A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
Status: | Completed |
---|---|
Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 40 - 80 |
Updated: | 11/1/2017 |
Start Date: | January 15, 2016 |
End Date: | November 30, 2016 |
A Single Arm, Multicenter, Open-label, Phase 1b Study to Assess the Safety and Tolerability of Oral Vismodegib in Combination With Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and
tolerability of vismodegib in combination with pirfenidone in participants with idiopathic
pulmonary fibrosis (IPF) currently being treated with pirfenidone.
tolerability of vismodegib in combination with pirfenidone in participants with idiopathic
pulmonary fibrosis (IPF) currently being treated with pirfenidone.
Inclusion Criteria:
- Have a diagnosis of IPF 5 years from time of screening, confirmed at baseline
- Tolerated dose of pirfenidone 1602-2403 mg once daily (QD) for a minimum of 24 weeks
required prior to and during screening
- Greater than or equal to (>=) 50 percent (%) and less than or equal to (<=) 100% of
predicted forced vital capacity (FVC) at screening
- Stable baseline lung function as evidenced by a difference of less than (<) 10% in
absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to
enrollment
- >=30% and <=90% of predicted diffusion capacity of the lung for carbon monoxide at
screening
- Agree to use protocol defined methods of contraception
- Male participants must agree not to donate semen during the study and for at least 2
months (or as per local requirements) after the last dose of vismodegib
- Agree not to donate blood or blood products during the study and for at least 9 months
(or as per local requirements) after the last dose of study treatment
Exclusion Criteria:
- Prior treatment with vismodegib or any Hh-pathway inhibitor
- Evidence of other known causes of interstitial lung disease
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during
screening
- Lung transplant expected within 6 months of screening
- Evidence of clinically significant lung disease other than IPF
- Post-bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at screening
- Any clinically significant medical disease (other than IPF) that is associated with an
expected survival of <6 months, likely to require a change in therapy during the study
- Class IV New York Heart Association chronic heart failure or historical evidence of
left ventricular ejection fraction <35%
- Known current malignancy or current evaluation for a potential malignancy
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus
infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Creatinine clearance <=30 milliliter per minute, calculated using the Cockcroft-Gault
formula
We found this trial at
15
sites
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Boston, Massachusetts 02135
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1 Nikolai-Fuchs-Straße
Hannover, 30625
Hannover, 30625
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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University of Louisville The University of Louisville is a state supported research university located in...
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Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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