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    Summary
    EudraCT Number:2014-005614-29
    Sponsor's Protocol Code Number:CC-486-NSCL-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-005614-29
    A.3Full title of the trial
    A Phase 2 multicenter, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 (oral azacitidine) in combination with pembrolizumab (MK-3475) versus pembrolizumab plus placebo in subjects with previously treated locally advanced or metastatic non-small cell lung cancer
    Estudio de fase 2 multicéntrico, aleatorizado, controlado con placebo y doble ciego para evaluar la seguridad y la eficacia de CC 486 (azacitidina oral) en combinación con pembrolizumab (MK 3475) frente a pembrolizumab más placebo en sujetos con cáncer de pulmón no microcítico, localmente avanzado o metastásico, tratado previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate if CC-486 plus pembrolizumab works and is safe in patients with advanced or metastatic non-small cell lung cancer who have previously received platinum containing treatment.
    Un ensayo clínico para evaluar si CC-486 más pembrolizumab funciona y es seguro en pacientes con cáncer de pulmón no microcítico avanzado o metastásico que han recibido previamente tratamiento que contiene platino
    A.4.1Sponsor's protocol code numberCC-486-NSCL-001
    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 SponsorCelgene Corporation
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+3491422 90 00
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    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.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 nameOral Azacitidine
    D.3.2Product code CC-486
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form Lyophilisate 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 INNPEMBROLIZUMAB
    D.3.9.2Current sponsor codePEMBROLIZUMAB
    D.3.9.3Other descriptive namePEMBROLIZUMAB
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Second-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
    Segunda linea de tratamiento en cáncer de pulmón no microcítico localmente avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic non-small cell lung cancer (NSCLC) that has previously been treated with platinum containing regimen.
    Cancer de pulmón no microcítico avanzado o metastásico que ha sido tratado previamente con un régimen que contiene platino
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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 18.0
    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 18.0
    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 18.0
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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 18.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the efficacy of CC-486 plus pembrolizumab versus pembrolizumab plus placebo based on PFS as measured using RECIST 1.1 criteria
    Evaluar la eficacia de CC 486 más pembrolizumab frente a pembrolizumab más placebo en función de la supervivencia libre de progresión (SLP) determinada mediante los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1.
    E.2.2Secondary objectives of the trial
    -To estimate DCR of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    -To estimate OS of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    -To estimate ORR of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    -To evaluate safety and tolerability of CC-486 plus pembrolizumab versus pembrolizumab plus placebo
    ?To evaluate the impact of pembrolizumab on the pharmacokinetics of CC-486
    -Determinar la tasa de control de la enfermedad (TCE) con CC 486 más pembrolizumab frente a pembrolizumab más placebo.
    -Determinar la supervivencia global (SG) con CC 486 más pembrolizumab frente a pembrolizumab más placebo.
    -Determinar la tasa de respuesta global (TRG) con CC 486 más pembrolizumab frente a pembrolizumab más placebo.
    -Evaluar la seguridad y la tolerabilidad de CC 486 más pembrolizumab frente a pembrolizumab más placebo.
    -Evaluar los efectos de pembrolizumab sobre la farmacocinética de CC 486.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Subject is >= 18 years of age at the time of signing the informed consent form.
    -Subject has histologically or cytologically confirmed squamous or non-squamous NSCLC.
    -Subject has stage IIIB or IV NSCLC and was pretreated with 1 prior systemic platinum based chemotherapy.
    -Subject has provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status.
    -Subject has radiographically-documented measurable disease, as per RECIST 1.1.
    -Subject has an ECOG performance status of 0 to 1.
    -Subject has adequate organ and bone marrow functions
    -Edad mínima de 18 años en el momento de firmar el documento de consentimiento informado.
    -CPNM epidermoide o no epidermoide confirmado histológica o citológicamente.
    -CPNM en estadio IIIB o IV y tratamiento previo con una pauta de quimioterapia sistémica a base de platino.
    -Donación por parte del sujeto de una muestra de tejido tumoral fijado en formol obtenida a partir de una biopsia de una lesión tumoral en el momento o después de establecer el diagnóstico de enfermedad metastásica Y a partir de un foco no irradiado previamente para evaluar el estado de PD L1.
    -Enfermedad mensurable documentada radiológicamente, de acuerdo con los criterios RECIST 1.1.
    -Estado funcional del ECOG de 0 o 1.
    -Funciones orgánicas y función medular adecuadas
    E.4Principal exclusion criteria
    -Subject has known sensitizing EGFR and/or positive ALK mutation
    -Subject has received prior therapy with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanism
    -Subject has had radiotherapy <=4 weeks or limited field radiation for palliation <= 2 weeks prior to starting IP, and/or from whom >= 30% of the bone marrow was irradiated.
    -Subject has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
    -Subject has active autoimmune disease that has required systemic treatment within the past 2 years
    -Subject with uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
    -Presencia de una mutación en ALK o EGFR sensibilizadora
    -Tratamiento previo con otro fármaco anti PD 1, PD L1 o PD L2 o un anticuerpo dirigido contra otros receptores o mecanismos inmunorreguladores
    -Recepción de radioterapia en las 4 semanas o de radioterapia de campo limitado con fines paliativos en las 2 semanas previas al comienzo de la administración del PEI o en las que se irradió al menos el 30% de la médula ósea
    -Recepción de una vacuna de virus vivos en los 30 días previos al comienzo previsto del tratamiento. Se permitirán las vacunas contra la gripe estacional que no contengan virus
    -Presencia de una enfermedad autoinmunitaria activa que ha precisado tratamiento sistémico en los 2 últimos años
    -Metástasis en el sistema nervioso central (SNC) no controladas o sintomáticas o meningitis carcinomatosa
    E.5 End points
    E.5.1Primary end point(s)
    PFS measured as time from randomization to progression according to RECIST 1.1 (based on Investigator assessment)
    SLP medida como el tiempo transcurrido entre la aleatorización y la progresión conforme a los criterios RECIST 1.1 (según la evaluación del investigador).
    E.5.1.1Timepoint(s) of evaluation of this end point
    When 70 PFS events occur
    cuando se hayan producido 70 episodios de SLP
    E.5.2Secondary end point(s)
    1.Number (%) of subjects with SD for >= 18 weeks, complete response (CR) or PR (DCR).
    2.Overall survival.
    3.Number (%) of subjects who achieve an objective CR or PR (ORR).
    4.Safety to include the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, Grade 3-4 TEAEs, TEAEs of special interest, and laboratory abnormalities and other safety parameters.
    5.Plasma PK parameters such as maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), terminal half-life (t1/2), apparent total body clearance (CL/F) and apparent volume of distribution (Vz/F) for CC-486.
    1. Número (%) de sujetos con EE durante >= 18 semanas, respuesta completa (RC) o RP (TCE).
    2. Supervivencia global
    3. Número (%) de sujetos que logren una RC o RP objetiva (TRG).
    4. Seguridad, determinada mediante la incidencia de acontecimientos adversos aparecidos durante el tratamiento (AAAT), AAAT graves, AAAT de grado 3 4, AAAT de especial interés y anomalías analíticas y otros parámetros de seguridad.
    5. Parámetros FC en plasma, como concentración observada máxima (Cmáx), área bajo la curva de concentración tiempo (AUC), tiempo hasta la concentración máxima (Tmáx), semivida terminal (t1/2), aclaramiento corporal total aparente (CL/F) y volumen de distribución aparente (Vz/F) de CC 486.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Every 6 weeks from randomization for the first 24 weeks then every 9 weeks until disease progression or start of a new anticancer treatment, or withdrawal of consent
    2.When 70 deaths occur
    3.Every 6 weeks from randomization for the first 24 weeks then every 9 weeks until disease progression or start of a new anticancer treatment, or withdrawal of consent
    4.Continuous after informed consent signature
    5.Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
    1. : cada 6 semanas a partir de la aleatorización durante las 24 primeras semanas y luego cada 9 semanas hasta que se produzca progresión de la enfermedad ,comienzo de un nuevo tratamiento antineoplásico o retirada del consentimiento
    2. cuando se produzcan 70 muertes
    3. cada 6 semanas a partir de la aleatorización durante las 24 primeras semanas y luego cada 9 semanas hasta que se produzca progresión de la enfermedad ,comienzo de un nuevo tratamiento antineoplásico o retirada del consentimiento
    4. De forma ininterrumpida tras la firma del consentimiento informado
    5. Antes de la dosis; 0,25; 0,5; 1; 1,5; 2; 2,5; 3; 3,5; 4; 6 y 8 horas de la administración
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    France
    Germany
    Greece
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    El final del ensayo se define como la fecha de la última visita del último sujeto que finalice el seguimiento posterior al tratamiento o la fecha de recepción de los últimos datos correspondientes al último sujeto que sean necesarios para los análisis principales, secundarios o exploratorios, tal como se establece en el protocolo, la que sea posterior.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-09-11. Yes
    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 47
    F.4.2.2In the whole clinical trial 90
    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)
    Treatment or care after participation in the trial will be at the investigator's discretion.
    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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
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