Major Program
Cancer Prevention Clinical Trials Network
Research Group
Gastrointestinal and Other Cancers
Sponsor
National Cancer Institute (NCI)
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05223036
This phase IIa trial investigates if giving obeticholic acid (OCA) is safe and has a
beneficial effect on the number of polyps in the small bowel and colon in patients with
familial adenomatous polyposis (FAP). FAP is a rare gene defect that increases the risk of
developing cancer of the intestines and colon. OCA is a drug similar to a bile acid the body
makes. It is fluid made and released by the liver. OCA binds to a receptor in the intestine
that is believed to have a positive effect on preventing cancer development. OCA has been
effective in treating primary biliary cholangitis (PBC), a liver disease, and is approved by
the Food and Drug Administration (FDA) for use at a lower dose (10 mg). There have been
studies showing that OCA decreases inflammation and fibrosis. However, it is not yet known
whether OCA works on reducing the number of polyps in patients with FAP.
beneficial effect on the number of polyps in the small bowel and colon in patients with
familial adenomatous polyposis (FAP). FAP is a rare gene defect that increases the risk of
developing cancer of the intestines and colon. OCA is a drug similar to a bile acid the body
makes. It is fluid made and released by the liver. OCA binds to a receptor in the intestine
that is believed to have a positive effect on preventing cancer development. OCA has been
effective in treating primary biliary cholangitis (PBC), a liver disease, and is approved by
the Food and Drug Administration (FDA) for use at a lower dose (10 mg). There have been
studies showing that OCA decreases inflammation and fibrosis. However, it is not yet known
whether OCA works on reducing the number of polyps in patients with FAP.
Intervention
Biopsy, Obeticholic Acid, Placebo Administration, Biospecimen Collection, Gastrointestinal Endoscopy, Questionnaire Administration
Condition
Attenuated Familial Adenomatous Polyposis, Colorectal Carcinoma, Duodenal Carcinoma, Familial Adenomatous Polyposis
Investigators
Eduardo Vilar-Sanchez, Niloy J. Samadder, Ramona M. Lim, Elena M. Stoffel, Carol A. Burke, Marcia R. Cruz-Correa