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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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 days post last dose of onc201
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 35 days post last dose of onc201
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 days post last dose of onc201
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in human adenoma tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) expression in polyps induced by ONC201
Secondary study objectives
Mean change in normal human mucosa TRAIL expression induced by ONC201
Proportion and severity of treatment emergent adverse events
Other study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Colonoscopy
2012
Completed Phase 3
~115560
Sigmoidoscopy
2007
Completed Phase 2
~140
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,012,008 Total Patients Enrolled
Alexander G RaufiPrincipal InvestigatorRhode Island Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have a history of Lynch syndrome.I am 18 years old or older.I am not pregnant or nursing, as the treatment may harm the baby.I am mostly active and can carry out light work.I am willing to have a second endoscopy for research after starting ONC201.I am not currently on any experimental drugs and haven't been for the last 4 weeks.I have had colorectal cancer before.I have been treated with chemotherapy or ONC201 before.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am scheduled for a colonoscopy and have at least two adenomas larger than 5mm.I agree to use birth control or abstain from sex during and 4 weeks after the study.I haven't had any cancer that is getting worse or needs treatment in the last 3 years, except for certain skin cancers or cervical cancer.I will have 6 biopsies taken from healthy colon tissue near a polyp.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (ONC201, biopsy, sigmoidoscopy, colonoscopy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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