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Testing for Safety and Colorectal Cancer Preventive Effects of ONC201

Research Group
Gastrointestinal and Other Cancers
Sponsor
National Cancer Institute (NCI)
Status
Recruiting
NCT ID
NCT05630794
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.
Intervention
Biopsy Procedure, Biospecimen Collection, Colonoscopy, Dordaviprone, Questionnaire Administration, Sigmoidoscopy
Condition
Colorectal Adenomatous Polyp, Colorectal Carcinoma, Familial Adenomatous Polyposis, Multiple Adenomatous Polyps
Investigators
Alexander G Raufi, MD, Paul E. Wise, Peter P. Stanich, Elena M. Stoffel, Carol A. Burke, Alexander G. Raufi
CT Research Area
Prevention

See list of participating sites