Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Phase I Trial of ONC201 for Chemoprevention of Colorectal Cancer
National Cancer Institute (NCI)
36 participants
Oct 6, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Undergo biopsy
Undergo collection of blood
Undergo colonoscopy
Given PO
Ancillary studies
Undergo sigmoidoscopy
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05630794