Clinical Trial: Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase III Trial of the Safety and Efficacy of Eflornithine Combined With Sulindac Compared to Eflornithine, Sulindac as Single Agents in Patients With Familial Adenomatous Polypo

Brief 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.

Detailed Summary:
Sponsor: Cancer Prevention Pharmaceuticals, Inc.

Current Primary Outcome: Delaying time to the 1st occurrence of any FAP-related event. [ Time Frame: 24 months from the start of treatment ]

Original Primary Outcome: Delaying time to the 1st occurrence of any FAP-related event. FAP-related events include excisional intervention involving the colon, rectum, pouch, duodenum and/or clinically important events of progression of duodenal polyposis, cancer or death. [ Time Frame: 24 months from the start of treatment ]

Current Secondary Outcome:

  • presence or absence of an ODC polymorphism [ Time Frame: 24 months from the start of treatment ]
    evaluate the potentially effect modifying properties of an ornithine decarboyxlase (ODC) polymorphism on primary outcome
  • excretion of 4 urinary polyamines [ Time Frame: 24 months from the start of treatment ]
    evaluate the potentially effect modifying properties of 4 urinary polyamines


Original Secondary Outcome:

  • Incidence of adverse events and clinical laboratory abnormalities. [ Time Frame: 24 months from the start of treatment ]
  • Time to the 1st FAP-related beneficent event; regression of rectal/pouch polyposis; regression of duodenal polyposis [ Time Frame: 24 months from the start of treatment ]
  • Pharmacokinetics of eflornithine and sulindac [ Time Frame: 24 months from the start of treatment ]


Information By: Cancer Prevention Pharmaceuticals, Inc.

Dates:
Date Received: November 21, 2011
Date Started: October 2013
Date Completion: June 2018
Last Updated: April 11, 2016
Last Verified: April 2016