ACTIVE_NOT_RECRUITING

Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

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Conditions

Metastatic Pancreatic Ductal AdenocarcinomaQuemliclustatCD73 InhibitorTreatment naivePancreatic cancerPRISM-1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-13
Study Completion:2030-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06608927

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have histologically or cytologically confirmed PDAC that is metastatic.
  2. * Have not been previously treated for PDAC in the metastatic setting.
  3. 1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
  4. 2. 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.
  5. 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.
  6. * Eastern Cooperative Oncology Group PS of 0 to 1.
  7. * 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.
  1. * Previously treated for locally advanced, unresectable PDAC.
  2. * History of brain metastases or leptomeningeal metastases.
  3. * Prior treatment with a CD73 antagonist or inhibitor.
  4. * Underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Arcus Biosciences

Study Locations (Sites)

Mayo Clinic Arizona - Phoenix Campus
Phoenix, Arizona, 85054
United States
University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of California San Diego Health
La Jolla, California, 92093
United States
Cancer & Blood Specialty Clinic - Los Alamitos
Los Alamitos, California, 90720
United States
Keck Medicine of USC - Keck Hospital of USC
Los Angeles, California, 90033-5315
United States
Sutter Medical Center
Roseville, California, 95661
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, 90404
United States
USOR - Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, 80218
United States
Yale Cancer Center
New Haven, Connecticut, 06520
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224-1865
United States
Miami Cancer Institute
Miami, Florida, 33176
United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
USOR - Illinois Cancer Specialists - Arlington Heights
Arlington Heights, Illinois, 60005
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
United States
Cancer Center of Kansas - Medical Arts Tower
Wichita, Kansas, 67208
United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809
United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
United States
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
Grand Rapids, Michigan, 49503
United States
HealthPartners Cancer Research Center - Cancer Center at Regions Hospital
Minneapolis, Minnesota, 55404
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
MediSync Clinical Research - Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68105
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903-2681
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
New York University Medical Oncology Associates
New York, New York, 10016
United States
Columbia University Irving Medical Center - Herbert Irving Pavilion
New York, New York, 10032
United States
Memorial Sloan-Kettering Cancer Center - New York - Rockefeller Outpatient Pavilion
New York, New York, 10065
United States
Mount Sinai Medical Center Comprehensive Cancer Center
New York, New York, 10128
United States
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
USOR - Texas Oncology - Austin Midtown
Austin, Texas, 78705
United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
USOR - Texas Oncology - San Antonio Medical Center
San Antonio, Texas, 78240
United States
USOR - Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, 77598
United States
Inova Medical Group - Hematology Oncology - Arlington
Fairfax, Virginia, 22031
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Summit Cancer Centers - Spokane Valley
Spokane, Washington, 99208
United States
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
Vancouver, Washington, 98684
United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Arcus Biosciences, Inc.

  • Medical Director, STUDY_DIRECTOR, Arcus Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-13
Study Completion Date2030-11-30

Study Record Updates

Study Start Date2024-12-13
Study Completion Date2030-11-30

Terms related to this study

Keywords Provided by Researchers

  • Quemliclustat
  • CD73 Inhibitor
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Treatment naive
  • Pancreatic cancer
  • PRISM-1

Additional Relevant MeSH Terms

  • Metastatic Pancreatic Ductal Adenocarcinoma