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)
Brief Description Of Study
This study intends to compare the effectiveness, safety and pharmacokinetics (meaning the "behavior" of the medicine once it is inside of your body) of the medicines CPP-1X (a drug in Phase III trials) combined with sulindac (a drug already approved by the FDA), versus CPP-1X and sulindac medications alone. The medications will be evaluated over a 24 month treatment period in patients with Familial Adenomatous Polyposis (FAP). The study is randomized, and double-blind. We are treating patients diagnosed with FAP, who are also positive for the APC mutation (meaning certain genes were "deleted" and/or "changed", making them act differently than how they are supposed to in the body), and are over the age of 18.