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

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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.


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
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Elk Grove, Illinois 60007
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326 North Mills Avenue
Orlando, Florida 32803
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Boston, MA
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Everett, Washington 98208
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Greensboro, North Carolina 27403
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Hannover,
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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800 Tillotson Avenue
Muncie, Indiana 47303
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Muncie, IN
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New Orleans, Louisiana 70112
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New Orleans, LA
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601 N 30th St
Omaha, Nebraska 68131
(402) 449-4000
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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Reno, Nevada 89503
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Reno, NV
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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99 Beauvoir Avenue
Summit, New Jersey 07901
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Summit, NJ
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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Wilmington, NC
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