A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (ISLAND2)

Roche

Status and phase: Completed; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Pirfenidone; Drug: Vismodegib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02648048

2015-003481-81 (EudraCT Number)

GB29764

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Vismodegib and Pirfenidone

Experimental group

Description:

Participants being treated with pirfenidone, will receive vismodegib 150 milligrams (mg) once daily and pirfenidone up to 2403 mg daily orally for 24 weeks.

Treatment:

Drug: Vismodegib

Drug: Pirfenidone