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NCT05630794 · ClinicalTrials.gov registry record · Phase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
A Phase 1 study of Colorectal Carcinoma and Familial Adenomatous Polyposis, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 5
- Study locations
NCT05630794: Recruiting Phase 1 study of Colorectal Carcinoma and Familial Adenomatous Polyposis, sponsored by National Cancer Institute (NCI).
NCT05630794 is a Phase 1 study of Colorectal Carcinoma and Familial Adenomatous Polyposis that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 1,096-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630794, a Phase 1 study of Colorectal Carcinoma and Familial Adenomatous Polyposis, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
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 |
What NCT05630794 shows while recruiting
NCT05630794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,096-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (97% lower).
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.
NCT05630794 lists 5 locations in 4 states (Ohio, Michigan, Missouri).
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.
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).
Who is sponsoring clinical trial NCT05630794?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05630794's enrollment target sits among peer trials
36 45th of 53 higher than 9 of 53 other Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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