Clinical Trial: Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis

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

Detailed Summary: Per DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.
Sponsor: Pfizer

Current Primary Outcome: Time to Disease Progression [ Time Frame: 5 years ]

Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events:

  1. Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or
  2. Diagnosis of colorectal malignancy (ColMal).


Original Primary Outcome: To compare the time from randomization to treatment failure over a 5 year period in subjects treated with celecoxib vs placebo. [ Time Frame: 5 years ]

Current Secondary Outcome:

  • Time to Treatment Failure [ Time Frame: 5 years ]

    Time to treatment failure was defined as time from randomization to the earliest occurrence of one or more of the following:

    • Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps), or
    • Diagnosis of colorectal malignancy (ColMal), or
    • Treatment related dropout (DO). The treatment related dropout was defined as insufficient clinical response, progression of disease, death, adverse event, treatment-related laboratory abnormality, subject no longer willing to participate in study, and other reasons that might be related to treatment as determined by treating physicians in a blind fashion before database release.
  • Total Number of Colorectal Polyps [ Time Frame: Years 1 - 5 ]

    Total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5 cumulatively.

    Weighted total number of colorectal polyps over Years 1 - 5 cumulatively was defined as the total number of colorectal polyps >2 mm in size, that were detected over Years 1 - 5, divided by the number of colonoscopies that the participant had during the study.

  • Colorectal Polyp Burden [ Time Frame: Years 1 - 5 ]

    The polyp burden was defined as the sum of the largest diameters of all polyps (>2 mm in size) over Years 1 - 5 cumulatively.

    Weighted colorectal polyp burden over Years 1 - 5 cumulatively was defined as the polyp burden over Years 1 - 5 divided by the number of colonoscopies that the participant had during the study.



Original Secondary Outcome:

  • To compare in the intent-to-treat population the time from randomization to treatment failure for subjects treated with celecoxib versus subjects treated with placebo [ Time Frame: 5 years ]
  • To compare colorectal polyp burden over 5 years for subjects treated with celecoxib versus subjects treated with placebo. [ Time Frame: 5 years ]
  • To compare between subjects treated with celecoxib versus subjects treated with placebo the total number of colorectal polyps (>2 mm in size) detected over years<br>1-5 cumulatively. [ Time Frame: 5 years ]


Information By: Pfizer

Dates:
Date Received: January 1, 2008
Date Started: September 2006
Date Completion:
Last Updated: October 28, 2014
Last Verified: October 2014