Clinical Trial: A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Randomized Phase III Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP)
Brief Summary: The purpose of this phase III study is to evaluate the safety and efficacy of the combination of eflornithine and sulindac compared to single agent sulindac or eflornithine in reducing the number of polyps in patients with familial adenomatous polyposis (FAP).
Detailed Summary:
Sponsor: Cancer Prevention Pharmaceuticals, Inc.
Current Primary Outcome: Efficacy of Eflornithine plus Sulindac compared to Eflornithine alone and Sulindac alone determined by change in the number of polyps 2 mm or greater in a defined focal area of the rectum or pouch at baseline and after completion of the study treatment. [ Time Frame: 6 months from the start of treatment. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in number of polyps 2 mm or greater in the distal 10 cm of rectum or pouch. [ Time Frame: 6 months from the start of treatment. ]
- Qualitative change in overall colon/rectum/pouch polyp burden (number and size). [ Time Frame: 6 months from the start of treatment. ]
- Presence of high grade dysplasia or villous adenoma in any polyp resected. [ Time Frame: 6 months from the start of treatment. ]
Original Secondary Outcome: Same as current
Information By: Cancer Prevention Pharmaceuticals, Inc.
Dates:
Date Received: November 19, 2010
Date Started: March 2011
Date Completion: June 2013
Last Updated: April 23, 2015
Last Verified: April 2015
