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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04229004
Study type Interventional
Source Pancreatic Cancer Action Network
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 31, 2020
Completion date June 24, 2027

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