Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT06608927
- Lead Sponsor
- Arcus Biosciences, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 610
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B (Comparator Arm) Nab-paclitaxel Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm B (Comparator Arm) Gemcitabine Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm A (Experimental Arm) Quemliclustat Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm A (Experimental Arm) Nab-paclitaxel Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm A (Experimental Arm) Gemcitabine Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm B (Comparator Arm) Placebo Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 72 months
- Secondary Outcome Measures
Name Time Method Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 Up to 72 months Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1 Up to 72 months The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Up to 72 months Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 Up to 72 months Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1 Up to 72 months
Trial Locations
- Locations (133)
University of California San Diego Health
🇺🇸La Jolla, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
USOR - Illinois Cancer Specialists - Arlington Heights
🇺🇸Arlington Heights, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Michigan Rogel Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of New Mexico Comprehensive Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Clinical Research Alliance
🇺🇸New Hyde Park, New York, United States
Memorial Sloan-Kettering Cancer Center - New York - Rockefeller Outpatient Pavilion
🇺🇸New York, New York, United States
Scroll for more (123 remaining)University of California San Diego Health🇺🇸La Jolla, California, United States