Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Trial Status: closed to accrual
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.
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 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 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.
Additional locations may be listed on ClinicalTrials.gov for NCT06608927.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not AvailableCalifornia
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not AvailableLos Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Lisa Yonemoto
Phone: 310-825-4477
Email: lyonemoto@mednet.ucla.edu
Colorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Contact: Michael D. Wacker
Phone: 303-903-2025
Denver
University of Colorado
Status: Approved
Contact: Katherine Daniels
Phone: 303-724-9848
UCHealth - Cherry Creek
Status: Active
Contact: Michael D. Wacker
Phone: 303-903-2025
Highlands Ranch
UCHealth Highlands Ranch Hospital
Status: Active
Contact: Katherine Daniels
Phone: 303-724-9848
Lone Tree
UCHealth Lone Tree Health Center
Status: Active
Contact: Michael D. Wacker
Phone: 303-903-2025
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not AvailableFairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not AvailableGreenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not AvailableGuilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not AvailableNew Haven
Yale University
Status: Active
Name Not AvailableSmilow Cancer Center/Yale-New Haven Hospital
Status: Active
Name Not AvailableNorth Haven
Yale-New Haven Hospital North Haven Medical Center
Status: Active
Name Not AvailableStamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not AvailableTorrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableWaterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Name Not AvailableWaterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not AvailableGeorgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableIndiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Status: Active
Name Not AvailableNebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not AvailableNew Mexico
Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not AvailableNew York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not AvailableLaura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableRochester
University of Rochester
Status: Active
Name Not AvailableOklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not AvailablePennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableHouston
M D Anderson Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase III
Trial Typetreatment
Lead OrganizationArcus Biosciences, Inc.
- Primary IDPRISM-1
- Secondary IDsNCI-2024-08194, 2024-513317-12-00, jRCT2061240084
- ClinicalTrials.gov IDNCT06608927