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

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
  • Czechia
      • Praha, Czechia, 150 06
        • Pfizer Investigational Site
      • Praha 5, Czechia, 150 06
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong, 150001
        • Pfizer Investigational Site
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Pfizer Investigational Site
  • Hungary
      • Miskolc, Hungary, 3501
        • Pfizer Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • Pfizer Investigational Site
      • M.P. Lower Galilee, Israel, 15208
        • Pfizer Investigational Site
      • Petach Tikvah 49202, Israel
        • Pfizer Investigational Site
      • Tel Aviv, Israel, 64239
        • Pfizer Investigational Site
  • Italy
      • Roma, Italy, 00144
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 40
        • Pfizer Investigational Site
  • South Africa
    • Western Cape, South Africa
      • Cape Town, Western Cape, South Africa, South Africa, 7925
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
  • Sweden
      • Stockholm, Sweden, 17176
        • Pfizer Investigational Site
  • Ukraine
      • Donetsk, Ukraine, 83052
        • Pfizer Investigational Site
  • United Kingdom
    • England
      • Harrow, Middlesex, England, United Kingdom, HA1 3UJ
        • Pfizer Investigational Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10065
        • Pfizer Investigational Site
      • New York, New York, United States, 10022
        • Pfizer Investigational Site
      • New York, New York, United States, 10017
        • Pfizer Investigational Site
    • Ohio
      • Chagrin Falls, Ohio, United States, 44136
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45229
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Elyria, Ohio, United States, 44035
        • Pfizer Investigational Site
      • Independence, Ohio, United States, 44131
        • Pfizer Investigational Site
      • Lakewood, Ohio, United States, 44107
        • Pfizer Investigational Site
      • Lorain, Ohio, United States, 44053
        • Pfizer Investigational Site
      • Solon, Ohio, United States, 44138
        • Pfizer Investigational Site
      • Strongsville, Ohio, United States, 44136
        • Pfizer Investigational Site
      • Westlake, Ohio, United States, 44145
        • Pfizer Investigational Site
      • Willoughby Hills, Ohio, United States, 44094
        • Pfizer Investigational Site
      • Wooster, Ohio, United States, 44691
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030-4990
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84112
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Celecoxib
celecoxib, 16 mg/kg/day, for 5 years
Drug: Celecoxib
celecoxib, 16 mg/kg/day, for 5 years
Other Names:
  • celebrex, SC-58635
Placebo Comparator: Placebo
Masked, placebo comparator
Drug: Placebo
Masked, placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
Years 1 - 5
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.
Years 1 - 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

January 1, 2008

First Submitted That Met QC Criteria

January 1, 2008

First Posted (Estimate)

January 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3191193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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