Clinical trialNCT05630794RecruitingPhase 1Interventional

Testing for Safety and Colorectal Cancer Preventive Effects of ONC201

SponsorNational Cancer Institute (NCI)Enrollment36Colorectal Adenomatous PolypColorectal CarcinomaFamilial Adenomatous PolyposisMultiple Adenomatous Polyps

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Alexander G Raufi, MD
Brown University Health/ Rhode Island Hospital
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Elena M. Stoffel
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Paul E. Wise
Not, yet, recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Carol A. Burke
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Peter P. Stanich
Recruiting
Rhode Island Hospital
Providence, Rhode Island, United States
Alexander G. Raufi
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Dordaviprone

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 6 Oct 2025
Primary completion: 1 May 2027
Completion: 1 Mar 2028
Last update posted: 12 Jun 2026
Registered enrollment: 36
Registry id: NCT05630794

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.