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Phase III

Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

  • Study HIC#:2000038947
  • Last Updated:02/26/2025

The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.

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    Eligibility Criteria

    Inclusion Criteria

    • Have histologically or cytologically confirmed PDAC that is metastatic.
    • Have not been previously treated for PDAC in the metastatic setting.
    • Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
    • Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and adverse events (AEs) have resolved to Grade 1 or less before randomization.
    • Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade ≤ 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction.
    • Eastern Cooperative Oncology Group PS of 0 to 1.
    • At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.

    Exclusion Criteria

    • Previously treated for locally advanced, unresectable PDAC.
    • History of brain metastases or leptomeningeal metastases.
    • Prior treatment with a CD73 antagonist or inhibitor.
    • Underlying medical or psychiatric conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: