Idiopathic Pulmonary FibrosisPhase 2/3NCT00131274
Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study
A Phase 2/3 study testing Imatinib Mesylate (Gleevec) in people with Idiopathic Pulmonary Fibrosis and Lung Disease, run by Daniels, Craig E., M.D..
Trial summary
The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Lung Disease, Pulmonary Fibrosis
- What is being tested?
- Imatinib Mesylate (Gleevec)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Aug 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms consistent with IPF with onset between 3 months and 36 months prior to screening
- Worsening as demonstrated by any one of the following within the past year:
- >10% decrease in FVC % of predicted,
- Worsening chest x-ray or
- Worsening dyspnea at rest or on exertion
- Age 20 -79 years of age. Subjects aged 20-50 must have diagnosis by either open or video-assisted thoracic surgery (VATS) lung biopsy
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- Diagnosis must be made by (HRCT) showing definite or probable IPF AND either of the following:
- Open or VATS lung biopsy showing definite or probable usual interstitial pneumonitis (UIP)
- Non-diagnostic transbronchial biopsy to exclude other conditions (including granulomatous disease and malignancies) AND abnormal pulmonary function tests (reduced FVC or decreased DLCO or impaired gas exchange with rest or exercise) AND 2 of the following:
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- Age >50 years
- Insidious onset of otherwise unexplained dyspnea or exertion
- Bibasilar, inspiratory crackles on examination
- FVC> 55% of predicted value at baseline
- DLCO > 35% of predicted value at screening
- PaO2 >60 mmHg (sea level) or 55 mmHg (altitude) at rest on room air
- Able to understand and willing to provide informed consent prior to any study procedures
Who cannot join
- History of clinically significant environmental exposure known to cause pulmonary fibrosis
- Diagnosis of connective tissue disease
- FEV1/FVC ratio < 0.6 at screening (post-bronchodilator)
- Residual volume > 120% predicted at screening
- Evidence of active infection
- Any condition other than IPF, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year
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- History of unstable or deteriorating cardiac or neurologic disease
- Women with child bearing potential
- Current treatment with corticosteroids, cytoxan, azathioprine, colchicines, pirfenidone, interferon gamma or beta, anti-tumor necrosis factor therapy or with endothelin receptor blockers.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary Fibrosis
The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF).
Read the detailed description
This is a multicenter, double-blind, parallel, placebo-controlled, randomized phase 2 study to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of Idiopathic Pulmonary Fibrosis (IPF). One-hundred- twenty patients will be enrolled in the trial in total. Subjects must have a diagnosis made by HRCT showing definite or probable IPF and clinical symptoms consistent with IPF with onset between 3 and 36 months prior to screening. Subjects will be randomly assigned to receive either Gleevec 600 mg orally or placebo, once per day for approximately 2 years. The primary efficacy will be progression defined as a greater than 10% decline in the forced vital capacity or death. Measures of safety will include all randomized patients who receive at least one dose of study medication. All adverse events and serious adverse events will be separately tabulated and mapped to a standard classification system and grouped by body system. Any serious adverse events that occur during the trial and 30 days after the end of therapy will be reported to the FDA within 24 hours and followed to outcome.
- Being tested
- Imatinib Mesylate (Gleevec)
- Keywords
- Pulmonary Fibrosis, Respiratory Diseases, Interstitial Lung Disease, Usual Interstitial Pneumonia
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Pulmonary Fibrosis, Respiratory Tract Diseases, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib Mesylate (Gleevec)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression defined as a greater than 10% decline in the forced vital capacity (FVC) or death
Secondary outcomes (7)
Change from baseline in % predicted diffusing capacity of the lung for carbon monoxide (DLCO) at 96 weeks
Change from baseline in the resting arterial blood gas (ABG) assessment of A-a gradient at 96 weeks
Change in the number of meters walked in the 6 minute walk test at 96 weeks
Change from baseline in high-resolution computed tomography (HRCT) at 96 weeks
Change from baseline in the quality of life (QOL) assessments
Change in the modified C-reactive protein (CRP) score at 96 weeks
Mortality at 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startApr 2003
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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 2/3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Daniels, Craig E., M.D.
- Collaborators
- Novartis
- Investigators
- Craig E Daniels, MD, Principal investigator, Mayo ClinicJoseph Lasky, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131274
- Sponsor's protocol ID
- CST1571E2401
- Status last verified
- Aug 2005
- First submitted
- 17 Aug 2005
- Last updated
- 5 Oct 2005
- Results posted
- No
Publications
Daniels CE, Lasky JA, Limper AH, Mieras K, Gabor E, Schroeder DR; Imatinib-IPF Study Investigators. Imatinib treatment for idiopathic pulmonary fibrosis: Randomized placebo-controlled trial results. Am J Respir Crit Care Med. 2010 Mar 15;181(6):604-10. doi: 10.1164/rccm.200906-0964OC. Epub 2009 Dec 10.
PubMed 20007927
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00131274
- Acronym / sponsor ID
- CST1571E2401
- Keywords
- Pulmonary Fibrosis, Respiratory Diseases, Interstitial Lung Disease, Usual Interstitial Pneumonia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Daniels, Craig E., M.D.
- Collaborators
- Novartis
- Study start
- Apr 2003
- Study completion
- Aug 2007
- First posted
- 18 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF).
Detailed description
This is a multicenter, double-blind, parallel, placebo-controlled, randomized phase 2 study to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of Idiopathic Pulmonary Fibrosis (IPF). One-hundred- twenty patients will be enrolled in the trial in total. Subjects must have a diagnosis made by HRCT showing definite or probable IPF and clinical symptoms consistent with IPF with onset between 3 and 36 months prior to screening. Subjects will be randomly assigned to receive either Gleevec 600 mg orally or placebo, once per day for approximately 2 years. The primary efficacy will be progression defined as a greater than 10% decline in the forced vital capacity or death. Measures of safety will include all randomized patients who receive at least one dose of study medication. All adverse events and serious adverse events will be separately tabulated and mapped to a standard classification system and grouped by body system. Any serious adverse events that occur during the trial and 30 days after the end of therapy will be reported to the FDA within 24 hours and followed to outcome.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Clinical symptoms consistent with IPF with onset between 3 months and 36 months prior to screening
- Worsening as demonstrated by any one of the following within the past year:
- Age 20 -79 years of age. Subjects aged 20-50 must have diagnosis by either open or video-assisted thoracic surgery (VATS) lung biopsy
- Diagnosis must be made by (HRCT) showing definite or probable IPF AND either of the following:
- <!-- -->
Key exclusion criteria (9 listed)
- History of clinically significant environmental exposure known to cause pulmonary fibrosis
- Diagnosis of connective tissue disease
- FEV1/FVC ratio < 0.6 at screening (post-bronchodilator)
- Residual volume > 120% predicted at screening
- Evidence of active infection
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 |
|---|---|---|
| Imatinib Mesylate (Gleevec) | Drug | – |
Primary outcome
Progression defined as a greater than 10% decline in the forced vital capacity (FVC) or death
7 secondary outcomes
Change from baseline in % predicted diffusing capacity of the lung for carbon monoxide (DLCO) at 96 weeks
Change from baseline in the resting arterial blood gas (ABG) assessment of A-a gradient at 96 weeks
Change in the number of meters walked in the 6 minute walk test at 96 weeks
Change from baseline in high-resolution computed tomography (HRCT) at 96 weeks
Change from baseline in the quality of life (QOL) assessments
Change in the modified C-reactive protein (CRP) score at 96 weeks
Mortality at 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2005.
- Derived from this study: PubMed 20007927Daniels CE, Lasky JA, Limper AH, Mieras K, Gabor E, Schroeder DR; Imatinib-IPF Study Investigators. Imatinib treatment for idiopathic pulmonary fibrosis: Randomized placebo-controlled trial results. Am J Respir Crit Care Med. 2010 Mar 15;181(6):604-10. doi: 10.1164/rccm.200906-0964OC. Epub 2009 Dec 10.
- Related InfoLink provided by the sponsor.
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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.
Craig E Daniels, MD principal investigator
Mayo Clinic
Joseph Lasky, MD principal investigator
Tulane University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Imatinib Mesylate (Gleevec) in people with Idiopathic Pulmonary Fibrosis and Lung Disease, run by Daniels, Craig E., M.D..
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 17 inclusion and 9 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: finished, as of the sponsor's last update on 5 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression defined as a greater than 10% decline in the forced vital capacity (FVC) or death. 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 NCT00131274, which also lists 1 linked publication.
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 5 Oct 2005.