Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Diagnoza rodzinnej polipozy jelita grubego (FAP) lub więcej niż 5 małych polipów (poniżej 1 cm) albo co najmniej 3 polipy z czego jeden co najmniej 1 cm, stwierdzone w ostatnich 5 latach
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia pozwalający na udział w badaniu
- •Prawidłowe wyniki badań krwi (liczba białych krwinek, płytek krwi) i funkcja nerek i wątroby
- •Oczekiwanie standardowego badania jelita grubego z usunięciem polipów
- •Co najmniej 2 polipy o wielkości minimum 5 mm podczas zaplanowanego badania
- •Zgoda na drugie badanie jelita grubego około 12 tygodni po rozpoczęciu leczenia
- •Stosowanie antykoncepcji (dla kobiet i mężczyzn w wieku rozrodczym)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 15, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (5)
University of Michigan Rogel Cancer Center
Ann Arbor, United States
Washington University School of Medicine
St Louis, United States
Cleveland Clinic Foundation
Cleveland, United States
Ohio State University Comprehensive Cancer Center
Columbus, United States
Rhode Island Hospital
Providence, United States
Trial contact
Elena M. Stoffel
Elena M. Stoffel
PRINCIPAL_INVESTIGATOR
Paul E. Wise
Paul E. Wise
PRINCIPAL_INVESTIGATOR
Carol A. Burke
Carol A. Burke
PRINCIPAL_INVESTIGATOR
Peter P. Stanich
Peter P. Stanich
PRINCIPAL_INVESTIGATOR
Alexander G. Raufi
Alexander G. Raufi
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/12/2026.
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