-escalation study of the safety, pharmacokinetics and pharmacodynamics of XL765, a novel inhibitor of PI3K and mTOR, administered orally to patients with solid tumors. European Journal Of Cancer Supplements 2008, 6: 68-69. DOI: 10.1016/s1359-6349(08)72148-7.
- Fracasso P, Ravaud A, Baggstrom M, LoRusso P, Jones D, Sguotti C, Urban P, Gao B, Medioni J. Patupilone combined with carboplatin in patients (pts) with advanced solid tumors: preliminary safety and activity results. Journal Of Clinical Oncology 2008, 26: 13544-13544. DOI: 10.1200/jco.2008.26.15_suppl.13544.
- Harper F, Heath E, Gleason M, LoRusso P, Albrecht T. Objective versus subjective predictors of patient clinical benefit from phase I treatment. Journal Of Clinical Oncology 2008, 26: 13526-13526. DOI: 10.1200/jco.2008.26.15_suppl.13526.
- Camacho L, Moulder S, LoRusso P, Blumenschein G, Bristow P, Kurzrock R, Fu S, Schlienger K, Bergstrom D. First in human phase I study of MK-2461, a small molecule inhibitor of c-Met, for patients with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 14657-14657. DOI: 10.1200/jco.2008.26.15_suppl.14657.
- Heath E, Blumenschein G, Cohen R, LoRusso P, LoConte N, Kim S, Chao R, Wilding G. Phase I study of sunitinib in combination with carboplatin (C) plus paclitaxel (P) in patients (pts) with advanced solid tumors (STs). Journal Of Clinical Oncology 2008, 26: 3565-3565. DOI: 10.1200/jco.2008.26.15_suppl.3565.
- Ratain M, Benedetti F, Janisch L, Khor S, Schilsky R, Cohen E, Maitland M, Elias L, LoRusso P. A phase I trial of GRN163L (GRN), a first-in-class telomerase inhibitor, in advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3581-3581. DOI: 10.1200/jco.2008.26.15_suppl.3581.
- Mahany J, Lewis N, Heath E, LoRusso P, Mita M, Rodon J, Tolcher A, Sherman B, Bradley C, Papadopoulos K. A phase IB study evaluating BSI-201 in combination with chemotherapy in subjects with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3579-3579. DOI: 10.1200/jco.2008.26.15_suppl.3579.
- Mita A, Yee L, Papadopoulos K, Heath E, Romero O, Lloyd G, Cropp G, Spear M, Mita M, LoRusso P. Phase I study of NPI-2358 (a novel vascular disrupting agent) in patients with solid tumors and lymphomas. Journal Of Clinical Oncology 2008, 26: 3525-3525. DOI: 10.1200/jco.2008.26.15_suppl.3525.
- Papadopoulos K, Markman B, Tabernero J, Patnaik A, Heath E, DeCillis A, Laird D, Aggarwal S, Nguyen L, LoRusso P. A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel PI3K inhibitor, XL765, administered orally to patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3510-3510. DOI: 10.1200/jco.2008.26.15_suppl.3510.
- LoRusso P, Rudin C, Borad M, Vernillet L, Darbonne W, Mackey H, DiMartino J, de Sauvage F, Low J, Von Hoff D. A first-in-human, first-in-class, phase (ph) I study of systemic Hedgehog (Hh) pathway antagonist, GDC-0449, in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2008, 26: 3516-3516. DOI: 10.1200/jco.2008.26.15_suppl.3516.
- Krishnamurthi S, LoRusso P, Goncalves P, Fox F, Rowinsky E, Schwartz J, Youssoufian H. Phase 1 study of weekly anti-vascular endothelial growth factor receptor-1 (VEGFR-1) monoclonal antibody IMC-18F1 in patients with advanced solid malignancies. Journal Of Clinical Oncology 2008, 26: 14630-14630. DOI: 10.1200/jco.2008.26.15_suppl.14630.
- Crown J, Burris H, Di Leo A, Jagiello-Gruszfeld A, Jones S, LoRusso P, Oliva C, Parikh R, Stein S, Koehler M. Tolerability of lapatinib in combination with taxanes (T) in 507 patients with breast cancer (BC). European Journal Of Cancer Supplements 2008, 6: 200. DOI: 10.1016/s1359-6349(08)70818-8.
- Ramanathan R, Egorin M, Takimoto C, Remick S, Doroshow J, LoRusso P, Mulkerin D, Grem J, Hamilton A, Murgo A, Potter D, Belani C, Hayes M, Peng B, Ivy S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 563-569. PMID: 18235115, DOI: 10.1200/jco.2007.11.0304.
- Gibbons J, Egorin M, Ramanathan R, Fu P, Mulkerin D, Shibata S, Takimoto C, Mani S, LoRusso P, Grem J, Pavlick A, Lenz H, Flick S, Reynolds S, Lagattuta T, Parise R, Wang Y, Murgo A, Ivy S, Remick S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 570-576. PMID: 18235116, DOI: 10.1200/jco.2007.13.3819.
- LoRusso P, Bekele B, Boerner S, Davis D, Evelhoch J, Herbst R. Chapter 47 Phase 1 Trials Today. 2008, 553-570. DOI: 10.1016/b978-141603703-3.10047-0.
- Aaronson S, Abbruzzese J, Abel E, Anderson K, Arrick B, Bafico A, Barbash O, Bast R, Baylin S, Bekele B, Bertino J, Boerner S, Bommer G, Borden E, Buchstaller J, Buetow K, Burman K, Calin G, Campisi J, Caprioli R, Carroll P, Chaurand P, Ashley J, Cleveland J, Collins J, Cortes J, Costello J, Cox J, Croce C, D'Andrea A, Davis D, Deberardinis R, Demasi J, Diehl J, Digiovanni J, Dorsey F, Egeblad M, Ekmekcioglu S, Evelhoch J, Fearon E, Febbo P, Feng Z, Fletcher C, Frankel A, Friedman D, Fury M, Gambhir S, Gazdar A, Girard L, Glick A, Gonzalez-Angulo A, Gray J, Greene K, Grimm E, Grumolato L, Guertin D, Hait W, Havrda M, Hennessy B, Herbst R, Houghton A, Houghton P, Howley P, Hu W, Hwu P, Israel M, Jacks T, Jorgensen C, Kantarjian H, Keith B, Kelsen D, Korn W, Kundra P, Kurzrock R, Lee J, Levine A, Li L, Lippman S, Littlepage L, Liu Y, Look T, Lorusso P, Malkin D, Margolin J, Matrisian L, Mccormick F, Mendelsohn J, Merghoub T, Mills G, Minna J, Morrison S, Morton C, Neckers L, Nevins J, Okino S, Pardoll D, Pawson T, Payne E, Pfister D, Polsky D, Poplack D, Posada J, Powis G, Quintana E, Quintás-Cardama A, Rabin K, Reimann J, Rubin E, Sabatini D, Sato M, Sausville E, Sen G, Shah M, Shames D, Shoemaker R, Sikic B, Silverman R, Simon M, Spellman P, Steeves M, Thompson C, Tonon G, Weinberg R, Welch D, Werb Z, Winslow M, Woodward W, Xiong H, Yaghoubi S, Yuspa S. List of Contributing Authors. 2008, vii-xiii. DOI: 10.1016/b978-141603703-3.10061-5.
- Mita A, Wang D, Takimoto C, Martin D, Nguyen L, Rasmussen E, Storgard C, LoRusso P. 708 POSTER AMG 386, a first-in-class, selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. European Journal Of Cancer Supplements 2007, 5: 109-110. DOI: 10.1016/s1359-6349(07)70507-4.
- Vaishampayan U, Sausville E, Horiba M, Quinn M, Heilbrun L, Burger A, Ivy P, Li J, Lorusso P. Phase I trial of intravenous 17-allylaminogeldanamycin (A) and oral sorafenib (B) in pretreated advanced malignancy: Plasma Hsp90α induction correlates with clinical benefit. Journal Of Clinical Oncology 2007, 25: 3531-3531. DOI: 10.1200/jco.2007.25.18_suppl.3531.
- Shields A, Heath E, DeLuca P, Pilat M, Wozniak A, Gadgeel S, Puchalski T, Xu J, Liu Q, LoRusso P. AZD2171 in combination with various anticancer regimens: Follow-up results of a phase I multi-cohort study. Journal Of Clinical Oncology 2007, 25: 3544-3544. DOI: 10.1200/jco.2007.25.18_suppl.3544.
- O’Dwyer P, LoRusso P, DeMichele A, Gupta V, Barbi A, Dials H, Chen I, Courtney R, Wilner K, Schwartz G. A phase I dose escalation trial of a daily oral CDK 4/6 inhibitor PD-0332991. Journal Of Clinical Oncology 2007, 25: 3550-3550. DOI: 10.1200/jco.2007.25.18_suppl.3550.
- Wang D, Heath E, Powell A, Chaperon T, LaGrone F, LoRusso P. Barriers to phase I clinical trial protocol IRB approval at KCI. Journal Of Clinical Oncology 2007, 25: 9080-9080. DOI: 10.1200/jco.2007.25.18_suppl.9080.
- LoRusso P, Hong D, Heath E, Kurzrock R, Wang D, Hsu M, Goyal L, Wiezorek J, Storgard C, Herbst R. First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3534-3534. DOI: 10.1200/jco.2007.25.18_suppl.3534.
- Garrett C, Siu L, Giaccone G, El-Khoueiry A, Marshall J, LoRusso P, Velasquez L, Kollia G, He P, Feltquate D. A phase I study of BMS-582664 (brivanib alaninate), an oral dual inhibitor of VEGFR and FGFR tyrosine kinases, in combination with full-dose cetuximab in patients (pts) with advanced gastrointestinal malignancies (AGM) who failed prior therapy. Journal Of Clinical Oncology 2007, 25: 14018-14018. DOI: 10.1200/jco.2007.25.18_suppl.14018.
- Mita A, Wang D, Takimoto C, Malseed E, Nguyen L, Rasmussen E, Storgard C, LoRusso P. AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 14033-14033. DOI: 10.1200/jco.2007.25.18_suppl.14033.
- Spear M, LoRusso P, Tolcher A, Lin C, Wang D, Heath E, Lloyd G, Cropp G, Papadopoulos K. A phase 1 dynamic accelerated titration dose escalation study of the vascular disrupting agent NPI-2358. Journal Of Clinical Oncology 2007, 25: 14097-14097. DOI: 10.1200/jco.2007.25.18_suppl.14097.
- Wagner L, Lai S, Aneja M, Lorusso P, Perez-Soler R, O’Brien B, Patel J, Lacouture M. Development of a functional assessment of side-effects to therapy (FAST) questionnaire to assess dermatology-related quality of life in patients treated with EGFR inhibitors (EGFRI): The FAST-EGFRI. Journal Of Clinical Oncology 2007, 25: 19532-19532. DOI: 10.1200/jco.2007.25.18_suppl.19532.
- Slapak C, LoRusso P, Mendelson D, Sykes A, De Alwis D, Wagner M, Ilaria R, Gordon M. Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 2542-2542. DOI: 10.1200/jco.2007.25.18_suppl.2542.
- Sausville E, LoRusso P, Quinn M, Forman K, Leamon C, Morganstern D, Bever S, Messmann R. A phase I study of EC145 administered weeks 1 and 3 of a 4-week cycle in patients with refractory solid tumors. Journal Of Clinical Oncology 2007, 25: 2577-2577. DOI: 10.1200/jco.2007.25.18_suppl.2577.
- Higano C, Yu E, Whiting S, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Schwartz J. A phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-I receptor IgG1 monoclonal antibody, in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3505-3505. DOI: 10.1200/jco.2007.25.18_suppl.3505.
- Eder J, Heath E, Appleman L, Shapiro G, Wang D, Malburg L, Zhu A, Leader T, Wolanski A, LoRusso P. Phase I experience with c-MET inhibitor XL880 administered orally to patients (pts) with solid tumors. Journal Of Clinical Oncology 2007, 25: 3526-3526. DOI: 10.1200/jco.2007.25.18_suppl.3526.
- LoRusso P, Appleman L, Zhu A, Shapiro G, Fox L, Wolanski A, Hitchcock-Bryan S, Malburg L, Eder J. 404 POSTER Pharmacodynamics (pd) of x1880, a novel spectrum selective kinase inhibitor (SSKI), administered orally to patients (pts) with advanced solid tumors (AST). European Journal Of Cancer Supplements 2006, 4: 124. DOI: 10.1016/s1359-6349(06)70409-8.
- Higano C, Gordon M, LoRusso P, Fox F, Katz T, Roecker J, Rowinsky E, Youssoufian H. 648 POSTER A phase I dose-escalation study of weekly IMC-A12, a fully human insulin like growth factor-I receptor (IGF-IR) IgG1 monoclonal antibody (Mab), in patients (pts) with advanced cancer. European Journal Of Cancer Supplements 2006, 4: 195. DOI: 10.1016/s1359-6349(06)70653-x.
- Bröker L, Veltkamp S, Heath E, Gall H, Kuenen B, Voi M, Kayitalire L, Lorusso P, Schellens J, Giaccone G. 644 POSTER The novel oral taxane BMS275183 has a favorable activity and toxicity profile in a twice weekly schedule; Preliminary findings from an extended phase I trial. European Journal Of Cancer Supplements 2006, 4: 194. DOI: 10.1016/s1359-6349(06)70649-8.
- Morgan J, Demetri G, Wang D, MacPherson I, LoRusso P, van den Abbeele A, Brunton V, Luo R, Voi M, Evans T. 383 POSTER A Phase I Study of dasatinib, a Src and multi-kinase inhibitor, in patients (pts) with GIST and other solid tumors. European Journal Of Cancer Supplements 2006, 4: 118. DOI: 10.1016/s1359-6349(06)70388-3.
- Heath E, Alousi A, Eder J, Valdivieso M, Vasist L, Appleman L, Bhargava P, Colevas A, Lorusso P, Shapiro G. A phase I dose escalation trial of ispinesib (SB-715992) administered days 1–3 of a 21-day cycle in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 2026-2026. DOI: 10.1200/jco.2006.24.18_suppl.2026.
- Lorusso P, Heath E, Valdivieso M, Pilat M, Wozniak A, Gadgeel S, Shields A, Puchalski T, Ewesuedo R. Phase I evaluation of AZD2171, a highly potent and selective inhibitor of VEGFR signaling, in combination with selected chemotherapy regimens in patients with advanced solid tumors. Journal Of Clinical Oncology 2006, 24: 3034-3034. DOI: 10.1200/jco.2006.24.18_suppl.3034.
- Eder J, Appleman L, Heath E, Malburg L, Zhu A, Pilat M, Shapiro G, Lorusso P. A phase I study of a novel spectrum selective kinase inhibitor (SSKI), XL880, administered orally in patients (pts) with advanced solid tumors (STs). Journal Of Clinical Oncology 2006, 24: 3041-3041. DOI: 10.1200/jco.2006.24.18_suppl.3041.
- Gale R, Van Vugt A, Rosen L, Chang L, Lorusso P, Valdivieso M, Malburg L, Struck R, Morgan L. Phase-1 study of isophosphoramide mustard (IPM)-lysine in advanced cancers. Journal Of Clinical Oncology 2006, 24: 9524-9524. DOI: 10.1200/jco.2006.24.18_suppl.9524.
- Krop I, Kosh M, Fearen I, Savoie J, Dallob A, Matthews C, Stone J, Winer E, Freedman S, Lorusso P. Phase I pharmacokinetic (PK), and pharmacodynamic (PD) trial of the novel oral Notch inhibitor MK-0752 in patients (pts) with advanced breast cancer (BC) and other solid tumors. Journal Of Clinical Oncology 2006, 24: 10574-10574. DOI: 10.1200/jco.2006.24.18_suppl.10574.
- Wadler S, Loh E, Pilat M, Malburg L, Holloway S, Matthews N, Shackleton G, Valdivieso M, Lorusso P. A phase I trial of SR271425 given as a one hour infusion every 3 weeks to patients with advanced solid tumors. Journal Of Clinical Oncology 2005, 23: 2030-2030. DOI: 10.1200/jco.2005.23.16_suppl.2030.
- Broker L, Ruyter R, Voi M, Woo M, Astier L, Heath E, Lorusso P, Giaccone G. A phase I trial investigating a twice weekly administration of the oral taxane BMS-275183 in patients with advanced solid tumors. Journal Of Clinical Oncology 2005, 23: 2040-2040. DOI: 10.1200/jco.2005.23.16_suppl.2040.
- Woo M, Broker L, Pilat M, Malburg L, Cohen M, Griffin T, Valdivieso M, Giaccone G, Lorusso P. The effect of food on the pharmacokinetics of BMS-275183, a novel oral taxane, in patients with advanced solid malignancies. Journal Of Clinical Oncology 2005, 23: 2053-2053. DOI: 10.1200/jco.2005.23.16_suppl.2053.
- Kraut E, Fishman M, Lorusso P, Gordon M, Rubin E, Haas A, Fetterly G, Cullinan P, Dul J, Steinberg J. Final results of a phase I study of liposome encapsulated SN-38 (LE-SN38): Safety, pharmacogenomics, pharmacokinetics, and tumor response. Journal Of Clinical Oncology 2005, 23: 2017-2017. DOI: 10.1200/jco.2005.23.16_suppl.2017.
- Menon S, Whitfield L, Sadis S, Meyer M, Leopold J, Lorusso P, Krishnamurthi S, Rinehart J, Nabell L, Croghan G. Pharmacokinetics (PK) and pharmacodynamics (PD) of PD 0325901, a second generation MEK inhibitor after multiple oral doses of PD 0325901 to advanced cancer patients. Journal Of Clinical Oncology 2005, 23: 3066-3066. DOI: 10.1200/jco.2005.23.16_suppl.3066.
- Lorusso P, Krishnamurthi S, Rinehart J, Nabell L, Croghan G, Varterasian M, Sadis S, Menon S, Leopold J, Meyer M. A phase 1–2 clinical study of a second generation oral MEK inhibitor, PD 0325901 in patients with advanced cancer. Journal Of Clinical Oncology 2005, 23: 3011-3011. DOI: 10.1200/jco.2005.23.16_suppl.3011.
- Herbst RS, LoRusso P, Isobe T, Hurwitz HI. Angiogenesis pathway inhibitors. Cancer Chemotherapy And Biological Response Modifiers 2005, 22: 225-45. PMID: 16110614, DOI: 10.1016/s0921-4410(04)22010-5.
- El-Rayes B, LoRusso P. The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast Cancer. American Journal Of Cancer 2004, 3: 369-375. DOI: 10.2165/00024669-200403060-00004.
- LoRusso P. 460 Clinical development of AVE 8062 and ZD6126. European Journal Of Cancer Supplements 2004, 2: 139. DOI: 10.1016/s1359-6349(04)80468-3.
- LoRusso P, Fishman M, Kraut E, Gordon M, Elsayed Y, Steinberg J, Nieves J, Wanaski S, Dul J, Sherman J. 501 Prospective UGT1A1 genotyping in a phase I study of safety and pharmacokinetics of liposome encapsulated SN-38 (LE-SN38). European Journal Of Cancer Supplements 2004, 2: 153. DOI: 10.1016/s1359-6349(04)80509-3.
- Benson A, Rubin E, Beers S, Mucci-Lorusso P, Vermuelen W, Denis L, Compton L, Pavlov D, Rothenberg M. Phase I dose escalation and safety study of a semi-solid matrix (SSM) formulation of oral irinotecan and capecitabine tablets in patients with advanced solid tumors. Journal Of Clinical Oncology 2004, 22: 2042-2042. DOI: 10.1200/jco.2004.22.14_suppl.2042.
- Benson A, Rubin E, Beers S, Mucci-Lorusso P, Vermuelen W, Denis L, Compton L, Pavlov D, Rothenberg M. Phase I dose escalation and safety study of a semi-solid matrix (SSM) formulation of oral irinotecan and capecitabine tablets in patients with advanced solid tumors. Journal Of Clinical Oncology 2004, 22: 2042-2042. DOI: 10.1200/jco.2004.22.90140.2042.
- Burris H, Lorusso P, Jones S, Guthrie T, Orr J, Williams D, Hodge J, Bush M, Sabry J. Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 days. Journal Of Clinical Oncology 2004, 22: 2004-2004. DOI: 10.1200/jco.2004.22.14_suppl.2004.
- Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.14_suppl.2017.
- Alousi A, Parchment R, Boinpally R, Gadgeel S, Weigand R, McCormick J, Lorusso P. Phase I clinical trial of XK469 in patients with chemo-refractory solid tumors. Journal Of Clinical Oncology 2004, 22: 2020-2020. DOI: 10.1200/jco.2004.22.14_suppl.2020.
- Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancersSyed S, Beeram M, Takimoto C, Jakubowitz J, Kimura M, Ducharme M, Gadgeel S, De Jager R, Rowinsky E, Lorusso P. Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancers. Journal Of Clinical Oncology 2004, 22: 2028-2028. DOI: 10.1200/jco.2004.22.14_suppl.2028.
- Letrent S, Callegari F, Wong T, Burris H, Cohen R, Lorusso P, Papadimitrakopoulou V, Shapiro G, Griffin T, Decillis A. Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032. Journal Of Clinical Oncology 2004, 22: 2031-2031. DOI: 10.1200/jco.2004.22.14_suppl.2031.
- Sweeney C, Saif M, Lorusso P, Ducharme M, Demnati R, Danna M, Rowinsky E, Mita M, Dejager R, Takimoto C. A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunction. Journal Of Clinical Oncology 2004, 22: 2069-2069. DOI: 10.1200/jco.2004.22.14_suppl.2069.
- Kraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients. Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.14_suppl.2501.
- Rinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer. Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.14_suppl.3100.
- Burris H, Lorusso P, Jones S, Guthrie T, Orr J, Williams D, Hodge J, Bush M, Sabry J. Phase I trial of novel kinesin spindle protein (KSP) inhibitor SB-715992 IV days 1, 8, 15 q 28 days. Journal Of Clinical Oncology 2004, 22: 2004-2004. DOI: 10.1200/jco.2004.22.90140.2004.
- Takimoto C, Saif M, Lorusso P, Sweeney C, Ducharme M, Chu S, Schwartz G, Danna M, De Jager R, Rowinsky E. A pharmacokinetic (PK) dose escalation study of DX-8951f (DX) in adult cancer patients with hepatic dysfunction: A comparison of the NCI hepatic dysfunction criteria and the Child-Pugh classification. Journal Of Clinical Oncology 2004, 22: 2017-2017. DOI: 10.1200/jco.2004.22.90140.2017.
- Alousi A, Parchment R, Boinpally R, Gadgeel S, Weigand R, McCormick J, Lorusso P. Phase I clinical trial of XK469 in patients with chemo-refractory solid tumors. Journal Of Clinical Oncology 2004, 22: 2020-2020. DOI: 10.1200/jco.2004.22.90140.2020.
- Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancersSyed S, Beeram M, Takimoto C, Jakubowitz J, Kimura M, Ducharme M, Gadgeel S, De Jager R, Rowinsky E, Lorusso P. Phase I and Pharmacokinetics (PK) of DJ-927, an oral taxane, in patients (Pts) with advanced cancers. Journal Of Clinical Oncology 2004, 22: 2028-2028. DOI: 10.1200/jco.2004.22.90140.2028.
- Letrent S, Callegari F, Wong T, Burris H, Cohen R, Lorusso P, Papadimitrakopoulou V, Shapiro G, Griffin T, Decillis A. Evaluation of a novel RNA biomarker of CDK2 inhibition in phase 1 clinical trials with BMS-387032. Journal Of Clinical Oncology 2004, 22: 2031-2031. DOI: 10.1200/jco.2004.22.90140.2031.
- Sweeney C, Saif M, Lorusso P, Ducharme M, Demnati R, Danna M, Rowinsky E, Mita M, Dejager R, Takimoto C. A phase I study of DX 8951f (exatecan mesylate for injection) in patients with renal dysfunction. Journal Of Clinical Oncology 2004, 22: 2069-2069. DOI: 10.1200/jco.2004.22.90140.2069.
- Kraut E, Fishman M, Lorusso P, Steinberg J, Nieves J, Fetterly G, Darling I, Wanaski S, Dul J, Sherman J. Pharmacogenomic and pharmacokinetic assessment of liposome encapsulated SN-38 (LE-SN38) in advanced cancer patients. Journal Of Clinical Oncology 2004, 22: 2501-2501. DOI: 10.1200/jco.2004.22.90140.2501.
- Rinehart J, Rothermel J, Anderson J, Lorusso P. Phase I dose-escalation trial investigating the safety and tolerability of EPO906 plus gemcitabine in patients with advanced cancer. Journal Of Clinical Oncology 2004, 22: 3100-3100. DOI: 10.1200/jco.2004.22.90140.3100.
- Averbuch S, Wolf M, El‐Rayes B, LoRusso P. Clinical Development Issues. 2004, 287-306. DOI: 10.1002/047165616x.ch13.
- Corbett T, Polin L, LoRusso P, Valeriote F, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 2004, 99-123. DOI: 10.1007/978-1-59259-739-0_6.
- Burris H, LoRusso P, Jones S, McCormick J, Willcutt N, Hodge J, Bush P, Pandite L, Sabry J, Ho P. 570 A phase I study to determine the safety and pharmacokinetics of intravenous administration of SB715992 on a once weekly for three consecutive weeks schedule in patients with refractory solid tumors. European Journal Of Cancer Supplements 2003, 1: s172-s173. DOI: 10.1016/s1359-6349(03)90602-1.
- Budd G, Evelhoch J, Langmuir P, Veiero J, Shepherdson K, LoRusso P. 546 A phase I dose-escalation trial of ZD6126 administered as 5 daily dose every 3 weeks to patients with cancer refractory to other treatments. European Journal Of Cancer Supplements 2003, 1: s165. DOI: 10.1016/s1359-6349(03)90578-7.
- Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. Journal Of Clinical Oncology 2002, 20: 110-24. PMID: 11773160, DOI: 10.1200/jco.2002.20.1.110.
- Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.
- LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. DOI: 10.1053/sonc.2001.25437.
- LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. PMID: 11544572, DOI: 10.1016/s0093-7754(01)90228-3.
- Albanell J, Rojo F, Averbuch S, Feyereislova A, Herbst R, LoRusso P, Rischin D, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the specific oral EGFR tyrosine kinase inhibitor (EGFR-TKI) zd1839 (‘Iressa’) in skin from cancer patients participating in phase I trials: histopathological and molecular consequences of receptor inhibition. European Journal Of Cancer 2001, 37: s159. DOI: 10.1016/s0959-8049(01)81071-6.
- Prakash S, Foster B, Meyer M, Wozniak A, Heilbrun L, Flaherty L, Zalupski M, Radulovic L, Valdivieso M, LoRusso P. Chronic Oral Administration of CI-994: A Phase I Study. Investigational New Drugs 2001, 19: 1-11. PMID: 11291827, DOI: 10.1023/a:1006489328324.
- Kris M, Herbst R, Rischin D, LoRusso P, Baselga J, Hammond L, Feyereislova A, Ochs J, Averbuch S. Objective regressions in non-small cell lung cancer patients treated in Phase I trials of oral ZD1839 (IressaTM), a selective tyrosine kinase inhibitor that blocks the epidermal growth factor receptor (EGFR). Lung Cancer 2000, 29: 72. DOI: 10.1016/s0169-5002(00)80233-0.
- Shields A, Philip P, LoRusso P, Ferris A, Zalupski M. Phase II study of CI-958 in colorectal cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 162-164. PMID: 9923823, DOI: 10.1007/s002800050878.
- Blum J, Jones S, Buzdar A, LoRusso P, Kuter I, Vogel C, Osterwalder B, Burger H, Brown C, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. Journal Of Clinical Oncology 1999, 17: 485-93. PMID: 10080589, DOI: 10.1200/jco.1999.17.2.485.
- Corbett T, Panchapor C, Polin L, Lowichik N, Pugh S, White K, Kushner J, Meyer J, Czarnecki J, Chinnukroh S, Edelstein M, LoRusso P, Heilbrun L, Horwitz J, Grieshaber C, Perni R, Wentland M, Coughlin S, Elenbaas S, Philion R, Rake J. Preclinical efficacy of thioxanthone SR271425 against transplanted solid tumors of mouse and human origin. Investigational New Drugs 1999, 17: 17-27. PMID: 10555119, DOI: 10.1023/a:1006267517726.
- Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan DetroitSimon M, Brown D, Du W, LoRusso P, Kellogg C. Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit. American Journal Of Clinical Oncology 1999, 22: 42-46. PMID: 10025379, DOI: 10.1097/00000421-199902000-00011.
- Mucci‐LoRusso P, Berman B, Silberstein P, Citron M, Bressler L, Weinstein S, Kaiko R, Buckley B, Reder R. Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study. European Journal Of Pain 1998, 2: 239-249. PMID: 15102384, DOI: 10.1016/s1090-3801(98)90020-9.
- Corbett T, LoRusso P, Demchick L, Simpson C, Pugh S, White K, Kushner J, Polin L, Meyer J, Czarnecki J, Heilbrun L, Horwitz J, Gross J, Behrens C, Harrison B, McRipley R, Trainor G. Preclinical antitumor efficacy of analogs of XK469: sodium-(2-[4-(7-chloro-2-quinoxalinyloxy)phenoxy]propionate. Investigational New Drugs 1998, 16: 129-139. PMID: 9848576, DOI: 10.1023/a:1006174622061.
- Zalupski M, Shields A, Philip P, Kraut M, LoRusso P, Heilbrun L, Vaitkevicius V. Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma. Investigational New Drugs 1998, 16: 93-96. PMID: 9740550, DOI: 10.1023/a:1006087114621.
- Zalupski M, Philip P, LoRusso P, Shields A. Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma. Cancer Chemotherapy And Pharmacology 1997, 40: 225-227. PMID: 9219505, DOI: 10.1007/s002800050650.
- Polin L, Valeriote F, White K, Panchapor C, Pugh S, Knight J, LoRusso P, Hussain M, Liversidge E, Peltier N, Golakoti T, Patterson G, Moore R, Corbett T. Treatment of human prostate tumors PC-3 and TSU-PR1 with standard and investigational agents in SCID mice. Investigational New Drugs 1997, 15: 99-108. PMID: 9220288, DOI: 10.1023/a:1005856605726.
- Corbett T, Valeriote F, LoRusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 1997, 75-99. DOI: 10.1007/978-1-4615-8152-9_5.
- LoRusso P, Demchik L, Foster B, Knight J, Bissery M, Polin L, Leopold W, Corbett T. Preclinical antitumor activity of CI-994. Investigational New Drugs 1996, 14: 349-356. PMID: 9157069, DOI: 10.1007/bf00180810.
- Corbett T, Valeriote F, Demchik L, Polin L, Panchapor C, Pugh S, White K, Knight J, Jones J, Jones L, LoRusso P, Foster B, Wiegand R, Lisow L, Golakoti T, Heltzel C, Ogino J, Patterson G, Moore R. Preclinical anticancer activity of cryptophycin-8. Journal Of Experimental Therapeutics And Oncology 1996, 1: 95-108. PMID: 9414393.
- Djuric Z, Heilbrun L, Simon M, Smith D, Luongo D, LoRusso P, Martino S. Levels of 5‐hydroxymethyl‐2′‐deoxyuridine in DNA from blood as a marker of breast cancer. Cancer 1996, 77: 691-696. PMID: 8616761, DOI: 10.1002/(sici)1097-0142(19960215)77:4<691::aid-cncr15>3.0.co;2-w.
- Foster B, LoRusso P, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L, Kasunic D, Earhart R, Baker L. Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks. Investigational New Drugs 1995, 13: 321-326. PMID: 8824350, DOI: 10.1007/bf00873138.
- LoRusso P, Foster B, Poplin E, McCormick J, Kraut M, Flaherty L, Heilbrun L, Valdivieso M, Baker L. Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934). Clinical Cancer Research 1995, 1: 1487-93. PMID: 9815948.
- LoRusso P, Demchik L, Dan M, Polin L, Gross J, Corbett T. Comparative efficacy of DMP 840 against mouse and human solid tumor models. Investigational New Drugs 1995, 13: 195-203. PMID: 8729946, DOI: 10.1007/bf00873800.
- Corbett T, Valeriote F, Lorusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lowichik N, Biernat L, Foster B, Wozniak A, Lisow L, Valdivieso M, Baker L, Leopold W, Sebolt J, Bissery M, Mattes K, Dzubow J, Rake J, Perni R, Wentland M, Coughlin S, Shaw J, Liversidge G, Liversidge E, Bruno J, Sarpotdar P, Moore R, Patterson G. Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents. Pharmaceutical Biology 1995, 33: 102-122. DOI: 10.3109/13880209509067092.
- Valeriote F, Corbett T, Lorusso P, Moore R, Scheuer P, Patterson G, Paul V, Grindey G, Bonjouklian R, Pearce H, Suffness M. Discovery of Anticancer Agents from Natural Products. Pharmaceutical Biology 1995, 33: 59-66. DOI: 10.3109/13880209509067088.
- Corbett T, Lowichik N, Pugh S, Polin L, Panchapor C, White K, Knight J, Demchik L, Jones J, Jones L, Biernat L, Lorusso P, Foster B, Heilbrun L, Rake J, Mattes K, Perni R, Powles R, Hlavac A, Wentland M, Coughlin S, Baker L, Valeriote F. Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues. Expert Opinion On Investigational Drugs 1994, 3: 1281-1292. DOI: 10.1517/13543784.3.12.1281.
- Poplin E, LoRusso P, Lokich J, Gullo J, Leming P, Schulz J, Veach S, McCulloch W, Baker L, Schein P. Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer. Cancer Chemotherapy And Pharmacology 1994, 33: 415-419. PMID: 8306416, DOI: 10.1007/bf00686271.
- Visscher D, Sarkar F, LoRusso P, Sakr W, Ottosen S, Wykes S, Crissman J. Immunohistologic evaluation of invasion-associated proteases in breast carcinoma. Modern Pathology 1993, 6: 302-6. PMID: 8346178.
- Corbett T, Valeriote F, Polin L, Panchapor C, Pugh S, White K, Lowichik N, Knight J, Bissery M, Wozniak A, LoRusso P, Biernat L, Polin D, Knight L, Biggar S, Looney D, Demchik L, Jones J, Jones L, Blair S, Palmer K, Essenmacher S, Lisow L, Mattes K, Cavanaugh P, Rake J, Baker L. Discovery of Solid Tumor Active Agents Using a Soft-Agar-Colony-Formation Disk-Diffusion-Assay. Developments In Oncology 1992, 35-87. DOI: 10.1007/978-1-4615-3492-1_3.
- LoRusso P, Wozniak A, Polin L, Capps D, Leopold W, Werbel L, Biernat L, Dan M, Corbett T. Antitumor efficacy of PD115934 (NSC 366140) against solid tumors of mice. Cancer Research 1990, 50: 4900-5. PMID: 2165850.
- Mucci-LoRusso P, Polin L, Biernat L, Valeriote F, Corbett T. Activity of datelliptium acetate (NSC 311152; SR 95156A) against solid tumors of mice. Investigational New Drugs 1990, 8: 253-261. PMID: 2177044, DOI: 10.1007/bf00171834.
- LoRusso P, Pazdur R, Redman B, Kinzie J, Vaitkevicius V. Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin. American Journal Of Clinical Oncology 1989, 12: 486-490. PMID: 2686394, DOI: 10.1097/00000421-198912000-00005.
- Mucci-LoRusso P, Polin L, Bissery M, Valeriote F, Plowman J, Luk G, Corbettv T. Activity of batracylin (NSC-320846) against solid tumors of mice. Investigational New Drugs 1989, 7: 295-306. PMID: 2557298, DOI: 10.1007/bf00173759.
- Corbett T, Bissery M, Mucci-LoRusso P, Polin L. 5-Fluorouracil containing combinations in murine tumor systems. Investigational New Drugs 1989, 7: 37-49. PMID: 2661481, DOI: 10.1007/bf00178190.
- Lorusso P, Tapazoglou E, Kish J, Ensley J, Cummings G, Kelly J, Al‐Sarraf M. Chemotherapy for paranasal sinus carcinoma. A 10‐year experience at Wayne state university. Cancer 1988, 62: 1-5. PMID: 2454717, DOI: 10.1002/1097-0142(19880701)62:1<1::aid-cncr2820620102>3.0.co;2-f.
Departments and Programs
Locations
- Smilow Cancer Hospital Phase I Unit55 Park StreetSte First FloorNew Haven, CT 06511
- Smilow Cancer Hospital Phase I Unit55 Park StreetSte First FloorNew Haven, CT 06511