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Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study

Primary Purpose

Idiopathic Pulmonary Fibrosis, Lung Disease, Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imatinib Mesylate (Gleevec)
Sponsored by
Daniels, Craig E., M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Idiopathic Pulmonary Fibrosis focused on measuring Pulmonary Fibrosis, Respiratory Diseases, Interstitial Lung Disease, Usual Interstitial Pneumonia

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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: 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 Exclusion Criteria: 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 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Progression defined as a greater than 10% decline in the forced vital capacity (FVC) or death

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    August 17, 2005
    Last Updated
    October 4, 2005
    Sponsor
    Daniels, Craig E., M.D.
    Collaborators
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00131274
    Brief Title
    Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study
    Official Title
    A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2007 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Daniels, Craig E., M.D.
    Collaborators
    Novartis

    4. Oversight

    5. Study Description

    Brief 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Pulmonary Fibrosis, Lung Disease, Pulmonary Fibrosis
    Keywords
    Pulmonary Fibrosis, Respiratory Diseases, Interstitial Lung Disease, Usual Interstitial Pneumonia

    7. Study Design

    Primary Purpose
    Educational/Counseling/Training
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    120 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Imatinib Mesylate (Gleevec)
    Primary Outcome Measure Information:
    Title
    Progression defined as a greater than 10% decline in the forced vital capacity (FVC) or death
    Secondary Outcome Measure Information:
    Title
    Change from baseline in % predicted diffusing capacity of the lung for carbon monoxide (DLCO) at 96 weeks
    Title
    Change from baseline in the resting arterial blood gas (ABG) assessment of A-a gradient at 96 weeks
    Title
    Change in the number of meters walked in the 6 minute walk test at 96 weeks
    Title
    Change from baseline in high-resolution computed tomography (HRCT) at 96 weeks
    Title
    Change from baseline in the quality of life (QOL) assessments
    Title
    Change in the modified C-reactive protein (CRP) score at 96 weeks
    Title
    Mortality at 96 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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: 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 Exclusion Criteria: 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 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Craig E Daniels, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Joseph Lasky, MD
    Organizational Affiliation
    Tulane University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20007927
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.pulmonaryfibrosis.org/
    Description
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