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Study identifier: NCT05630794 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Testing for Safety and Colorectal Cancer Preventive Effects of ONC201

Condition: Colorectal Adenomatous Polyp · Colorectal Carcinoma · Familial Adenomatous Polyposis  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants36
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The purpose of this phase I trial is to test the safety and cancer preventive effects of different doses of ONC201 in people with familial adenomatous polyposis (FAP) or a history of multiple polyps. People with familial adenomatous polyposis (FAP) or a history of multiple polyps are at higher than average risk of developing colorectal cancer. ONC201, now known as dordaviprone, is a drug that may stop cancer cells from growing. This drug has been shown in previous studies to cause cancer cell death but not harm normal cells. If successful, this study may help us develop a new option for colorectal cancer prevention.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (5)

University of Michigan Rogel Cancer CenterAnn Arbor, Michigan, United StatesRecruiting
Washington University School of MedicineSt Louis, Missouri, United StatesNot Yet Recruiting
Cleveland Clinic FoundationCleveland, Ohio, United StatesRecruiting
Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesRecruiting
Rhode Island HospitalProvidence, Rhode Island, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT05630794