Clinical trial NCT00585312: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Adenomatous Polyposis Coli
Keywords: FAP
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-03
Enrollment: 106
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time to Disease Progression
timeFrame: 5 years
Secondary outcomes:
measure: Time to Treatment Failure
timeFrame: 5 years
measure: Total Number of Colorectal Polyps
timeFrame: Years 1 - 5
measure: Colorectal Polyp Burden
timeFrame: Years 1 - 5
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Chagrin Falls
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Elyria
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Independence
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lorain
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Solon
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Strongsville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Westlake
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Willoughby Hills
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Wooster
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Praha
country: Czechia
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
state: New Territories
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Miskolc
country: Hungary
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: M.P. Lower Galilee
country: Israel
facility: Pfizer Investigational Site
city: Petach Tikvah 49202
country: Israel
facility: Pfizer Investigational Site
city: Tel Aviv
country: Israel
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Rio Piedras
country: Puerto Rico
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape, South Africa
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Harrow, Middlesex
country: United Kingdom
facility: Pfizer Investigational Site
state: England
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: