Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00131274
• Date of registration: 17/08/2005
• Prospective Registration: No
• Primary sponsor: Daniels, Craig E., M.D.
• Public title: Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study
• Scientific title: A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy (Gleevec Imatinib Mesylate) in Patients With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: April 2003
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00131274
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
• Phase: Phase 2/Phase 3

Contacts

• Name: Craig E Daniels, MD
• Affiliation: Mayo Clinic

• Name: Joseph Lasky, MD
• Affiliation: Tulane University

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 79 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Disease

Idiopathic Pulmonary Fibrosis

Pulmonary Fibrosis

Intervention(s)

Drug: Imatinib Mesylate (Gleevec)

Primary Outcome(s)

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

Secondary Outcome(s)

Change from baseline in % predicted diffusing capacity of the lung for carbon monoxide (DLCO) at 96 weeks

Change in the number of meters walked in the 6 minute walk test at 96 weeks

Change from baseline in the quality of life (QOL) assessments

Mortality at 96 weeks

Change in the modified C-reactive protein (CRP) score at 96 weeks

Change from baseline in high-resolution computed tomography (HRCT) at 96 weeks

Change from baseline in the resting arterial blood gas (ABG) assessment of A-a gradient at 96 weeks

Secondary ID(s)

CST1571E2401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis