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    Summary
    EudraCT Number:2014-003356-30
    Sponsor's Protocol Code Number:M18-007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-01-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003356-30
    A.3Full title of the trial
    A 3-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo versus Carboplatin, Pemetrexed plus 1 or 2 Truncated Courses of Demcizumab in Subjects with Non-Squamous Non-Small Cell Lung Cancer
    Studio a 3 bracci, di fase 2, randomizzato in doppio cieco con Carboplatino, Pemetrexed più placebo verso Carboplatino, Pemetrexed più 1 o 2 serie di cicli interrotti di Demcizumab, in soggetti affetti da carcinoma polmonare non a piccole cellule, non squamoso
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of two different treatment plans of demcizumab or placebo in combination with standard chemotherapy in non-squamous non-small cell lung cancer
    Studio di due diversi piani di trattamento con demcizumab o placebo in combinazione con la chemioterapia standard nel carcinoma polmonare non a piccole cellule, non squamoso
    A.3.2Name or abbreviated title of the trial where available
    DENALI
    DENALI
    A.4.1Sponsor's protocol code numberM18-007
    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 SponsorOncoMed Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportOncoMed Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoMed Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointVP, Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address800 Chesapeake Drive
    B.5.3.2Town/ cityRedwood City, CA
    B.5.3.3Post code94063
    B.5.3.4CountryUnited States
    B.5.4Telephone number16505566933
    B.5.5Fax number16502988600
    B.5.6E-mailrainer.brachmann@oncomed.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 No
    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.3.1Product namedemcizumab
    D.3.2Product code OMP-21M18
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDemcizumab
    D.3.9.2Current sponsor codeOMP-21M18
    D.3.9.4EV Substance CodeSUB32400
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 2
    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 Carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameCarboplatin
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarboplatin
    D.3.9.3Other descriptive namecarboplatin
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 3
    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 Alimta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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.3.1Product nameAlimta
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMETREXED
    D.3.9.1CAS number 137281-23-3
    D.3.9.4EV Substance CodeSUB09655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Squamous Non-Small Cell Lung Cancer
    carcinoma polmonare non a piccole cellule, non squamoso
    E.1.1.1Medical condition in easily understood language
    Lung cancer of the non-squamous and non-small cell type that cannot come from the cells that line the inner airways of the lungs or be of the type with very small cancer cells

    Carcinoma polmonare di tipo non squamoso non a piccolecellule che non può provenire dalle cellule che rivestono le vie aereeinterne dei polmoni oessere caratterizzato da cellule tumorali molto piccole
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    Confrontare l'efficacia tra il Braccio 1 e il Braccio 2 e tra il Braccio 1 e il Braccio 3 in soggetti affetti da carcinoma polmonare non a piccole cellule (NSCLC), non squamoso, di stadio IV in prima linea
    E.2.2Secondary objectives of the trial
    • To compare the safety of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To compare the rate of immunogenicity of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To determine population pharmacokinetics of demcizumab when combined with carboplatin and pemetrexed in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • Confrontare la sicurezza tra il Braccio 1 e il Braccio 2 e tra il Braccio 1 e il Braccio 3 in soggetti affetti da NSCLC, non squamoso, di stadio IV in prima linea
    • Confrontare il tasso di immunogenicità tra il Braccio 1 e il Braccio 2 e tra il Braccio 1 e il Braccio 3 in soggetti affetti da NSCLC, non squamoso, di stadio IV in prima linea
    • Determinare la farmacocinetica di popolazione con demcizumab in
    combinazione con carboplatino e pemetrexed, in soggetti affetti da NSCLC, non squamoso, di stadio IV in prima linea
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent Form
    2. Histologically or cytologically confirmed Stage IV non-squamous non-small cell lung cancer
    3. Availability of FFPE tumor tissue, either fresh core-needle-biopsied or archived
    4. Age >21 years
    5. ECOG performance status of 0 or 1
    6. Disease that is measurable per RECIST v1.1
    7. Adequate organ and marrow function
    8. For women of childbearing potential, agreement to use two effective forms of contraception
    1. Modulo di consenso informato firmato
    2. NSCLC non squamoso di stadio IV confermato istologicamente o
    citologicamente
    3. Disponibilità di tessuto tumorale FFPE, ottenuto da agobiopsia recente o d’archivio
    4. Età 21 anni
    5. Stato di performance ECOG pari a 0 o 1 (vedere Appendice B)
    6. Malattia misurabile in base a RECIST v1.1 (Appendice C)
    7. Adeguata funzionalità organica e midollare
    8. Per le donne in età fertile, consenso all'uso di due forme efficaci di
    contraccezione
    E.4Principal exclusion criteria
    1. Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
    2. NSCLC with EGFR mutation or anaplastic lymphoma kinase (ALK) gene translocation (such as EML4-ALK)
    3. Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) for the treatment of Stage IV non-squamous non-small cell lung cancer
    4. Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) or tracheo-esophageal fistula
    5. Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
    6. Metastases involving the lumen of the gastrointestinal tract
    7. Malignancies other than non-squamous non-small cell lung cancer successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers)
    8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
    9. Significant intercurrent illness defined as an illness that may result in the subject’s death prior to their death from non-squamous non-small cell lung cancer and/or significantly limit their ability to comply with the requirements of this study
    10. Recent hemoptysis >2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
    11. History of cerebral vascular accident (CVA) or transient ischemic attacks (TIAs) within 6 months of randomization
    12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study
    13. Blood pressure (BP) of >140/90 mmH
    14. History, signs or symptoms indicative of an increased cardiac risk, including, but not limited to BNP value of >100 pg/mL, left ventricular ejection fraction (LVEF) <50%, peak tricuspid velocity >3.0 m/s on Doppler echocardiogram, history of or current cardiac ischemia or congestive heart failure
    1. Tumori istologicamente o citologicamente documentati, avanzati, misti non a piccole cellule e a piccole cellule o carcinomi misti adenosquamosi
    2. NSCLC con mutazione di EGFR o traslocazione del gene della chinasi del linfoma anaplastico (ALK) (ad esempio EML4-ALK)
    3. Terapia precedente o in corso (compresa chemioterapia, terapia con anticorpi, inibitori della tirosin-chinasi, radioterapia, immunoterapia, terapia ormonale o terapia sperimentale) per il trattamento del NSCLC non squamoso di Stadio IV
    4. Evidenza della diffusione del tumore nei grandi vasi sanguigni,
    cavitazione di una o più masse tumorali del polmone o fistola tracheo-esofagea
    5. Metastasi cerebrali, malattia leptomeningea, epilessia incontrollata o malattia neurologica attiva
    6. Metastasi che coinvolgono il lume del tratto gastrointestinale
    7. Neoplasie maligne diverse dal NSCLC non squamoso, trattate con esito positivo nei 3 anni precedenti la randomizzazione (ad eccezione di
    determinati tumori in fase iniziale)
    8. Anamnesi di reazione allergica significativa attribuita a terapia con
    anticorpi monoclonali umanizzati o umani
    9. Malattia significativa intercorrente, definita come una malattia che può portare al decesso dei soggetti prima del loro decesso per NSCLC non squamoso e/o può limitare significativamente la loro capacità di rispettare i requisiti di questo studio
    10. Emottisi recente >2,5 ml o sanguinamento grave da un'altra parte,
    disturbo emorragico o coagulopatia noti o terapia anticoagulante
    11. Anamnesi di accidente cerebrovascolare (CVA) o attacchi ischemici
    transitori (TIA) entro 6 mesi dalla randomizzazione
    12. Intervento chirurgico importante, biopsia aperta o lesione traumatica significativa nei 28 giorni precedenti la randomizzazione o previsione di intervento chirurgico importante durante lo studio
    13. Pressione sanguigna (BP) di >140/90 mmH
    14. Anamnesi, segni o sintomi indicativi di un aumento del rischio cardiaco, compresi a titolo esemplificativo valori di BNP >100 pg/mL, frazione di eiezione ventricolare sinistra (LVEF) <50%, velocità del picco della tricuspide >3,0 m/s su ecocardiogramma doppler, anamnesi di ischemia cardiaca attuale o insufficienza cardiaca congestizia
    E.5 End points
    E.5.1Primary end point(s)
    To compare the Investigator-assessed median progression-free survival as assessed by RECIST v1.1 in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non squamous non-small cell lung cancer
    Confrontare la sopravvivenza libera da progressione mediana valutata dallo Sperimentatore secondo la valutazione RECIST v1.1 tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3 in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    E.5.1.1Timepoint(s) of evaluation of this end point
    At scheduled visits.
    Alle visite programmate
    E.5.2Secondary end point(s)
    • To compare the Investigator-assessed RECIST v1.1 response rate in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To compare the Investigator-assessed RECIST v1.1 clinical benefit rate (i.e., the rate of complete response + partial response + stable disease) in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To compare the Investigator-assessed progression-free survival at 6 months in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To compare the median survival in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To compare the Independent-Review-Facility-assessed RECIST v1.1 response rate and progression-free survival based solely on radiographs in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To determine the half-life, volume of distribution and clearance of demcizumab when combined with carboplatin and pemetrexed in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To compare the safety profile through adverse events, monitoring, physical examination, vital signs, and clinical laboratory testing as outlined in the Schedule of Assessments between Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer
    • To compare the incidence of anti-demcizumab antibody development and neutralizing antibody development in subjects with 1st-line stage IV non-squamous non-small cell lung cancer in Arm 1 to Arm 2 and Arm 1 to Arm 3
    • Confrontare il tasso di riposta secondo RECIST v1.1 valutato dallo
    Sperimentatore tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3 in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    • Confrontare il tasso di beneficio clinico secondo RECIST v1.1 valutato dallo Sperimentatore (ovvero, il tasso di risposta completa + risposta parziale + malattia stabile) tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3 in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    • Confrontare la sopravvivenza libera da progressione valutata dallo
    Sperimentatore a 6 mesi tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3 in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    • Confrontare la sopravvivenza mediana tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3 in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    • Confrontare il tasso di risposta e la sopravvivenza libera da progressione secondo RECIST v1.1 valutato da un Organo indipendente di revisione solo sulla base delle radiografie tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3 in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    • Determinare l’emivita, il volume di distribuzione e la clearance di
    demcizumab quando viene combinato con carboplatino e emetrexed in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    • Confrontare il profilo di sicurezza attraverso eventi avversi, monitoraggio, esame obiettivo, funzioni vitali ed esami clinici di laboratorio come indicato nel Programma delle valutazioni tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3 in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea
    • Confrontare l’incidenza dello sviluppo di anticorpi anti-demcizumab e dello sviluppo di anticorpi neutralizzanti in soggetti con carcinoma polmonare non a piccole cellule non squamoso di stadio IV in prima linea tra il braccio 1 e il braccio 2 e tra il braccio 1 e il braccio 3
    E.5.2.1Timepoint(s) of evaluation of this end point
    At scheduled visits.
    Alle visite programmate.
    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 Yes
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicità
    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 trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Belgium
    France
    Italy
    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
    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 months6
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 201
    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 patients will revert to the expected normal treatment of the condition
    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 Decision2015-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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