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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 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.
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.
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 |
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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, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,096-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (97% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.
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