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Testing for Safety and Colorectal Cancer Preventive Effects of ONC201

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later May 1, 2027 → Jul 1, 2028
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 78 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 1, 2027 to Jul 1, 2028 Completion pushed from Mar 1, 2028 to May 1, 2029 · Interventions modified · Eligibility criteria expanded, about 62 words · 1 more Show 4 more changesShow less
    • Completion pushed from Mar 1, 2028 to May 1, 2029
    • Interventions modified
    • Eligibility criteria expanded, about 62 words
    • Study description expanded, about 10 words
  2. Re-verified, no change to tracked fieldsv77
  3. Site details revised at 1 of 5 sitesv76
  4. 24 versions Re-verified since Mar 10, 2026, no change to tracked fieldsv52-v75
  5. Site details revised at 1 of 5 sitesv51
Show 22 earlier versionsHide 22 earlier versions
  1. Re-verified, no change to tracked fieldsv50
  2. Interventions: Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Colonoscopy (Procedure), Dordaviprone (Drug), Questionnaire… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Colonoscopy (Procedure), Dordaviprone Hydrochloride (Drug), Questionnaire… Site details revised at 1 of 5 sitesv49 Show 1 more changeShow less
    • Site details revised at 1 of 5 sites
  3. 5 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv44-v48
  4. Study Status, Contacts/Locationsv43
  5. 14 versions Re-verified since Jan 22, 2026, no change to tracked fieldsv29-v42
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05630794
Lead Sponsor National Cancer Institute (NCI)
Conditions Colorectal Adenomatous Polyp, Colorectal Carcinoma, Familial Adenomatous Polyposis, Multiple Adenomatous Polyps
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov