Status:
ACTIVE_NOT_RECRUITING
Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Lead Sponsor:
Arcus Biosciences, Inc.
Collaborating Sponsors:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Metastatic Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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 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
- Previously treated for locally advanced, unresectable PDAC.
- History of brain metastases or leptomeningeal metastases.
- Prior treatment with a CD73 antagonist or inhibitor.
- Underlying medical 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.
Key Trial Info
Start Date :
December 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2030
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT06608927
Start Date
December 13 2024
End Date
November 30 2030
Last Update
December 23 2025
Active Locations (125)
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1
Mayo Clinic Arizona - Phoenix Campus
Phoenix, Arizona, United States, 85054
2
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
University of California San Diego Health
La Jolla, California, United States, 92093
4
Cancer & Blood Specialty Clinic - Los Alamitos
Los Alamitos, California, United States, 90720