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
A
Ashiq Masood
Primary Investigator
Administratively Closed
18 years - 100 years
All
Phase
3
10 participants needed
3 Locations
Brief description of study
What is the purpose of this study?
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.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
Experimental Arm A (Experimental Arm): Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
Placebo Comparator Arm B (Comparator Arm): Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Metastatic Pancreatic Ductal Adenocarcinoma, Cancer
-
Age: 18 years - 100 years
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Gender: All
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.
Updated on
03 Sep 2025.
Study ID: CTO-PRISM-1, 24484
