Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Daniels, Craig E., M.D.
ClinicalTrials.gov Identifier:
NCT00131274
First received: August 17, 2005
Last updated: October 4, 2005
Last verified: August 2005
  Purpose

The purpose of the study is to evaluate the safety and efficacy of Gleevec (imatinib mesylate) in the treatment of idiopathic pulmonary fibrosis (IPF).


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Lung Disease
Pulmonary Fibrosis
Drug: Imatinib Mesylate (Gleevec)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Daniels, Craig E., M.D.:

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

Estimated Enrollment: 120
Study Start Date: April 2003
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    1. >10% decrease in FVC % of predicted,
    2. Worsening chest x-ray or
    3. 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:

    1. Open or VATS lung biopsy showing definite or probable usual interstitial pneumonitis (UIP)
    2. 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:
    1. Age >50 years
    2. Insidious onset of otherwise unexplained dyspnea or exertion
    3. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131274

Sponsors and Collaborators
Daniels, Craig E., M.D.
Novartis
Investigators
Principal Investigator: Craig E Daniels, MD Mayo Clinic
Principal Investigator: Joseph Lasky, MD Tulane University
  More Information

Additional Information:
No publications provided by Daniels, Craig E., M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131274     History of Changes
Other Study ID Numbers: CST1571E2401
Study First Received: August 17, 2005
Last Updated: October 4, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Daniels, Craig E., M.D.:
Pulmonary Fibrosis
Respiratory Diseases
Interstitial Lung Disease
Usual Interstitial Pneumonia

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014