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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00585312
First received: January 1, 2008
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Adenomatous Polyposis Coli
Drug: Celecoxib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to Disease Progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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).


Secondary Outcome Measures:
  • Time to Treatment Failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 106
Study Start Date: September 2006
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib
celecoxib, 16 mg/kg/day, for 5 years
Drug: Celecoxib
celecoxib, 16 mg/kg/day, for 5 years
Other Name: celebrex, SC-58635
Placebo Comparator: Placebo
Masked, placebo comparator
Drug: Placebo
Masked, placebo comparator

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585312

  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00585312     History of Changes
Obsolete Identifiers: NCT00393016, NCT00534040
Other Study ID Numbers: A3191193
Study First Received: January 1, 2008
Results First Received: October 28, 2014
Last Updated: October 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
FAP

Additional relevant MeSH terms:
Adenomatous Polyposis Coli
Adenoma
Adenomatous Polyps
Colonic Diseases
Colonic Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyposis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Syndromes, Hereditary
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 07, 2015