Testing for Safety and Colorectal Cancer Preventive Effects of ONC201

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05630794
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Colorectal Adenomatous Polyp
  • Colorectal Carcinoma
  • Familial Adenomatous Polyposis
  • Multiple Adenomatous Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Colonoscopy — PROCEDURE
    Undergo colonoscopy
  • Dordaviprone Hydrochloride — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Sigmoidoscopy — PROCEDURE
    Undergo sigmoidoscopy

Study Details

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.

Key Dates

Start date
Oct 6, 2025
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prevention (ONC201, biopsy, sigmoidoscopy, colonoscopy)
    Patients receive ONC201 PO QW or Q3W for 13 weeks. Patients also undergo collection of blood, tissue biopsy, and sigmoidoscopy/colonoscopy throughout the study.

Primary Outcome Measure

Proportion of participants with unacceptable toxicity [ Time Frame: Up to 35 days post last dose of ONC201 ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Elena M. Stoffel
[email protected]
734-936-0781
Elena M. Stoffel (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Paul E. Wise
[email protected]
314-454-7177
Paul E. Wise (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Carol A. Burke
[email protected]
216-444-6864
Carol A. Burke (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Peter P. Stanich
[email protected]
614-293-6255
Peter P. Stanich (PRINCIPAL_INVESTIGATOR)
Rhode Island HospitalProvidenceRhode Island02903
Alexander G. Raufi
[email protected]
401-787-0988
Alexander G. Raufi (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MIWashington University School of Medicine· St Louis, MOCleveland Clinic Foundation· Cleveland, OHOhio State University Comprehensive Cancer Center· Columbus, OHRhode Island Hospital· Providence, RI

Related Studies