Familial Adenomatous Polyposis
A double-blind, randomized, phase III trial of the safety and efficacy of CPP-1X/sulindac compared with CPP-1X/sulindac as single agents in patients with familial adenomatous polyposis (FAP)
Enrollment status: Closed for enrollment, follow-up continuing
Familial adenomatous polyposis (FAP) is a rare inherited disorder characterized by the development of multiple polyps in the colon that may eventually lead to cancer. In patients with this condition, hundreds to thousands of polyps can form in the large intestine.
This study is being conducted to determine whether taking a study drug can reduce the growth and/or progression of polyps in patients with FAP. Specifically, the study will test whether the combination of sulindac and CPP-1X (eflornithine, DFMO) is safe and more effective at reducing polyp burden than either drug by itself.
Subjects (male and female), age 18 years and older
Diagnosis of FAP
Intact colon OR if post-colectomy, have polyps in the duodenum and/or colon/rectum pouch
Approximately 150 eligible subjects with FAP from multiple international centers will be randomized in a 1:1:1 ratio to receive either CPP-1X plus sulindac, CPP-1X plus a placebo, or sulindac plus a placebo for up to 2 years.
Over the 2-year study period, be willing to:
Take a study drug once a day
Return to University of Michigan every 3 to 6 months for follow-up visits
Undergo biannual colonoscopy/upper endoscopy
Primary Investigator: Elena Stoffel, MD, MPH
Co-investigator: D. Kim Turgeon, MD
Study Coordinator: Erika Koeppe, e-mail: firstname.lastname@example.org phone: (734) 998-1274