Find Familial Adenomatous Polyposis Clinical Trials Near You
A Phase 3, Multi-Site, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of eRapa to Improve Clinical Outcomes in Patients With Familial Adenomatous Polyposis
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main goal of this clinical trial is to learn if the drug eRapa works to slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). Researchers will compare eRapa to Placebo. The questions to be answered by this trial are: * Does taking eRapa help to slow down the progression of the disease in patients with FAP? * Is eRapa a safe treatment for patients diagnosed with FAP? * What is the effect of eRapa on the number of polyps found in GI tract of patients diagnosed with FAP? * How does treatment with eRapa affect a patient's quality of life? Participants will: * Take eRapa or placebo once per day every other week until disease progresses (gets worse), stops taking part in the trial or dies. * Visit the clinic once every 3 months for check ups and tests. * Have an endoscopy at the start of the trial and then every 6 months to check on whether the disease is getting better or worse.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant must be ≥18 years of age inclusive.
• Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing.
• Participant must have at least 1 of the following high-risk features: \>100 polyps but ≤500 polyps in the colon, or ≥10 polyps in the retained rectum/sigmoid or ileal pouch (≥3 mm in size), or Spigelman stage 3 or 4 with at least 1 polyp ≥10 mm to be removed at baseline or on endoscopy performed within 18 months of screening.
• Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment.
• Agree not to donate gametes for the purpose of reproduction until at at least 12 weeks after stopping study treatment.
• Willing to undergo endoscopic evaluation.
Locations
United States
California
City of Hope
RECRUITING
Arcadia
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
Digestive & Liver Center of Florida
RECRUITING
Orlando
Cleveland Clinic Florida
RECRUITING
Weston
Illinois
University of Chicago
RECRUITING
Chicago
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Missouri
Department of Surgery, Section of Colon Rectal and Surgery