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Trial record 1 of 2 for:    ipf vismodegib
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A Safety and Tolerability Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02648048
First received: January 5, 2016
Last updated: February 17, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: Pirfenidone Drug: Vismodegib Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of participants with serious and non-serious adverse events [ Time Frame: Up to 28 weeks ]
  • Percentage of participants with discontinuation of any study medication [ Time Frame: Up to Week 24 ]
  • Percentage of participants with dose modifications due to laboratory abnormalities and clinical adverse events [ Time Frame: Up to Week 24 ]
  • Percentage of Participants with Abnormal Vital Signs and Abnormal Clinical Laboratory Parameters, as assessed by Investigator [ Time Frame: Up to 28 weeks ]

Enrollment: 21
Study Start Date: January 2016
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vismodegib+pirfenidone
Participants will receive 150 mg vismodegib once daily and up to 2403 mg pirfenidone daily via oral administration for 24 weeks.
Drug: Pirfenidone
Participants will receive up to 2403 mg pirfenidone daily via oral administration for 24 weeks.
Other Name: RO0220912
Drug: Vismodegib
Participants will receive 150 mg vismodegib once daily via oral administration for 24 weeks.
Other Name: RO5450815

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <=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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02648048

Locations
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
United States, Florida
Central Florida Pulmonary Group, PA
Orlando, Florida, United States, 32803
United States, Illinois
Suburban Lung Associates
Elk Grove, Illinois, United States, 60007
United States, Indiana
Medical Consultants, PC ; Pulmonary
Muncie, Indiana, United States, 47303
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202-1798
United States, Louisiana
Tulane University Medical School
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Steward St. Elizabeth's Medical Center ; Pulmonary, Critical Care and Sleep Medicine
Boston, Massachusetts, United States, 02135
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Allied Clinical Research
Reno, Nevada, United States, 89503
United States, New Jersey
Atlantic Respiratory Institute
Summit, New Jersey, United States, 07901
United States, North Carolina
Pulmonix LLC
Greensboro, North Carolina, United States, 27403
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, Washington
Western Washington Medical Group
Everett, Washington, United States, 98208
Swedish Medical Center
Seattle, Washington, United States, 98122
Germany
Fraunhofer-Institut fur Toxikologie und Experimentelle Medizin ITEM
Hannover, Germany, 30625
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02648048     History of Changes
Other Study ID Numbers: GB29764
2015-003481-81 ( EudraCT Number )
Study First Received: January 5, 2016
Last Updated: February 17, 2017

Keywords provided by Hoffmann-La Roche:
Idiopathic Pulmonary Fibrosis
Vismodegib
Pirfenidone

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2017