Spots Global Cancer Trial Database for A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
Official Title: Precision Promise Platform Trial for Metastatic Pancreatic Cancer
Study ID: NCT04229004
Study Description
Brief Summary: Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. Primary Objectives * To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm. Secondary Objectives * To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC. * To determine progression-free survival (PFS) for each investigational arm vs. SOC. * To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first). * To determine rates of clinical benefit; duration of clinical benefit.
Detailed Description: Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer. The goal of the platform is to find effective therapies for pancreatic cancer. The platform will test multiple investigational drugs and combinations compared to standard of care therapy in first and second line metastatic participants. Bayesian response-adaptive randomization will be used to assign participants to arms based on their performance in subtypes of the disease. The primary endpoint is overall survival.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of Florida College of Medicine, Gainesville, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan - Rogel Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center (MCCC), Rochester, Minnesota, United States
Siteman Cancer Center - Washington University Medical Campus, Saint Louis, Missouri, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
New York University Langone Medical Center - Perlmutter Cancer Center, New York, New York, United States
Evelyn H. Lauder Breast Center - Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Physicians - Solid Tumor/Gastrointestinal Oncology, New York, New York, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
University of Pennsylvania - Abramson Cancer Center, Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Commonwealth University School of Medicine, Richmond, Virginia, United States
Virginia Mason Hospital & Seattle Medical Center, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
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