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A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
- Respiratory Disorder
- Idiopathic Pulmonary Fibrosis (IPF)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Boston
- Elk Grove Village
- Everett
- Greensboro
- Hannover
- Louisville
- Muncie
- New Orleans
- Omaha
- Orlando
- Reno
- San Diego
- Seattle
- Summit
- Wilmington
Trial Identifier:
NCT02648048 2015-003481-81 GB29764
Trial Summary
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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT02648048, GB29764, 2015-003481-81
Trial Identifier
Pirfenidone, Vismodegib
Treatments
Idiopathic Pulmonary Fibrosis
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥ 40 Years & ≤ 80 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com