Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Age 10-17 years

• Confirmed deleterious FAP genotype based on central genetic testing or personal history ot >2 colorectal adenomas and a parent with the diagnosis of FAP and either A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal history of colorectal adenomas and a first degree relative with FAP C: No genotype identified with a personal history of > 2 adenomas and have a parent with FAP

• Less than 30 polyps, which need to be removed to render the colon polyp-free before study drug can be given

Exclusion Criteria:

• Diagnosis of attenuated FAP based on central genetic testing in the absence of a personal history of >2 colorectal adenomas and a first degree relative (parent or sibling) with FAP.

• Sensitivity to COX-2 inhibitors