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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02648048
• Date of registration: 05/01/2016
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis ISLAND2
• Scientific title: 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
• Date of first enrolment: January 15, 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02648048
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Germany, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Pirfenidone

Drug: Vismodegib

Primary Outcome(s)

Percentage of Participants with Discontinuation of Any Study Medication Due to a Drug-Related Adverse Event [Time Frame: Baseline up to 28 weeks]

Percentage of Participants with Serious and Non-Serious Adverse Events [Time Frame: Baseline up to 28 weeks]

Percentage of Participants with Clinically Meaningful Laboratory Abnormalities as Assessed by Investigator [Time Frame: Baseline up to 28 weeks]

Percentage of Participants with Dose Modifications Due to Laboratory Abnormalities and Adverse Events [Time Frame: Baseline up to 28 weeks]

Secondary Outcome(s)

Total and Free Trough Plasma Concentrations of Vismodegib at Week 12 (Cmin, Wk12) [Time Frame: Predose (0 hour) at Week 12]

Total and Free Trough Plasma Concentrations of Vismodegib at Week 24 (Cmin, Wk24) [Time Frame: Predose (0 hour) at Week 24]

Total and Free Trough Plasma Concentrations of Vismodegib at Safety Follow-up Visit (Cmin, SFU) [Time Frame: At Day 30 post last dose (last dose = 24 weeks) (up to 28 weeks)]

Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4) [Time Frame: Predose (0 hour) at Week 4]

Secondary ID(s)

2015-003481-81

GB29764

Source(s) of Monetary Support

Please refer to primary and secondary sponsors