Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this randomized, double-blind, Phase III trial is to determine if the
combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single
agents in delaying time to the first occurrence of any FAP-related event. This includes: 1)
FAP related disease progression indicating the need for excisional intervention involving the
colon, rectum, pouch, duodenum and/or 2) clinically important events which includes
progression to more advanced duodenal polyposis, cancer or death.