ONC201 for Colorectal Cancer Prevention

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial tests the safety, side effects, and best dose of Akt/ERK Inhibitor ONC201 (ONC201) in preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) or a history of multiple polyps. ONC201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Alexander G Raufi

Principal Investigator

Rhode Island Hospital

Eligibility Criteria

This trial is for adults at high risk of colorectal adenomas, specifically those with familial adenomatous polyposis (FAP) or a history of multiple polyps. Participants must be in good health with an ECOG performance status <=1 and have normal organ function. They should not have had invasive cancer treatments within the last 3 years, except for certain skin cancers or cervical cancer in situ.

Inclusion Criteria

I am willing and able to follow the study's schedule and procedures.

I am at high risk for colorectal adenomas due to FAP or having more than 5 small adenomas or at least 3 with one being larger than 10mm.

I am 18 years old or older.

Exclusion Criteria

I have a history of Lynch syndrome.

I am not pregnant or nursing, as the treatment may harm the baby.

I am not currently on any experimental drugs and haven't been for the last 4 weeks.

Treatment Details

Interventions

• ONC201 (Akt/ERK Inhibitor)

Trial Overview The trial is testing ONC201's safety and optimal dosage to prevent colorectal cancer in patients prone to developing polyps. It involves procedures like colonoscopy, biopsy collection, and questionnaires to monitor effects on tumor cell growth inhibition by targeting specific enzymes.

Participant Groups

Group I: Prevention (ONC201, biopsy, sigmoidoscopy, colonoscopy) Experimental Treatment 6 Interventions

Patients receive ONC201 PO QW or Q3W for 12 weeks. Patients also undergo collection of blood, tissue biopsy, and sigmoidoscopy/colonoscopy throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+