Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study

NCT00131274 | Completed Phase 2

• 1 other identifier: CST1571E2401
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Idiopathic Pulmonary Fibrosis; Lung Disease; Pulmonary Fibrosis

Keywords

Pulmonary Fibrosis; Respiratory Diseases; Interstitial Lung Disease; Usual Interstitial Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Imatinib Mesylate (Gleevec) DRUG

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
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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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniels, Craig E., M.D.: lead
• Novartis: collaborator

Related Publications (1)

• 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.

  PMID: 20007927 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases; Pulmonary Fibrosis; Respiratory Tract Diseases; Lung Diseases, Interstitial

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Craig E Daniels, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Joseph Lasky, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: ECT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 18, 2005
• Study Start: April 1, 2003
• Study Completion: August 1, 2007
• Last Updated: October 5, 2005

Record last verified: 2005-08