A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2016-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Pirfenidone

Criteria

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