Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) (CHIP)

• ClinicalTrials.gov Identifier: NCT00585312
• Recruitment Status: Terminated
• First Posted: January 3, 2008
• Results First Posted: November 2, 2014
• Last Update Posted: February 21, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: January 1, 2008
• First Posted Date: January 3, 2008
• Results First Submitted Date: October 28, 2014
• Results First Posted Date: November 2, 2014
• Last Update Posted Date: February 21, 2021
• Study Start Date: September 2006
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 28, 2014)

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 Measures (submitted: January 1, 2008): 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 Measures (submitted: October 28, 2014)

• 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 Measures (submitted: January 1, 2008)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
• 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 Description: 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Adenomatous Polyposis Coli

Intervention

• Drug: Celecoxib
  celecoxib, 16 mg/kg/day, for 5 years
  Other Name: celebrex, SC-58635
• Drug: Placebo
  Masked, placebo comparator

Study Arms

• Experimental: Celecoxib
  celecoxib, 16 mg/kg/day, for 5 years
  Intervention: Drug: Celecoxib
• Placebo Comparator: Placebo
  Masked, placebo comparator
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 3, 2014): 106
• Original Estimated Enrollment (submitted: January 1, 2008): 200
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Czechia, Hong Kong, Hungary, Israel, Italy, Puerto Rico, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
• Removed Location Countries: Chile, Czech Republic

Administrative Information

• NCT Number: NCT00585312
• Other Study ID Numbers: A3191193
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2021