IRB Number:

493-03

Trial Status:

Inactive

Phase: II

Why is this study being done?

The purpose of this research study is to evaluate the safety and efficacy of Gleevec (imitanib mesylate) in the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Who is Eligible to Participate in the Study?

Eligibility Criteria:

• 20 - 79 years of age


• clinical symptoms consistent with IPF with onset between 3 months and 36 months prior to screening


• 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 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

Minimum Age:

20

Maximum Age:

79

How long will the Study run?

Participation in this research study will require 29 visits over the course of two years.

Who can I Contact for Additional Information on this Trial?

Principal Investigators:
Andrew H. Limper, M.D.
Craig A. Daniels, M.D.

Study Coordinators:
Kim Carlson (507) 284-4862
Kathy Mieras (507) 284-9187

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 10/05/2005