Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

NCT00585312 | Terminated Phase 3 Results DMC

• 1 other identifier: A3191193
• Study Type: interventional
• Target: 106
• Locations: 14 countries
• Sites: 42

Brief Summary

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

Conditions

Adenomatous Polyposis Coli

Keywords

FAP

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (3)

• Time to Treatment Failure

  5 years

• Total Number of Colorectal Polyps

  Years 1 - 5

• Colorectal Polyp Burden

  Years 1 - 5

Study Arms (2)

Celecoxib

EXPERIMENTAL

celecoxib, 16 mg/kg/day, for 5 years

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

Masked, placebo comparator

Drug: Placebo

Interventions

Celecoxib DRUG

celecoxib, 16 mg/kg/day, for 5 years

Also known as: celebrex, SC-58635

Celecoxib

Placebo DRUG

Masked, placebo comparator

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (42)

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68114, United States

Location

Pfizer Investigational Site

New York, New York, 10017, United States

Location

Pfizer Investigational Site

New York, New York, 10022, United States

Location

Pfizer Investigational Site

New York, New York, 10065, United States

Location

Pfizer Investigational Site

Chagrin Falls, Ohio, 44136, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44122, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Elyria, Ohio, 44035, United States

Location

Pfizer Investigational Site

Independence, Ohio, 44131, United States

Location

Pfizer Investigational Site

Lakewood, Ohio, 44107, United States

Location

Pfizer Investigational Site

Lorain, Ohio, 44053, United States

Location

Pfizer Investigational Site

Solon, Ohio, 44138, United States

Location

Pfizer Investigational Site

Strongsville, Ohio, 44136, United States

Location

Pfizer Investigational Site

Westlake, Ohio, 44145, United States

Location

Pfizer Investigational Site

Willoughby Hills, Ohio, 44094, United States

Location

Pfizer Investigational Site

Wooster, Ohio, 44691, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030-4990, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84112, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84132, United States

Location

Pfizer Investigational Site

Brussels, 1200, Belgium

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Prague, 150 06, Czechia

Location

Pfizer Investigational Site

Shatin, New Territories, 0, Hong Kong

Location

Pfizer Investigational Site

Hong Kong, 150001, Hong Kong

Location

Pfizer Investigational Site

Miskolc, 3501, Hungary

Location

Pfizer Investigational Site

Haifa, 31096, Israel

Location

Pfizer Investigational Site

M.P. Lower Galilee, 15208, Israel

Location

Pfizer Investigational Site

Petach Tikvah 49202, Israel

Location

Pfizer Investigational Site

Tel Aviv, 64239, Israel

Location

Pfizer Investigational Site

Roma, 00144, Italy

Location

Pfizer Investigational Site

Siena, 53100, Italy

Location

Pfizer Investigational Site

Rio Piedras, 00935, Puerto Rico

Location

Pfizer Investigational Site

Bratislava, 833 40, Slovakia

Location

Pfizer Investigational Site

Cape Town, Western Cape, South Africa, 7925, South Africa

Location

Pfizer Investigational Site

Madrid, 28040, Spain

Location

Pfizer Investigational Site

Stockholm, 17176, Sweden

Location

Pfizer Investigational Site

Donetsk, 83052, Ukraine

Location

Pfizer Investigational Site

Harrow, Middlesex, England, HA1 3UJ, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was early terminated and, due to the low number of participants, no efficacy analysis was performed. Only descriptive statistics was performed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2008
• First Posted: January 3, 2008
• Study Start: September 1, 2006
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 21, 2021
• Results First Posted: November 3, 2014

Record last verified: 2021-02

Locations

HK (2); PR (1); IL (4); ES (1); IT (2); SE (1); BE (2); UA (1); GB (1); CZ (1); HU (1); ZA (1); US (23); SL (1)