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Bile Acid Analog
Obeticholic Acid for Familial Adenomatous Polyposis
Phase 2
Recruiting
Led By Eduardo Vilar-Sanchez
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
Participants must have no evidence of active or recurrent invasive cancer for 6 months prior to screening
Presence of Spigelman stage II or III duodenal polyposis at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
Study Summary
This trial is investigating if a drug similar to a bile acid can help prevent the development of cancer in patients with a gene defect that increases their risk.
Who is the study for?
Adults with familial adenomatous polyposis (FAP), a condition causing many polyps in the intestine, can join this trial. They must have an APC gene mutation or clinical diagnosis of FAP, be in good general health (ECOG <=1), and not have had cancer treatment for at least 6 months. Participants need functioning major organs as indicated by specific blood tests and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing Obeticholic Acid (OCA) to see if it's safe and effective at reducing intestinal polyps in FAP patients. OCA mimics a bile acid made by the liver that may help prevent cancer growth. Patients will either receive OCA or a placebo while undergoing endoscopies, biopsies, and questionnaires to monitor effects.See study design
What are the potential side effects?
Possible side effects of OCA include itching, fatigue, abdominal pain, rash, digestive issues like constipation or diarrhea, joint pain and swelling. There might also be more serious risks such as liver problems which would be closely monitored during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had signs of cancer coming back for at least 6 months.
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My duodenal polyps are classified as stage II or III.
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I have FAP affecting my duodenum and rectum, confirmed by genetic or clinical diagnosis.
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I am fully active or can carry out light work.
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My liver function tests are normal.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage change in duodenal polyp burden
Secondary outcome measures
Absolute differences in the levels of serum FGF19 and C4
Changes in gene expression (messenger ribonucleic acid) profiles of adenomas and normal mucosa
Changes in the microbiome of adenomas and normal mucosa
+5 moreSide effects data
From 2022 Phase 2 trial • 10 Patients • NCT0243007740%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo for Obeticholic Acid
Active Capsule of Obeticholic Acid
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (OCA)Experimental Treatment5 Interventions
Patients receive OCA PO QD for 6 months in the absence of unacceptable toxicity. Patients also undergo GI endoscopy with biopsy and collection of blood samples at screening and on study.
Group II: Arm II (placebo)Placebo Group5 Interventions
Patients receive placebo PO QD for 6 months in the absence of unacceptable toxicity. Patients also undergo GI endoscopy with biopsy and collection of blood samples at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obeticholic Acid
2015
Completed Phase 2
~130
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,925 Total Patients Enrolled
Eduardo Vilar-SanchezPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cholesterol levels are very high and not under control.I haven't had signs of cancer coming back for at least 6 months.I am not taking any medications that are not allowed in this trial.My duodenal polyps are classified as stage II or III.I have FAP affecting my duodenum and rectum, confirmed by genetic or clinical diagnosis.I do not have any uncontrolled illnesses.I am not willing to stop taking certain medications for the study.I am fully active or can carry out light work.I have had pancreatitis or issues with my pancreas.I have an active hepatitis C or B infection that hasn't been treated.I have a liver condition such as cirrhosis, NASH, or a biliary disorder.My liver function tests are normal.I have previously used the drug being studied.I am 18 years old or older.My biopsy shows high-grade dysplasia or cancer.I have too many polyps in my duodenum or rectum to count.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (placebo)
- Group 2: Arm I (OCA)
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential adverse effects are associated with the ingestion of Obeticholic Acid?
"Our team at Power has assessed the safety of Obeticholic Acid as a 2 due to it being in Phase 2, where there is some evidence of security but not efficacy."
Answered by AI
Are there any available openings for participants in this experiment?
"Affirmative. Per the information accessible through clinicaltrials.gov, this medical research is actively recruiting subjects since its inception on September 19th 2022 and subsequent updates to the page on September 27th 2022. A total of 60 patients are needed for participation across 5 distinct sites."
Answered by AI
Are there any participating healthcare facilities administering this research in the North American region?
"Patients can enroll in this clinical trial at the Dana-Farber Cancer Institute located in Boston, Massachusetts, Cleveland Clinic Foundation situated in Ohio, and M D Anderson Cancer Center based out of Houston Texas. Additionally, there are 5 other sites offering recruitment services for this study."
Answered by AI
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