- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02648048
A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (ISLAND2)
October 26, 2017 updated by: Hoffmann-La Roche
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hannover, Germany, 30625
- Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
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California
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La Jolla, California, United States, 92037
- Scripps Clinic
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Florida
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Orlando, Florida, United States, 32803
- Central Florida Pulmonary Group, PA
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Illinois
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Elk Grove, Illinois, United States, 60007
- Suburban Lung Associates
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Indiana
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Muncie, Indiana, United States, 47303
- Medical Consultants, PC ; Pulmonary
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Kentucky
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Louisville, Kentucky, United States, 40202-1798
- University of Louisville
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University Medical School
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Massachusetts
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Boston, Massachusetts, United States, 02135
- Steward St. Elizabeth's Medical Center ; Pulmonary, Critical Care and Sleep Medicine
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
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Nevada
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Reno, Nevada, United States, 89503
- Allied Clinical Research
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New Jersey
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Summit, New Jersey, United States, 07901
- Atlantic Respiratory Institute
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North Carolina
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Greensboro, North Carolina, United States, 27403
- Pulmonix LLC
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Wilmington, North Carolina, United States, 28401
- PMG Research of Wilmington
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Washington
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Everett, Washington, United States, 98208
- Western Washington Medical Group
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Seattle, Washington, United States, 98122
- Swedish Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Vismodegib and Pirfenidone
Participants being treated with pirfenidone, will receive vismodegib 150 milligrams (mg) once daily and pirfenidone up to 2403 mg daily orally for 24 weeks.
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Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
Other Names:
Vismodegib will be administered as per the dosage schedule mentioned in arm description.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants with Serious and Non-Serious Adverse Events
Time Frame: Baseline up to 28 weeks
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An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship.
A serious adverse event is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Baseline up to 28 weeks
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Percentage of Participants with Discontinuation of Any Study Medication Due to a Drug-Related Adverse Event
Time Frame: Baseline up to 28 weeks
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An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship.
Relatedness to the study drug will be assessed by the investigator.
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Baseline up to 28 weeks
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Percentage of Participants with Dose Modifications Due to Laboratory Abnormalities and Adverse Events
Time Frame: Baseline up to 28 weeks
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An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship.
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Baseline up to 28 weeks
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Percentage of Participants with Clinically Meaningful Laboratory Abnormalities as Assessed by Investigator
Time Frame: Baseline up to 28 weeks
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Vital signs and laboratory parameters will be evaluated, and percentage of participants with any clinically meaningful abnormalities as assessed by Investigator will be reported.
Laboratory abnormalities of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade greater than (>) 3 will be considered clinical meaningful.
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Baseline up to 28 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)
Time Frame: Predose (0 hour) at Week 4
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Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + alpha-1-acid glycoprotein (AAG)-bound vismodegib plasma concentration.
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Predose (0 hour) at Week 4
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Total and Free Trough Plasma Concentrations of Vismodegib at Week 12 (Cmin, Wk12)
Time Frame: Predose (0 hour) at Week 12
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Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
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Predose (0 hour) at Week 12
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Total and Free Trough Plasma Concentrations of Vismodegib at Week 24 (Cmin, Wk24)
Time Frame: Predose (0 hour) at Week 24
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Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
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Predose (0 hour) at Week 24
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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)
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Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
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At Day 30 post last dose (last dose = 24 weeks) (up to 28 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2016
Primary Completion (Actual)
November 30, 2016
Study Completion (Actual)
November 30, 2016
Study Registration Dates
First Submitted
January 5, 2016
First Submitted That Met QC Criteria
January 5, 2016
First Posted (Estimate)
January 6, 2016
Study Record Updates
Last Update Posted (Actual)
October 30, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Lung Diseases
- Fibrosis
- Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- GB29764
- 2015-003481-81 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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