A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma.
Primary:
- To compare OS of quemliclustat + NP-Gem versus placebo + NP-Gem in all randomized patients.
- To compare progression-free survival (PFS) of quemliclustat + NP-Gem versus placebo + NP-Gem in all randomized patients.
Secondary:
- To assess additional measures of clinical activity in all randomized patients.
- To assess the safety and tolerability of quemliclustat or placebo in combination with NP Gem in all randomized patients.
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers University
Inclusion Criteria: - Have histologically or cytologically confirmed PDAC that is metastatic. - Have not been previously treated for PDAC in the metastatic setting. 1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. 2. 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. 3. 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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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