CPP-1X and SULINDAC in patients with FAP
Research type
Research Study
Full title
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)
IRAS ID
108958
Contact name
Jeffrey Jacob
Contact email
Sponsor organisation
Cancer Prevention Pharmaceuticals
Eudract number
2012-000427-41
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
VHP # 297 (VHP 201334), VHP application; REec# 2013-0545, Spanish Clinical Studies Registry
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
The FAP-310 trial is evaluating a drug combination (eflornithine (CPP-1X) plus sulindac) for patients with FAP (familial adenomatous polyposis). This study will determine if the combination drug treatment can work better than each drug alone in preventing the disease from getting worse. It will also look to see if this treatment for FAP can reduce the number and/or size of colon polyps and at how the medication might change quality of life.
Eflornithine (CPP-1X) is an experimental drug that has also been shown to reduce the growth of polyps in the colon. Sulindac is a drug similar to aspirin, naproxen, and ibuprofen in that it blocks inflammation. Sulindac has been shown in several studies to reduce the growth of colon polyps, but has not been approved for this indication.
Participants will receive at least 1 active drug. Participants will take 4 pills once a day for up to 2 years. Subjects will be followed by the study Investigator to see how they are responding to treatment. Subjects will be screened at one of the participating centres to see if they meet the eligibility requirements. Study evaluations include upper and lower endoscopies, physical exam and testing of blood and urine samples to check general health.Subjects may be eligible if they have FAP and are at least 18 years old; have not had their colon removed, but are considering surgery, OR have advanced disease in their upper intestine (duodenum), OR have had their colon removed and have advanced disease in your pouch/rectum and have a mutation in the APC gene. Subjects would not be eligible if they have diabetes requiring medication to control sugar levels, have high risk of heart disease or have hearing loss and wear a hearing aid, or are pregnant or nursing a baby.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/0100
Date of REC Opinion
15 May 2014
REC opinion
Further Information Favourable Opinion