Adenomatous Polyposis ColiPhase 3CHIPNCT00585312

Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)

A Phase 3 study testing Celecoxib in people with Adenomatous Polyposis Coli, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 42 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Adenomatous Polyposis Coli
What is being tested?: Celecoxib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: 42 sitesin 14 countries
Study dates: Sep 2006to Oct 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

42 sites in 14 countries.

Country

City, postcode or hospital

42 sites in 14 countries

United States23 sites

Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Chagrin Falls, Ohio, 44136
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Elyria, Ohio, 44035
Pfizer Investigational Site
Houston, Texas, 77030-4990
Pfizer Investigational Site
Independence, Ohio, 44131
Pfizer Investigational Site
Lakewood, Ohio, 44107
Pfizer Investigational Site
Lorain, Ohio, 44053
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New York, New York, 10017
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
New York, New York, 10065
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Salt Lake City, Utah, 84112
Pfizer Investigational Site
Salt Lake City, Utah, 84132
Pfizer Investigational Site
Solon, Ohio, 44138
Pfizer Investigational Site
Strongsville, Ohio, 44136
Pfizer Investigational Site
Westlake, Ohio, 44145
Pfizer Investigational Site
Willoughby Hills, Ohio, 44094
Pfizer Investigational Site
Wooster, Ohio, 44691

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Israel4 sites

Pfizer Investigational Site
Haifa, 31096
Pfizer Investigational Site
M.P. Lower Galilee, 15208
Pfizer Investigational Site
Petach Tikvah 49202
Pfizer Investigational Site
Tel Aviv, 64239

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Belgium2 sites

Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Ghent, 9000

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Hong Kong2 sites

Pfizer Investigational Site
Hong Kong, 150001
Pfizer Investigational Site
Shatin, New Territories, 0

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Italy2 sites

Pfizer Investigational Site
Roma, 00144
Pfizer Investigational Site
Siena, 53100

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Czechia1 site

Pfizer Investigational Site
Prague, 150 06

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Hungary1 site

Pfizer Investigational Site
Miskolc, 3501

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Puerto Rico1 site

Pfizer Investigational Site
Rio Piedras, 00935

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Slovakia1 site

Pfizer Investigational Site
Bratislava, 833 40

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South Africa1 site

Pfizer Investigational Site
Cape Town, Western Cape, South Africa, 7925

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Spain1 site

Pfizer Investigational Site
Madrid, 28040

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Sweden1 site

Pfizer Investigational Site
Stockholm, 17176

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Ukraine1 site

Pfizer Investigational Site
Donetsk, 83052

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United Kingdom1 site

Pfizer Investigational Site
Harrow, Middlesex, England, HA1 3UJ

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About this study

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

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

Read the 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.

Conditions: Adenomatous Polyposis Coli
Being tested: Celecoxib, Placebo
Keywords: FAP
Medical subject headings: Adenomatous Polyposis Coli

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
Also called celebrex, SC-58635
celecoxib, 16 mg/kg/day, for 5 years
PlaceboDrug
Masked, placebo comparator

Study groups in NCT00585312
Study group	Role	What they receive
Celecoxib	Experimental	celecoxib, 16 mg/kg/day, for 5 years Receives: Drug: Celecoxib
Placebo	Placebo comparator	Masked, placebo comparator Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 5 years

Secondary outcomes (3)

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.
Measured: 5 years
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.
Measured: Years 1 - 5
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.
Measured: Years 1 - 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Oct 2013

First posted3 Jan 2008 (estimated)
Study startSep 2006
Primary completionOct 2013
Study completionOct 2013

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adenomatous Polyposis ColiStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00585312
Sponsor's protocol ID: A3191193
Acronym: CHIP
Status last verified: Feb 2021
First submitted: 1 Jan 2008
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Enrolling by invitation
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
FAP, Familial Adenomatous Polyposis
RecruitingPhase 2
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Colorectal Carcinoma, Familial Adenomatous Polyposis
Recruiting
An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results
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All Adenomatous Polyposis Coli trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis
ClinicalTrials.gov ID: NCT00585312
Acronym / sponsor ID: CHIP / A3191193
Conditions: Adenomatous Polyposis Coli
Keywords: FAP
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 106 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 3 Jan 2008 (estimated)
Results: Posted 3 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Celecoxib	Experimental	Drug: Celecoxibcelecoxib, 16 mg/kg/day, for 5 years
Placebo	Placebo comparator	Drug: PlaceboMasked, placebo comparator

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CelecoxibAlso: celebrex, SC-58635celecoxib, 16 mg/kg/day, for 5 years	Drug	Celecoxib
PlaceboMasked, placebo comparator	Drug	Placebo

Primary outcome

Time to Disease Progression
Time frame: 5 years
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).

3 secondary outcomes

Time to Treatment Failure
Time frame: 5 years
Total Number of Colorectal Polyps
Time frame: Years 1 - 5
Colorectal Polyp Burden
Time frame: Years 1 - 5

Results and safety

Results posted to the registry on 3 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Celecoxib	55	4
Placebo	51	7

Primary outcome: Time to Disease Progression

Time frame: 5 years. Mean (Standard Deviation). Unit: years

Measure	Celecoxib n = 7	Placebo n = 13
Value	2.2 (1.08)	1.8 (1.30)

Population analysed: ITT population (N: 106) consisted of all participants who were randomized and assigned to treatment. Primary outcome measure was met by 7 (Polyp:7,ColMal:0) participants in the Celecoxib group and 13 (13,0) in the placebo group. Study was early terminated due to low enrollment and lower than expected endpoint rate. No analysis was performed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events were reported from randomization through and including 30 calendar days after the last administration of the study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib	3 of 53 (5.7%)	36 of 53 (67.9%)	Not reported
Placebo	0 of 48 (0%)	30 of 48 (62.5%)	Not reported

Limitations and caveats (from the sponsor): The study was early terminated and, due to the low number of participants, no efficacy analysis was performed. Only descriptive statistics was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Adenomatous Polyposis Coli

RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Enrolling by invitation
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
FAP, Familial Adenomatous Polyposis
RecruitingPhase 2
An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
Colorectal Carcinoma, Familial Adenomatous Polyposis
Recruiting
An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results
BRCA1 Mutation, POLD1 Gene Mutation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

42 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celecoxib in people with Adenomatous Polyposis Coli, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 42 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Israel, Belgium, Hong Kong, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Disease Progression (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00585312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.