Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT02648048

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Pirfenidone, Vismodegib

Countries: United States, Germany

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.

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (15)
  • La Jolla, California, United States
  • Orlando, Florida, United States
  • Elk Grove, Illinois, United States
  • Muncie, Indiana, United States
  • Louisville, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Omaha, Nebraska, United States
  • Reno, Nevada, United States
  • Summit, New Jersey, United States
  • Greensboro, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Everett, Washington, United States
  • Seattle, Washington, United States
  • Hanover, Germany