A Study of Oral Vismodegib in Combination With Pirfenidon... | NCT02648048

ID	Type	Description	Link
2015-003481-81	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vismodegib and Pirfenidone	Experimental	Participants being treated with pirfenidone, will receive vismodegib 150 milligrams (mg) once daily and pirfenidone up to 2403 mg daily orally for 24 weeks.	Drug: Pirfenidone Drug: Vismodegib

Name	Type	Description	Arm Group Labels	Other Names
Pirfenidone	Drug	Pirfenidone will be administered as per the dosage schedule mentioned in arm description.	Vismodegib and Pirfenidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Serious and Non-Serious Adverse Events	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	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	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	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

Secondary Outcomes

Measure	Description	Time Frame
Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)	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)

Eligibility Module

Eligibility 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 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

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Clinic		La Jolla	California	92037	United States
Central Florida Pulmonary Group, PA

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C093844	pirfenidone
C538724	HhAntag691