A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
NCT ID: NCT02648048
Last Updated: 2017-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2016-01-15
2016-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Pirfenidone
Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
Vismodegib
Vismodegib will be administered as per the dosage schedule mentioned in arm description.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pirfenidone
Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
Vismodegib
Vismodegib will be administered as per the dosage schedule mentioned in arm description.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Scripps Clinic
La Jolla, California, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
Suburban Lung Associates
Elk Grove, Illinois, United States
Medical Consultants, PC ; Pulmonary
Muncie, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University Medical School
New Orleans, Louisiana, United States
Steward St. Elizabeth's Medical Center ; Pulmonary, Critical Care and Sleep Medicine
Boston, Massachusetts, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Allied Clinical Research
Reno, Nevada, United States
Atlantic Respiratory Institute
Summit, New Jersey, United States
Pulmonix LLC
Greensboro, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Western Washington Medical Group
Everett, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Fraunhofer-Institut fur Toxikologie und Experimentelle Medizin ITEM
Hanover, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Prasse A, Ramaswamy M, Mohan S, Pan L, Kenwright A, Neighbors M, Belloni P, LaCamera PP. A Phase 1b Study of Vismodegib with Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. Pulm Ther. 2019 Dec;5(2):151-163. doi: 10.1007/s41030-019-0096-8. Epub 2019 Jul 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-003481-81
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB29764
Identifier Type: -
Identifier Source: org_study_id