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

26. oktober 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

21

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Pirfenidone
Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
Andre navne:
  • RO0220912
Medicin: Vismodegib
Vismodegib will be administered as per the dosage schedule mentioned in arm description.
Andre navne:
  • RO5450815

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants with Serious and Non-Serious Adverse Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total and Free Trough Plasma Concentrations of Vismodegib at Week 4 (Cmin, Wk4)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. januar 2016

Primær færdiggørelse (Faktiske)

30. november 2016

Studieafslutning (Faktiske)

30. november 2016

Datoer for studieregistrering

Først indsendt

5. januar 2016

Først indsendt, der opfyldte QC-kriterier

5. januar 2016

Først opslået (Skøn)

6. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Idiopatisk lungefibrose

Kliniske forsøg med Pirfenidone

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner