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    Summary
    EudraCT Number:2014-000963-42
    Sponsor's Protocol Code Number:GB29298
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-000963-42
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, phase II study to assess the efficacy and safety of oral vismodegib for the treatment of idiopathic pulmonary fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study to assess vismodegib in the treatment of idiopathic pulmonary fibrosis
    A.3.2Name or abbreviated title of the trial where available
    ISLAND
    A.4.1Sponsor's protocol code numberGB29298
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Erivedge
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvismodegib
    D.3.9.1CAS number 879085-55-9
    D.3.9.3Other descriptive nameVISMODEGIB
    D.3.9.4EV Substance CodeSUB32354
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic pulmonary fibrosis
    E.1.1.1Medical condition in easily understood language
    Pulmonary fibrosis
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Change in pulmonary function (FVC% predicted) from baseline to week 52
    E.2.2Secondary objectives of the trial
    - Change in diffusion capacity of the lung for carbon dioxide (DLco)
    - Change in pulmonary function: annualized rate of change in FVC
    - Progression-free survival
    - Acute IPF exacerbations
    - Change in quality of life measurement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > or equal to 40 years at Visit 1
    - Have a diagnosis of IPF based upon the ATS/ERS/JRS/ALAT consensus statement on IPF (Raghu et al. 2011) within the previous 5 years from time of screening and confirmed at baseline Have a central review assessment of HRCT performed during the screening period or < or equal to 12 months prior to the start of screening
    - Patients from countries where a treatment is licensed/approved for IPF must additionally meet at least one of the following criteria to be eligible;
    - Be unable to access a licensed therapy for IPF
    - Treatment with a licensed therapy/therapies has been stopped for lack of efficacy or because of safety/tolerability reasons (a period of washout will be required; refer to Section 4.1.2)
    - Be unwilling to be treated with a licensed/approved therapy and after having reviewed all available treatment options, the investigator and patient consider enrollment into the study appropriate
    - FVC ≥ 40% and < or equal to 90% of predicted at screening
    - Stable baseline lung function as evidenced by a difference of < 10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to randomization
    - DLco > or equal to 25% of predicted at screening
    - Adequate hematopoietic capacity, defined as the following:
    - Hemoglobin > 8.5 g/dL
    - ANC > or equal to 1000/microlitre
    - Platelet count > or equal to 75,000/microlitre
    - Adequate liver function, defined as the following:
    - AST and ALT < or equal to 3 times the upper limit of normal (ULN)
    - Total bilirubin < or equal to 1.5 x ULN or < 3 x ULN for patients with documented Gilbert syndrome
    - Women of childbearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method as directed by their physician during treatment for 7 months after completion of study treatment (or as per local requirement)
    - Male patients must agree to remain abstinent or use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with vismodegib/placebo, and for 2 months after completion of study treatment.
    - Agreement not to donate blood or blood products during the study and for at least 7 months (or as per local requirements) after the last dose of study treatment
    E.4Principal exclusion criteria
    - Prior treatment with vismodegib or any Hh pathway inhibitor
    - Evidence of other known causes of ILD
    - Hospitalization due to an exacerbation of IPF within 4 weeks prior to, or during, screening
    - Lung transplant expected within 12 months of screening
    - Evidence of clinically significant lung disease other than IPF
    - Substantial emphysema on HRCT with degree of emphysema greater than fibrosis
    - 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 HIV infection
    E.5 End points
    E.5.1Primary end point(s)
    - Change in pulmonary function (FVC% predicted)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - from baseline to week 52
    E.5.2Secondary end point(s)
    1. Change in DLco % predicted
    2. Annualized rate of change in FVC (liters)
    3. Progression free survival
    4. Acute IPF exacerbations
    5. Change in IPF-specific health-related quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. from baseline to week 52
    2. from baseline to week 52
    3. from randomization to the first occurrence of any of the following:
    • Death from any cause
    • Non-elective hospitalization from any cause
    • ≥10% decline in FVC (L) (relative change) from baseline
    4. from randomization to first event
    5. from baseline to week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Chile
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 129
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor will offer post-trial access to the study drug vismodegib free of charge to eligible patients if all of the
    following conditions are met:
    • The patient has a life-threatening or severe medical condition and requires
    continued study drug treatment for his or her well-being
    • There are no appropriate alternative treatments available to the patient
    • The patient and his or her doctor comply with and satisfy any applicable legal or
    regulatory requirements
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-07-17
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