Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniels, Craig E., M.D.
• Collaborator: Novartis
• Treatments: Imatinib Mesylate

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.