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    Summary
    EudraCT Number:2010-022949-17
    Sponsor's Protocol Code Number:ET-D-009-10
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-06
    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 number2010-022949-17
    A.3Full title of the trial
    Phase III international, randomized study of Trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer
    progressing within 6-12 months of last platinum
    Ensayo fase III, internacional y aleatorizado de trabectedina más doxorrubicina liposomal pegilada (DLP) en comparación con carboplatino más DLP en pacientes con cáncer de ovario que presentan progresión en los 6-12 meses siguientes al último tratamiento con platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to determine if the combination of trabectedin and PLD is better at improving overall survival over carboplatin and PLD in subjects with advanced ovarian cancer relapsed between 6 and 12 months from the end of a last platinum-based chemotherapy.
    Se trata de un ensayo en fase III para determinar si la combinación de trabectedina y DLP mejora la supervivencia frente a carboplatino y DLP en pacientes con cáncer de ovario avanzado entre 6 y 12 meses después del último tratamiento de quimioterapia a base de platino
    A.3.2Name or abbreviated title of the trial where available
    INOVATYON
    A.4.1Sponsor's protocol code numberET-D-009-10
    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 SponsorMario Negri Gynecologic Oncology Group
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharmaMar, S.A. Sociedad Unipersonal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressVia La Masa, 19
    B.5.3.2Town/ cityMilan
    B.5.3.3Post codeI - 20156
    B.5.3.4CountryItaly
    B.5.4Telephone number3902390 141
    B.5.5Fax number3902354 6277
    B.5.6E-mailmnegri@marionegri.it
    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 Yondelis 1 mg powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderPharmaMar S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/171
    D.3 Description of the IMP
    D.3.1Product nameTrabectedin
    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 INNTrabectedin
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    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 RoleComparator
    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 Caelyx 2 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSP Europe
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePegylated Liposomal Doxorubicin
    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 INNDoxorubicin Hydrochloride
    D.3.9.1CAS number 25316-40-9
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ovarian cancer
    Cancer de ovario
    E.1.1.1Medical condition in easily understood language
    Cancer of the ovaries
    Cancer de ovarios
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10033130
    E.1.2Term Ovarian cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the combination of trabectedin (Yondelis®) and pegylated liposomal doxorubicin (PLD) prolongs overall
    survival (OS) over carboplatin and PLD in patients with relapsed ovarian cancer progressing within 6-12 months after end of last platinum.
    Demostrar que la combinación de trabectedina (Yondelis®) y doxorrubicina liposomal pegilada (DLP) prolonga la supervivencia global (SG) con respecto a carboplatino y DLP en pacientes con cáncer de ovario recidivante que presentan progresión en los 6-12 meses siguientes al final del último tratamiento con platino.
    E.2.2Secondary objectives of the trial
    - To evaluate the time from randomization to subsequent chemotherapy and the overall survival counted from the administration of subsequent chemotherapy.
    - To evaluate serological response of CA-125 in each arm.
    - To compare the quality of life (QoL) in each arm using the European Organization for Research and Treatment of Cancer
    (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30) and the Quality of Life Questionnaire-OV28 (QLQ-OV28).
    - To compare safety profile, progression free survival (PFS), objective response rate (ORR), the type and length of remission (response rate and PFS) after subsequent therapies following each of the two combinations.
    ? Evaluar el tiempo transcurrido entre la aleatorización y la administración de la quimioterapia posterior, y la supervivencia global calculada desde la quimioterapia posterior.
    ? Evaluar la respuesta serológica de CA-125 en cada grupo.
    ? Comparar la calidad de vida (CdV) en cada grupo mediante los cuestionarios de calidad de vida C30 (QLQ-C30) y OV28 (QLQ-OV28) de la Organización europea para la investigación y el tratamiento del cáncer (EORTC).
    ? Comparar el perfil de seguridad, la supervivencia sin progresión (SSP), la tasa de respuestas objetivas (TRO), el tipo y la duración de la remisión (tasa de respuesta y SSP) después de los tratamientos posteriores una vez finalizadas ambas combinaciones.
    ? Subensayo en determinados centros: realizar análisis farmacocinéticos (FC) en plasma y ascitis en un subgrupo de pacientes tratadas con trabectedina y DLP.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study in selected centers: To perform pharmacokinetic (PK) analyses in both plasma and ascites in a subset of patients receiving trabectedin and PLD.
    Sub-estudio en una selección de centros: Realizar análisis de farmacocinética (FC) en muestras de plasma y ascitis en un subconjunto de pacientes que reciben trabectadina y DLP.
    E.3Principal inclusion criteria
    1. Female, aged ? 18 years
    2. Histologically and/or cytologically proven epithelial ovarian, epithelial fallopian tube cancer or primary peritoneal cancer
    3. Progression free interval between six and twelve (6-12) months (calculated from the first day of the last cycle of the last platinumbased
    chemotherapy until the date of progression confirmation through radiologic imagery). Patients may have received up to two platinum-based chemotherapy lines, of which at least one must have contained a taxane.
    4. Measurable or evaluable disease confirmed by radiological imaging, such as magnetic resonance imaging (MRI), computed tomography (CT) scan, or PET/CT scan at study entry (CA-125 rise not supportedby radiological evidence of disease is not accepted as criteria for defining progression) or histological proven recurrent ovarian cancer even in the absence of postoperatively measurable or evaluable lesions.
    5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ? 2
    6. Estimated life expectancy ? 12 weeks
    7. Patients must be accessible for treatment and follow-up.
    8. Adequate organ function within 14 days prior to first cycle as evidenced by:
    a. Peripheral blood counts and serum chemistry values:
    i. Hemoglobin ? 9 g/dl
    ii. Absolute neutrophil count (ANC) ? 1,500/?l
    iii. Platelet count ? 100,000/?l
    iv. Estimated glomerular filtration rate > 60 ml/min according to the Cockroft-Gault formula
    v. Creatine phosphokinase (CPK) ? 2.5 x ULN
    b. Hepatic function variables:
    i. Total bilirubin ? ULN
    ii. Total alkaline phosphatase ? 2.5 ULN (consider hepatic isoenzymes 5-nucleotidase if the elevation could be osseous in origin)
    iii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be ? 2.5 x ULN
    9. Patients must be able to receive dexamethasone or its equivalent, which is required if randomly assigned to treatment with trabectedin plus PLD
    10. Informed consent of the patient
    1.Mujeres ? 18 años.
    2.Cáncer epitelial de ovario, cáncer epitelial de trompa de Falopio o cáncer peritoneal primario confirmado por métodos histológicos o citológicos.
    3.Intervalo sin progresión de entre seis y doce (6-12) meses (calculado entre el primer día del último ciclo del último tratamiento con quimioterapia a base de platino y la fecha de confirmación de la progresión mediante pruebas radiológicas). Las pacientes podrán haber recibido un máximo de dos líneas de quimioterapia a base de platino, de las que al menos una tendrá que haber contenido un taxano.
    4.Enfermedad mensurable o evaluable confirmada mediante pruebas radiológicas, como resonancia magnética (RM), tomografía computarizada (TC) o PET/TC en el momento de incorporación al ensayo (la evaluación del CA-125 no respaldada por datos radiológicos de enfermedad no se acepta como criterio para definir la progresión) o cáncer de ovario recidivante confirmado histológicamente incluso en ausencia de lesiones mensurables o evaluables de forma postoperatoria.
    5.Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) ? 2.
    6.Esperanza de vida prevista ? 12 semanas.
    7.Las pacientes deben poder ser objeto de tratamiento y seguimiento.
    8.Función orgánica adecuada en los 14 días anteriores al primer ciclo, según lo puesto de manifiesto por:
    a.Recuentos celulares en sangre periférica y valores de bioquímica sérica:
    i.Hemoglobina ? 9 g/dl
    ii.Recuento absoluto de neutrófilos (RAN) ? 1.500/?l
    iii.Recuento de plaquetas ? 100.000/?l
    iv.Filtración glomerular calculada > 60 ml/min. conforme a la fórmula de Cockroft-Gault
    v.Creatina fosfocinasa (CPK) ? 2,5 veces el límite superior de la normalidad (LSN)
    b.Variables de función hepática:
    i.Bilirrubina total ?LSN
    ii.Fosfatasa alcalina total ? 2,5 veces el LSN (valorar la isoenzima hepática 5-nucleotidasa en caso de que la elevación pudiera ser de origen óseo)
    iii.Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ? 2,5 veces el LSN
    9.Las pacientes han de poder recibir dexametasona o un equivalente, requisito necesario en caso de ser asignadas al azar al tratamiento con trabectedina más DLP.
    10.Consentimiento informado de la paciente.
    E.4Principal exclusion criteria
    1. Non epithelial ovarian or mixed epithelial/non epithelial tumors (e.g., Mullerian tumors)
    2. Patients who did not respond to last platinum-based therapy or in whom last relapse occurred < 6 months or > 12 months from the last dose of platinum
    3. Bowel obstruction, sub-occlusive disease or the presence of symptomatic brain metastases
    4. Pre-existing grade > 1 motor or sensory neuropathy according to the National Cancer Institute Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 4.0.
    5. Myocardial infarct within six months before enrolment, New York Association (NYHA) Class II or worse heart failure (Appendix 1. The
    New York Heart Association), uncontrolled angina, severe uncontrolled ventricular arrythmias, clinically significant pericardial
    disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
    6. History of liver disease.
    7. Concurrent severe medical problems or any unstable medical condition unrelated to malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
    8. Breastfeeding women and women of child bearing potential must use effective contraception during treatment and 3 months thereafter, which may include prescription contraceptives (oral, injection, or patch), intrauterine device, double-barrier method or male partner sterilization (not applicable to patients that are surgically sterile)
    9. Prior exposure to trabectedin
    10. Prior resistance to anthracyclines or PLD defined as a progression during anthracycline based chemotherapy or a recurrence within 6 months from its ending
    11. Prior severe PLD related toxicity
    12. Prior exposure to cumulative doses of doxorubicin >400mg/m2 or epirubicin >720mg/m2
    13. Treatment with any investigational product within 30 days prior to inclusion in the study
    1.Tumores ováricos no epiteliales o epiteliales/no epiteliales mixtos (p. ej., tumores mullerianos).
    2.Pacientes que no han respondido al último tratamiento a base de platino o cuya última recidiva apareció < 6 meses o > 12 meses después de la última dosis de platino.
    3.Obstrucción intestinal, enfermedad suboclusiva o presencia de metástasis cerebrales sintomáticas.
    4.Neuropatía motora o sensitiva de grado > 1 preexistente conforme a los Criterios terminológicos comunes de acontecimientos adversos del National Cancer Institute (CTCAE del NCI), versión 4.0.
    5.Infarto de miocardio en los seis meses anteriores a la inclusión, insuficiencia cardíaca de clase II o superior según la clasificación de la New York Heart Association (NYHA) (Apéndice 1. Clasificación de la New York Heart Association), angina de pecho no controlada, arritmias ventriculares graves no controladas, enfermedad pericárdica con importancia clínica o datos electrocardiográficos de anomalías isquémicas agudas o anomalías activas del sistema de conducción.
    6.Antecedentes de hepatopatía.
    7.Problemas médicos graves coexistentes o cualquier afección médica inestable no relacionada con una neoplasia maligna que puedan limitar de forma significativa el cumplimiento íntegro del ensayo o exponer a la paciente a un riesgo extremo o a una reducción de la esperanza de vida.
    8.Las mujeres en período de lactancia y las mujeres en edad fértil deben emplear un método anticonceptivo eficaz durante el tratamiento y durante 3 meses a partir de entonces, como anticonceptivos bajo prescripción médica (orales, inyectables o en parche), dispositivo intrauterino, método de doble barrera o esterilización de la pareja (no aplicable a las pacientes que hayan sido esterilizadas quirúrgicamente).
    9.Exposición previa a trabectedina.
    10.Resistencia previa a antraciclinas o DLP definida como progresión durante la quimioterapia a base de antraciclinas o recidiva en los 6 meses siguientes a su finalización.
    11.Toxicidad intensa relacionada con DLP previa.
    12.Exposición previa a dosis acumuladas de doxorrubicina > 400 mg/m2 o de epirrubicina > 720 mg/m2.
    13.Tratamiento con cualquier producto en investigación en los 30 días anteriores a la inclusión en el ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS)
    Supervivencia global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    To be measured from the date of randomization up to the date of death due to any cause or, for living patients, the date of last contact.
    Se medirá entre la fecha de aleatorización y la fecha de la muerte por cualquier causa o, en las pacientes vivas, la fecha del último contacto.
    E.5.2Secondary end point(s)
    Efficacy
    Eficacia
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS: will be measured from the date of randomization to the date of documented PD or death (regardless of cause of death).
    La SSP se calculará como el tiempo transcurrido entre la aleatorización y la progresión o la muerte (independientemente de la causa)
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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) Yes
    E.8.2.2Placebo No
    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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA110
    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
    Belgium
    Denmark
    Finland
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    Date of death or the date of last contact
    Fecha de la muerte o fecha del último contacto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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.1.1Number of subjects for this age range: 0
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 570
    F.4.2.2In the whole clinical trial 600
    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)
    Expected and standard treatment of care for the condition
    Tratamiento esperado y estándar para la enfermedad
    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 Decision2014-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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