Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
NCT05630794 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Colonoscopy
- PROCEDURE Biopsy Procedure
- OTHER Questionnaire Administration
- DRUG Dordaviprone Hydrochloride
Study Locations (5)
Ohio
- Cleveland Clinic Foundation — Cleveland
- Ohio State University Comprehensive Cancer Center — Columbus
Michigan
- University of Michigan Rogel Cancer Center — Ann Arbor
Missouri
- Washington University School of Medicine — St Louis
Rhode Island
- Rhode Island Hospital — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-10-06 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05630794
The ClinicalTrials.gov registry entry for NCT05630794 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Colorectal Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05630794 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Ohio, Michigan, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05630794 about?
NCT05630794 is a clinical study titled "Testing for Safety and Colorectal Cancer Preventive Effects of ONC201". 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 ...
What is the current status of trial NCT05630794?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-10-06. Estimated completion is 2028-03-01.
What conditions does trial NCT05630794 study?
This clinical trial studies the following conditions: Colorectal Carcinoma, Familial Adenomatous Polyposis, Colorectal Adenomatous Polyp, Multiple Adenomatous Polyps. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05630794?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Colonoscopy (PROCEDURE), Biopsy Procedure (PROCEDURE), Questionnaire Administration (OTHER), Dordaviprone Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05630794?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05630794 being conducted?
This trial has 5 study locations across Michigan, Missouri, Ohio, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.