Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) - Clinical Trial for Adenomatous Polyposis Coli | NCT00585312

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Celecoxib

Placebo

About this trial

This is an interventional prevention trial for Adenomatous Polyposis Coli focused on measuring FAP

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Celecoxib

Placebo

Arm Description

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

Masked, placebo comparator

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT00585312

First Posted

January 1, 2008

Last Updated

February 18, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00585312

Brief Title

Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

Acronym

CHIP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

September 2006 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenomatous Polyposis Coli

Keywords

FAP

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Celecoxib

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Masked, placebo comparator

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Other Intervention Name(s)

celebrex, SC-58635

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Masked, placebo comparator

Primary Outcome Measure Information:

Title

Time to Disease Progression

Description

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).

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Time to Treatment Failure

Description

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.

Time Frame

5 years

Title

Total Number of Colorectal Polyps

Description

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.

Time Frame

Years 1 - 5

Title

Colorectal Polyp Burden

Description

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.

Time Frame

Years 1 - 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Pfizer Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Pfizer Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10017

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Pfizer Investigational Site

City

Chagrin Falls

State/Province

Ohio

ZIP/Postal Code

44136

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Pfizer Investigational Site

City

Elyria

State/Province

Ohio

ZIP/Postal Code

44035

Country

United States

Facility Name

Pfizer Investigational Site

City

Independence

State/Province

Ohio

ZIP/Postal Code

44131

Country

United States

Facility Name

Pfizer Investigational Site

City

Lakewood

State/Province

Ohio

ZIP/Postal Code

44107

Country

United States

Facility Name

Pfizer Investigational Site

City

Lorain

State/Province

Ohio

ZIP/Postal Code

44053

Country

United States

Facility Name

Pfizer Investigational Site

City

Solon

State/Province

Ohio

ZIP/Postal Code

44138

Country

United States

Facility Name

Pfizer Investigational Site

City

Strongsville

State/Province

Ohio

ZIP/Postal Code

44136

Country

United States

Facility Name

Pfizer Investigational Site

City

Westlake

State/Province

Ohio

ZIP/Postal Code

44145

Country

United States

Facility Name

Pfizer Investigational Site

City

Willoughby Hills

State/Province

Ohio

ZIP/Postal Code

44094

Country

United States

Facility Name

Pfizer Investigational Site

City

Wooster

State/Province

Ohio

ZIP/Postal Code

44691

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4990

Country

United States

Facility Name

Pfizer Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Pfizer Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Pfizer Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Pfizer Investigational Site

City

Shatin

State/Province

New Territories

ZIP/Postal Code

0

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Hong Kong

ZIP/Postal Code

150001

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Miskolc

ZIP/Postal Code

3501

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Pfizer Investigational Site

City

M.P. Lower Galilee

ZIP/Postal Code

15208

Country

Israel

Facility Name

Pfizer Investigational Site

City

Petach Tikvah 49202

Country

Israel

Facility Name

Pfizer Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Pfizer Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Rio Piedras

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

Bratislava

ZIP/Postal Code

833 40

Country

Slovakia

Facility Name

Pfizer Investigational Site

City

Cape Town

State/Province

Western Cape, South Africa

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Pfizer Investigational Site

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Donetsk

ZIP/Postal Code

83052

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Harrow, Middlesex

State/Province

England

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191193&StudyName=Trial%20In%20Pediatric%20Patients%20With%20Familial%20Adenomatous%20Polyposis%20%28FAP%29%0A

Description

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

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

Adenomatous Polyposis Coli

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial