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    Summary
    EudraCT Number:2015-003715-38
    Sponsor's Protocol Code Number:D4190C00006
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-27
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2015-003715-38
    A.3Full title of the trial
    A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination with Tremelimumab in Subjects with Advanced Non-small Cell Lung Cancer
    Étude de phase 1b en ouvert visant à évaluer l’innocuité et la tolérabilité de MEDI4736 en association avec tremelimumab chez les patients atteints d’un cancer avancé du poumon non à petites cellules
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in patients with Non-small Cell Lung Cancer that have not responded to previous treatment, to investigate the safety, tolerability, and clinical activity of the investigational drugs MEDI4736 (durvalumab) and tremelimumab. The study will look at the effect of these drugs given either as a single agent (MEDI4736 monotherapy) or as combination therapy (MEDI4736 given together with tremelimumab ).
    Étude clinique chez des patients atteints d’un cancer du poumon non à petites cellules n’ayant pas répondu à un traitement antérieur, visant à évaluer la sécurité, la tolérance et l’activité clinique des médicaments expérimentaux MEDI4736 (durvalumab) et tremelimumab. L’étude s’intéressera aux effets de ces médicaments administrés soit comme agent simple (monothérapie de MEDI4736), soit comme thérapie associée (MEDI4736 administré avec le tremelimumab).
    A.4.1Sponsor's protocol code numberD4190C00006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02000947
    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 SponsorMedImmune LLC
    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 supportMedImmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune LLC
    B.5.2Functional name of contact pointAstraZeneca Study Info. Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1877240 9479
    B.5.6E-mailinformation.center@astrazeneca.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 namedurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form 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 INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameImmunoglobulin G1, anti-human CD antigen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nametremelimumab
    D.3.2Product code MEDI1123
    D.3.4Pharmaceutical form 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 INNTremelimumab
    D.3.9.1CAS number 745013-59-6
    D.3.9.2Current sponsor codeMEDI1123
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced or metastatic squamous or nonsquamous non- small cell lung cancer (NSCLC)
    E.1.1.1Medical condition in easily understood language
    NSCLC is a common type of lung cancer and can be defined as squamous or non-squamous, depending on the type of cells involved. Locally advanced or metastatic is cancer starting to spread.
    Le CPNPC est un type de cancer pulmonaire fréquent, qui peut être défini comme épidermoïde ou non épidermoïde, en fonction du type de cellules impliquées. Un cancer localement avancé ou
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    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
    Expansion Phase:
    Cohort B (sequential administration): determine antitumor activity of MEDI4736 in combination with tremelimumab in subjects who have received 1 prior line of treatment who are immunotherapy naïve, with non-EGFR mutation +ve/non-ALK rearrangement +ve, PD-L1-negative advanced non-squamous NSCLC
    Cohort C: determine the safety profile of MEDI4736/ tremelimumab combination at the recommended dose, using the Q4W dosing schedule in subjects with NSCLC who have received up to 3 prior lines of systemic therapy and failed PD-1/PD-L1 monotherapy
    Cohort C: determine antitumor activity of MEDI4736 in combination with tremelimumab at the recommended dose using Q4W dosing schedule in subjects with advanced NSCLC who have received up to 3 prior lines of systemic therapy and failed PD-1/PD-L1 monotherapy.
    Dose-expansion Cohorts: evaluate the safety profile of MEDI4736 monotherapy in subjects who have experienced irAEs after discontinuing MEDI4736 in combination with tremelimumab
    Phase d’extension
    Coh B (admin séq): Déterm l’activité antitumo de MEDI4736 associé au Treme chez des patients atteints de CPNPC non épiderm avancé ayant reçu 1 ligne de traitem antér., naïfs d’immunothérapie non positifs à une mutation de l’EGFR/non positifs à un réarrangement du gène ALK, PD-L1-nég
    Coh C: Déterm le profil d’innocuité de MEDI4736/Treme à la dose recommandée en utilisant le schéma posol Q4S chez des patients atteints de CPNPC ayant reçu jusqu’à 3 lignes de traitem systémique antér. et en échec après une monothérapie PD-1/PD-L1
    Coh C: Déterminer l’activité antitumo du MEDI4736 associé au Treme à la dose recommandée en utilisant le schéma posologique Q4S chez des patients atteints de CPNPC avancé ayant reçu jusqu’à 3 lignes de traitement systémique antér. et en échec après une monothérapie PD-1/PD-L1
    Coh d'extension de dose: Évaluer le profil d’innocuité d’une monothérapie de MEDI4736 chez des patients ayant présenté des EIs après l'arrêt du MEDI4736 associé au Treme
    E.2.2Secondary objectives of the trial
    Cohort B (sequential admin):
    •Evaluate antitumor activity of the MEDI4736/tremelimumab recommended dose combination (Q4W schedule) in subjects with 1 prior line of treatment, non-EGFR mutation +ve/non-ALK rearrangement +ve advanced non-squamous NSCLC regardless of PD-L1 status
    •Determine the safety profile of the MEDI4736/tremelimumab combination in non-squamous NSCLC subjects
    •Evaluate candidate, predictive, and/or prognostic biomarkers in immunotherapy-naïve, non-EGFR mutation +ve/non-ALK rearrangement +ve, advanced non-squamous NSCLC subjects for correlation with MEDI4736/tremelimumab combination activity
    Cohort C: Evaluate antitumor activity of the MEDI4736/tremelimumab combination in advanced NSCLC subjects who failed PD-1/PD-L1 monotherapy
    PK of:
    •MEDI4736 in combination with tremelimumab
    •tremelimumab in combination with MEDI4736
    Determine the immunogenicity of MEDI4736 in combination with Tremelimumab and of tremelimumab in combination with MEDI473
    Coh B (adm. séq) :
    •Évaluer l’act. antitumo de l’asso. à la dose recomm. de MEDI4736/Treme (schéma Q4S) chez des patients atteints de CPNPC avancé non épidermoïde ayant reçu une ligne de traitem. antér. non positifs à une mutation de l’EGFR/non positifs à un réarrangement du gène ALK, indépendam. du statut PD-L1
    •Déterm. le profil d’innoc. de l’asso MEDI4736/Treme chez les patients atteints de CPNPC non épiderm.
    •Évaluer les biom. candidats prédictifs et/ou pronostiques chez les patients atteints de CPNPC non épiderm. naïfs d’immunothérapie non positifs à une mutation de l’EGFR/non positifs à un réarrangement du gène ALK pour établir une corrélation avec l’activité de l’asso MEDI4736/Treme
    Coh C: Évaluer l’activité antitumorale de l’asso MEDI4736/Treme chez les patients atteints de CPNPC avancé en échec après une monothér. PD-1/PD-L1 PK de :
    •MEDI4736 en asso avec Treme
    •Treme en asso avec MEDI4736
    Déterm. l’immunogénicité de MEDI4736 asso. au Treme et de Treme asso. au MEDI473
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Histologically confirmed locally advanced or metastatic squamous or nonsquamous NSCLC
    3. ECOG performance status of 0 or 1
    4. At least 1 measurable lesion according to RECIST Version 1.1
    5. At least 1 lesion amenable to biopsy at screening
    6. Adequate organ and marrow function
    1. ≥ 18 ans
    2.CPNPC épidermoïde ou non épidermoïde localement avancé ou métastasique confirmé par histologie
    3.Score de performance ECOG de 0 ou 1
    4.Au moins 1 lésion mesurable selon les critères RECIST Version 1.1
    5.Au moins 1 lésion accessible à la biopsie à la sélection
    6.Fonction organique et médullaire adéquate
    E.4Principal exclusion criteria
    1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
    2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug
    3. Active or prior documented autoimmune disease within the last 2 years
    4. Major surgical procedure within 28 days prior to the first dose of study drug
    1. Toute chimiothérapie, immunothérapie, biothérapie ou hormonothérapie simultanée pour un traitement du cance
    2.Utilisation passée ou actuelle d’un immunosuppresseur dans les 14 jours précédant la première dose du médicament de l’étude
    3.Maladie auto-immune active ou antérieure documentée dans les 2 dernières années
    4.Intervention chirurgicale lourde dans les 28 jours précédant la première dose du médicament de l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Cohort C: The endpoints for safety will include adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results.

    Cohort B (sequential administration) and Cohort C: Objective response (OR) based on RECIST Version 1.1
    Cohorte C : Les critères d’innocuité comprendront les événements indésirables (EI), les événements indésirables graves (EIG), les évaluations de laboratoire, les signes vitaux, les examens cliniques et les résultats d’électrocardiogramme (ECG).

    Cohorte B (administration séquentielle) et Cohorte C : Réponse objective (RO) basée sur les critères RECIST Version 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohort C: Safety Evaluations take place at Screening, Cycle 1 (Days 1,2, 8, 15 and 22) then Day 1 and Day 22 of each cycle through Cycle 13. ECG testing takes place at Screening, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 13 Day 1

    Cohort B: Objective response as determined by radiographic disease assessment per RECIST Version 1.1 at Screening and every 8 weeks thereafter as per protocol
    Cohorte C : Les évaluations d’innocuité ont lieu à la Sélection, pendant le Cycle 1 (Jours 1, 2, 8, 15 et 22), puis le Jour 1 et le Jour 22 de chaque cycle jusqu’au Cycle 13. Les examens d’ECG ont lieu à la Sélection, au Jour 1 du Cycle 3, au Jour 1 du Cycle 4, au Jour 1 du Cycle 7 et au Jour 1 du Cycle 13

    Cohorte B : Réponse objective telle que déterminée par évaluation radiographique de la maladie conformément aux critères RECIST Version 1.1 à la Sélection et toutes les 8 semaines par la suite conformément au protocole
    E.5.2Secondary end point(s)
    The endpoints for assessment of antitumor activity include:
    ◦ Dose-expansion Cohort B (sequential administration) and Cohort C:
    - OR as determined by the investigator based on RECIST v1.1.
    - Duration of response (DoR), disease control (DC), and progression-free survival (PFS) based on
    RECIST v1.1 by investigator and BICR, and overall survival (OS).
    • Dose-expansion Cohort B (sequential administration)
    ◦ The endpoints for safety will include AEs, SAEs, laboratory evaluations, vital signs, physical
    examinations, and electrocardiogram (ECG) results.
    • The endpoints related to candidate predictive and/or prognostic biomarkers in dose-expansion Cohort B (sequential administration) are likely to focus on tissue-based, protein or gene expression measures and peripheral gene signatures including, but not limited to:
    ◦ PD-L1 expression / localization on tumor membrane and tumor-infiltrating immune cells within the
    tumor microenvironment
    ◦ IHC measures of markers associated with infiltrating immune cells (eg, Cluster of Differentiation 8)
    ◦ Gene expression signatures associated with adaptive response (eg, IFNGamma and related genes)
    • The endpoints for assessment of PK of MEDI4736 and tremelimumab include individual MEDI4736 and tremelimumab concentrations in serum and PK parameters including CmaxAUC), clearance, and half-life (t½).
    • The endpoints for assessment of immunogenicity of MEDI4736 and tremelimumab include the number and percentage of subjects who develop detectable ADAs.
    Les critères d’évaluation de l’activité antitumorale comprennent :
    ◦Cohorte B (administration séquentielle) et Cohorte C de l’extension de dose :
    -RO telle que déterminée par l’investigateur d’après les critères RECIST v1.1.
    Durée de la réponse (DdR), contrôle de la maladie (CM) et survie sans progression (SSP) d’après les critères RECIST v1.1 selon l’investigateur et le CCIA, et survie globale (SG).
    •Cohorte B (administration séquentielle) de l’extension de dose
    Les critères d’innocuité comprendront les EI, les EIG, les évaluations de laboratoire, les signes vitaux, les examens cliniques et les résultats d’électrocardiogramme (ECG).
    •Les critères relatifs aux biomarqueurs candidats prédictifs et/ou pronostiques dans la Cohorte B de l’extension de dose (administration séquentielle) devraient se focaliser sur des mesures d’expression des protéines ou des gènes sur les tissus et des signatures de gènes périphériques dont, entre autres :
    Expression / localisation de PD-L1 sur la membrane tumorale et les cellules immunitaires infiltrant les tumeurs au sein du microenvironnement tumoral
    ◦Mesures par IHC des marqueurs associés aux cellules immunitaires infiltrantes (par exemple, CD8, cluster of Differentiation 8)
    ◦Signatures de l’expression génique associée à une réponse adaptative (par exemple, IFNGamma et gènes liés)
    •Les critères d’évaluation de la PK de MEDI4736 et de tremelimumab comprennent les concentrations sériques individuelles de MEDI4736 et de tremelimumab et les paramètres PK dont Cmax, AUC, clairance et demi-vie (t½).
    •Les critères d’évaluation de l’immunogénicité de MEDI4736 et de tremelimumab comprennent le nombre et le pourcentage de patients qui développent des AAM décelables.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening through 5 years after the last subject receives the first dose of study medication
    De la Sélection jusqu’à 5 ans après que le denier patient aura reçu la première dose du médicament de l’étude
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Canada
    France
    Germany
    Italy
    Korea, Republic of
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    As per protocol: The end of the study (“study completion”) is defined as 5 years after the last subject begins treatment or the date the study is closed by the sponsor, whichever occurs first.
    Conformément au protocole : La fin de l’étude (« achèvement de l’étude ») se définit comme 5 ans après que le dernier patient commence le traitement, ou la date à laquelle l’étude est clôturée par le promoteur,
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 418
    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)
    None
    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 Decision2016-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-17
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