Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Public ClinicalTrials.gov record NCT05630794. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I Trial of ONC201 for Chemoprevention of Colorectal Cancer
Study identification
- NCT ID
- NCT05630794
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Colonoscopy Procedure
- Dordaviprone Hydrochloride Drug
- Questionnaire Administration Other
- Sigmoidoscopy Procedure
Procedure · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 5, 2025
- Primary completion
- Apr 30, 2027
- Completion
- Feb 29, 2028
- Last update posted
- May 12, 2026
2025 – 2028
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05630794, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 12, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05630794 live on ClinicalTrials.gov.