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ONC201 for Colorectal Cancer Prevention
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Prevention (ONC201, biopsy, sigmoidoscopy, colonoscopy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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