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

2017年10月26日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

21

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Pirfenidone
Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
其他名称：
  • RO0220912
药品：Vismodegib
Vismodegib will be administered as per the dosage schedule mentioned in arm description.
其他名称：
  • RO5450815

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants with Serious and Non-Serious Adverse Events
大体时间：Baseline up to 28 weeks
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.
Baseline up to 28 weeks
Percentage of Participants with Discontinuation of Any Study Medication Due to a Drug-Related Adverse Event
大体时间：Baseline up to 28 weeks
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.
Baseline up to 28 weeks
Percentage of Participants with Dose Modifications Due to Laboratory Abnormalities and Adverse Events
大体时间：Baseline up to 28 weeks
An adverse event is any untoward medical occurrence in a participant who receive study drug without regard to possibility of causal relationship.
Baseline up to 28 weeks
Percentage of Participants with Clinically Meaningful Laboratory Abnormalities as Assessed by Investigator
大体时间：Baseline up to 28 weeks
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.
Baseline up to 28 weeks

次要结果测量

结果测量
措施说明
大体时间
Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)
大体时间：Predose (0 hour) at Week 4
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + alpha-1-acid glycoprotein (AAG)-bound vismodegib plasma concentration.
Predose (0 hour) at Week 4
Total and Free Trough Plasma Concentrations of Vismodegib at Week 12 (Cmin, Wk12)
大体时间：Predose (0 hour) at Week 12
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Predose (0 hour) at Week 12
Total and Free Trough Plasma Concentrations of Vismodegib at Week 24 (Cmin, Wk24)
大体时间：Predose (0 hour) at Week 24
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
Predose (0 hour) at Week 24
Total and Free Trough Plasma Concentrations of Vismodegib at Safety Follow-up Visit (Cmin, SFU)
大体时间：At Day 30 post last dose (last dose = 24 weeks) (up to 28 weeks)
Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.
At Day 30 post last dose (last dose = 24 weeks) (up to 28 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hoffmann-La Roche

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年1月15日

初级完成 (实际的)

2016年11月30日

研究完成 (实际的)

2016年11月30日

研究注册日期

首次提交

2016年1月5日

首先提交符合 QC 标准的

2016年1月5日

首次发布 (估计)

2016年1月6日

研究记录更新

最后更新发布 (实际的)

2017年10月30日

上次提交的符合 QC 标准的更新

2017年10月26日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GB29764
  • 2015-003481-81 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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