OncoMatch/Clinical Trials/NCT05630794
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Is NCT05630794 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Dordaviprone Hydrochloride for colorectal adenomatous polyp.
Treatment: Dordaviprone Hydrochloride — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Prior history of exposure to cytotoxic chemotherapy or ONC201
Cannot have received: (ONC201)
Prior history of exposure to cytotoxic chemotherapy or ONC201
Cannot have received: investigational agent
Participants may not be currently receiving any other investigational agents or have received any investigational agents within the past four weeks
Lab requirements
Blood counts
Leukocytes >= 3,000/microliter; Absolute neutrophil count >= 1,000/microliter; Platelets >= 100,000/microliter
Kidney function
Creatinine <= 1.5 x institutional upper limit of normal
Liver function
Total bilirubin within normal institutional limits; AST/ALT <= 1.5 x institutional upper limit of normal
Cardiac function
QTc interval > 480 ms (excluded); history of Torsades de pointes, heart failure, or family history of prolonged QT Syndrome (excluded)
Leukocytes >= 3,000/microliter; Absolute neutrophil count >= 1,000/microliter; Platelets >= 100,000/microliter; Total bilirubin within normal institutional limits; AST/ALT <= 1.5 x institutional upper limit of normal; Creatinine <= 1.5 x institutional upper limit of normal; QTc interval > 480 milliseconds (excluded); history of Torsades de pointes, heart failure, or family history of prolonged QT Syndrome (excluded)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Rogel Cancer Center · Ann Arbor, Michigan
- Washington University School of Medicine · St Louis, Missouri
- Cleveland Clinic Foundation · Cleveland, Ohio
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
- Rhode Island Hospital · Providence, Rhode Island
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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