RecruitingPhase 1NCT05630794

Testing for Safety and Colorectal Cancer Preventive Effects of ONC201

Phase I Trial of ONC201 for Chemoprevention of Colorectal Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

36 participants

Start Date

Oct 6, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called ONC201 can prevent colorectal polyps (pre-cancerous growths) from coming back or growing in people who are at high risk for colorectal cancer. This includes people with a hereditary condition called familial adenomatous polyposis (FAP) or those who have had many polyps found on a recent colonoscopy. **You may be eligible if...** - You are 18 or older at high risk for colorectal cancer (either due to FAP or a history of 5 or more small polyps, or 3 or more polyps with at least one large one) - You are due for a routine colonoscopy and have at least two polyps of 5 mm or larger that the doctor can mark and monitor - Your blood counts, liver, and kidney function are within acceptable ranges - Your expected survival is at least 5 years - You are willing to have a second follow-up endoscopy about 12 weeks after starting treatment **You may NOT be eligible if...** - You are pregnant or may become pregnant during the study (contraception is required) - You have had a prior unrelated invasive cancer in the past 5 years (minor exceptions apply) - Your overall health or organ function is significantly compromised Talk to your doctor to see if this trial is right for you.

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

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood

PROCEDUREColonoscopy

Undergo colonoscopy

DRUGDordaviprone Hydrochloride

Given PO

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESigmoidoscopy

Undergo sigmoidoscopy


Locations(5)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

View Full Details on ClinicalTrials.gov

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NCT05630794


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