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

Completed · Phase 1

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID: NCT02648048
Run by: Hoffmann-La Roche
People needed: 21
Starts: 2016-01-15
Expected to finish: 2016-11-30
Last updated by the study team: 2017-10-30

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Scripps Clinic — La Jolla, California, United States
Central Florida Pulmonary Group, PA — Orlando, Florida, United States
Suburban Lung Associates — Elk Grove, Illinois, United States
Medical Consultants, PC ; Pulmonary — Muncie, Indiana, United States
University of Louisville — Louisville, Kentucky, United States
Tulane University Medical School — New Orleans, Louisiana, United States
Steward St. Elizabeth's Medical Center ; Pulmonary, Critical Care and Sleep Medicine — Boston, Massachusetts, United States
Creighton University Medical Center — Omaha, Nebraska, United States
Allied Clinical Research — Reno, Nevada, United States
Atlantic Respiratory Institute — Summit, New Jersey, United States
Pulmonix LLC — Greensboro, North Carolina, United States
PMG Research of Wilmington — Wilmington, North Carolina, United States
Western Washington Medical Group — Everett, Washington, United States
Swedish Medical Center — Seattle, Washington, United States
Fraunhofer-Institut fur Toxikologie und Experimentelle Medizin ITEM — Hanover, Germany

Full record on ClinicalTrials.gov

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