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Completed

NCT Number: NCT02648048

A Study of Oral Vismodegib in Combination With Pirfenidone in Participants 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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fraunhofer-Institut fur Toxikologie und Experimentelle Medizin ITEM, Hanover, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

Pirfenidone will be administered as per the dosage schedule mentioned in arm description.

Other names: RO0220912

vismodegib

Drug

Vismodegib will be administered as per the dosage schedule mentioned in arm description.

Other names: RO5450815

Primary outcomes

  1. Percentage of Participants with Serious and Non-Serious Adverse Events

    Time frame: 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.

  2. Percentage of Participants with Discontinuation of Any Study Medication Due to a Drug-Related Adverse Event

    Time frame: 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.

  3. Percentage of Participants with Dose Modifications Due to Laboratory Abnormalities and Adverse Events

    Time frame: 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.

  4. Percentage of Participants with Clinically Meaningful Laboratory Abnormalities as Assessed by Investigator

    Time frame: 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.

Secondary outcomes

  1. Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)

    Time frame: 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.

  2. Total and Free Trough Plasma Concentrations of Vismodegib at Week 12 (Cmin, Wk12)

    Time frame: Predose (0 hour) at Week 12

    Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.

  3. Total and Free Trough Plasma Concentrations of Vismodegib at Week 24 (Cmin, Wk24)

    Time frame: Predose (0 hour) at Week 24

    Total plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.

  4. 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 plasma concentration of vismodegib = free (unbound) vismodegib plasma concentration + AAG-bound vismodegib plasma concentration.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: ISLAND2

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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