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Akt/ERK Inhibitor

ONC201 for Colorectal Cancer Prevention

Phase 1
Waitlist Available
Led By Alexander G Raufi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be identified as high risk for recurrent colorectal adenomas, as defined by: A diagnosis of FAP AND/OR Findings of either > 5 small (less than 1 cm) adenomas OR >= 3 with at least one >= 10 mm on most recent endoscopy performed in the past 5 years
Be >= 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 days post last dose of onc201
Awards & highlights

Study Summary

This trial tests a drug to stop the growth of colorectal cancer in patients with a high risk for it. It blocks enzymes to stop tumor growth.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of ONC201 may include risks associated with enzyme inhibition that could affect cell growth. Specific side effects are not listed but could relate to typical reactions from similar medications such as digestive issues, fatigue, blood disorders, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I am 18 years old or older.
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I am mostly active and can carry out light work.
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I am scheduled for a colonoscopy and have at least two adenomas larger than 5mm.
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I agree to use birth control or abstain from sex during and 4 weeks after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 days post last dose of onc201
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 days post last dose of onc201 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in human adenoma tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) expression in polyps induced by ONC201
Secondary outcome measures
Mean change in normal human mucosa TRAIL expression induced by ONC201
Proportion and severity of treatment emergent adverse events
Other outcome measures
Adenoma-derived organoid take rates between samples obtained prior to and following treatment
Changes in Ki67, BCL2, Caspase 3, LGR5, CD44, CD133, and ALDH staining and NK cell infiltration in adenomas and in normal colonic mucosa obtained from participants prior to and following treatment with escalating doses of ONC201
Changes in mean cytokine/immune response levels (with attention to IL-10, IL-17A, TNFalpha, IL-6, granzyme A, and perforin) in sera, normal colonic mucosa, and adenomas between pre-, on-, and post-ONC201 treatment samples
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (ONC201, biopsy, sigmoidoscopy, colonoscopy)Experimental Treatment6 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sigmoidoscopy
2007
Completed Phase 2
~140
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1920
Colonoscopy
2012
Completed Phase 3
~115560

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,622 Total Patients Enrolled
Alexander G RaufiPrincipal InvestigatorRhode Island Hospital

Media Library

ONC201 (Akt/ERK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05630794 — Phase 1
Colorectal Cancer Research Study Groups: Prevention (ONC201, biopsy, sigmoidoscopy, colonoscopy)
Colorectal Cancer Clinical Trial 2023: ONC201 Highlights & Side Effects. Trial Name: NCT05630794 — Phase 1
ONC201 (Akt/ERK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630794 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a variety of sites conducting this research venture in the city?

"Enrolment is available at University of Michigan Comprehensive Cancer Center in Ann Arbor, Ohio State University Comprehensive Cancer Center in Columbus, and Washington Univeristy School of Medicine in Saint Louis. Additionally, there are 5 other participating sites."

Answered by AI

Is the research team still welcoming participants to join this experiment?

"This experiment is no longer searching for participants; the clinical trial was first posted 13th May 2023 and has not been updated since 29th November 2022. Nevertheless, there are numerous other trials currently seeking enrolment with 1,115 active studies at present."

Answered by AI

Has the FDA sanctioned Prevention (ONC201, biopsy, sigmoidoscopy, colonoscopy) yet?

"Due to the limited amount of data available for ONC201, biopsy, sigmoidoscopy and colonoscopy in Phase 1 trials, our team at Power assigned them a safety rating of 1."

Answered by AI
~16 spots leftby Jan 2026