Testing for Safety and Colorectal Cancer Preventive Effects of ONC201

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2028

Conditions
Colorectal Adenomatous PolypColorectal CarcinomaFamilial Adenomatous PolyposisMultiple Adenomatous Polyps
Interventions
PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Colonoscopy

Undergo colonoscopy

DRUG

Dordaviprone

Given PO

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Sigmoidoscopy

Undergo sigmoidoscopy

Trial Locations (5)

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

48109

RECRUITING

University of Michigan Comprehensive Cancer Center, Ann Arbor

63110

RECRUITING

Washington University School of Medicine, St Louis

02903

RECRUITING

Rhode Island Hospital, Providence

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT05630794 - Testing for Safety and Colorectal Cancer Preventive Effects of ONC201 | Biotech Hunter | Biotech Hunter