Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Adenomatous Polyposis Coli Clinical Trial

— CHIP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00585312
• Other study ID #: A3191193
• Status: Terminated
• Phase: Phase 3
• Start date: September 2006
• Est. completion date: October 2013

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00393016
• NCT00534040

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Colorectal Neoplasms
• Nasopharyngeal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Gent
Czechia	Pfizer Investigational Site	Praha
Czechia	Pfizer Investigational Site	Praha 5
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	Shatin	New Territories
Hungary	Pfizer Investigational Site	Miskolc
Israel	Pfizer Investigational Site	Haifa
Israel	Pfizer Investigational Site	M.P. Lower Galilee
Israel	Pfizer Investigational Site	Petach Tikvah 49202
Israel	Pfizer Investigational Site	Tel Aviv
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Siena
Puerto Rico	Pfizer Investigational Site	Rio Piedras
Slovakia	Pfizer Investigational Site	Bratislava
South Africa	Pfizer Investigational Site	Cape Town	Western Cape, South Africa
Spain	Pfizer Investigational Site	Madrid
Sweden	Pfizer Investigational Site	Stockholm
Ukraine	Pfizer Investigational Site	Donetsk
United Kingdom	Pfizer Investigational Site	Harrow, Middlesex	England
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Chagrin Falls	Ohio
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Elyria	Ohio
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Independence	Ohio
United States	Pfizer Investigational Site	Lakewood	Ohio
United States	Pfizer Investigational Site	Lorain	Ohio
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Solon	Ohio
United States	Pfizer Investigational Site	Strongsville	Ohio
United States	Pfizer Investigational Site	Westlake	Ohio
United States	Pfizer Investigational Site	Willoughby Hills	Ohio
United States	Pfizer Investigational Site	Wooster	Ohio

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Hong Kong,  Hungary,  Israel,  Italy,  Puerto Rico,  Slovakia,  South Africa,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Disease Progression	Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events: Appearance of =20 polyps (>2 mm in size) at any colonoscopy during the study (Polyps); or; Diagnosis of colorectal malignancy (ColMal).	5 years
Secondary	Time to Treatment Failure	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
Secondary	Total Number of Colorectal Polyps	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
Secondary	Colorectal Polyp Burden	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

External Links

•   To obtain contact information for a study center near you, click here.