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Familial Adenomatous Polyposis

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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)

 

Study Description

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.

Subject Eligibility

Study Design

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.

Requirements

Over the 2-year study period, be willing to:

Primary Investigator: Elena Stoffel, MD, MPH

Co-investigator: D. Kim Turgeon, MD

Study Coordinator: Erika Koeppe, e-mail: eskoeppe@med.umich.edu phone: (734) 998-1274