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    Summary
    EudraCT Number:2010-023377-19
    Sponsor's Protocol Code Number:D2610C00004
    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:2011-09-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-023377-19
    A.3Full title of the trial
    A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE)
    Ensayo abierto, aleatorizado fase IIA, para evaluar la eficacia y la seguridad de AZD4547 en monoterapia frente a paclitaxel en pacientes con cáncer gástrico o de la unión gastroesofágica avanzado y con polisomía o amplificación génica de FGFR2 (Estudio Shine)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of AZD4547 versus paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer patients
    Seguridad y eficacia de AZD4547 frente a paclitaxel en pacientes con cáncer gástrico o de la unión gastroesofágica avanzado
    A.3.2Name or abbreviated title of the trial where available
    SHINE
    A.4.1Sponsor's protocol code numberD2610C00004
    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 SponsorAstraZeneca
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountrySweden
    B.5.4Telephone numbern/an/an/an/a
    B.5.5Fax numbern/an/an/an/a
    B.5.6E-mailinformation.centre@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 nameAZD4547 comprimido recubierto
    D.3.2Product code AZD4547
    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.3.9.1CAS number 1035270-39-3
    D.3.9.2Current sponsor codeAZD4547
    D.3.9.3Other descriptive nameN-[5-[2-(3,5-dimethoxyphenyl)ethyl]-1Hpyrazol-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.2.1.1.1Trade name Paclitaxel 6mg/ml concentrate for solution for infusion Paclitaxel 6mg/ml concentrado para solución para infusión
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK
    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 namePaclitaxel 6mg/ml concentrate for solution for infusion
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codePACLITAXEL
    D.3.9.3Other descriptive namePACLITAXEL
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    FGFR, Amplification, polysomy, gastro-oesophageal junction cancer, gastric cancer, randomised, efficacy
    FGFR, amplificación, polisomía, cáncer de la unión gastroesofágica, cáncer gástrico, aleatorización, eficacia
    E.1.1.1Medical condition in easily understood language
    stomach and food-pipe cancer, anti-tumour activity, high number of copies of gene driving cancer
    cáncer de estómago y esófago, actividad anti-tumoral, número alto de copias de genes que producen cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10030159
    E.1.2Term Oesophageal carcinoma 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10061967
    E.1.2Term Gastric 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10030155
    E.1.2Term Oesophageal carcinoma
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10017761
    E.1.2Term Gastric 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 14.0
    E.1.2Level PT
    E.1.2Classification code 10017765
    E.1.2Term Gastric 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
    To assess the relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone.
    Valorar la eficacia relativa de AZD4547 en comparación con paclitaxel mediante comparación del cambio del tamaño tumoral a las 8 semanas en todos los pacientes aleatorizados y también exclusivamente en los pacientes con tumores que tienen amplificación de FGFR2 (puntuación de FISH 6).
    E.2.2Secondary objectives of the trial
    To assess the relative efficacy of AZD4547 compared with paclitaxel by assessment of progression-free survival (PFS) in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone.
    To investigate the efficacy of AZD4547 compared with paclitaxel by assessment of objective response rate (ORR) in all randomised patients and also in the patients with tumours that have FGFR2 amplification (FISH score 6) alone
    To assess the efficacy of AZD4547 and paclitaxel by assessment of the percentage of patients without progressive disease at 8 weeks.
    To compare and assess the safety and tolerability of AZD4547 and paclitaxel.
    To investigate the PK of AZD4547 in an advanced gastric cancer patient population.
    To investigate the possible pharmacokinetic/pharmacodynamic (PK/PD) relationships between plasma AZD4547 exposure and plasma concentrations of phosphate, bFGF, FGF23 and efficacy and other exploratory PD endpoints.
    Evaluar eficacia relativa de AZD4547 en comparación con paclitaxel mediante la evaluación de la supervivencia libre de progresión (SLP) en los pacs aleatorizados y tb. exclusivamente en los pacs. con tumores que tienen amplificación de FGFR2 (FISH 6).
    Investigar la eficacia de AZD4547 en comparación con paclitaxel mediante evaluación de la tasa de respuestas objetivas (TRO) en los pacs. aleatorizados y tb. exclusivamente en los pacs, con tumores que tienen amplificación de FGFR2 (FISH 6).
    Evaluar la eficacia de AZD4547 y paclitaxel mediante la evaluación del % de pacs. sin progresión de la enfermedad a las 8 semanas.
    Comparar y evaluar la seguridad y la tolerabilidad de AZD4547 y paclitaxel.
    Investigar la FC de AZD4547 en una población de pacs. con cáncer gástrico avanzado.
    Investigar las posibles relaciones FC/FD entre la exposición a AZD4547 en el plasma y las concentraciones plasmáticas de fosfato, bFGF, FGF23 y la eficacia y otros criterios de valoración FD exploratorios.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genetic sub-study: see protocol and ICF for genetic investigation
    Objectives: to explore how genetic variations may affect the clinical parameters associated with AZD4547. Collection of DNA samples from populations with well-described clinical characteristics may lead to improvements in the design and interpretation of clinical studies and possibly to genetically guided treatment strategies.
    Sub-study genético: ver protocolo y HIP y CI para investigación genética
    Objetivos: Explorar el modo en que las variaciones genéticas pueden afectar a los parámetros clínicos asociados a AZD4547. La recogida de muestras de ADN de poblaciones con características clínicas bien descritas puede conducir a la mejora en el diseño y la interpretación de los ensayos clínicos y posiblemente a estrategias de tratamiento orientadas genéticamente.
    E.3Principal inclusion criteria
    Female or male aged 25 or over
    Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
    Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
    At least one lesion, not previously irradiated, that at baseline is equal to or larger than 10mm in the longest diameter for non nodal lesions with CT or MRI
    Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification by the sponsor approved laboratory. Patients with FGFR2 polysomy or gene amplified tumours will be eligible for the main study
    Mujer o varón de 25 años o más.
    Diagnóstico histológico de adenocarcinoma gástrico localmente avanzado o metastásico (incluido el adenocarcinoma del tercio inferior del esófago o de la unión gastroesofágica).
    Progresión confirmada radiológicamente después de una quimioterapia o quimiorradioterapia previa para el cáncer gástrico. Pacientes idóneos y que se espere que puedan obtener beneficio con el tratamiento con paclitaxel
    Al menos una lesión, no irradiada previamente, que en el momento basal sea >/= 10 mm en el diámetro más largo para lesiones no nodulares con TC o RM Provisión de una muestra tumoral de archivo o nueva para la confirmación de polisomía o amplificación génica de FGFR2 por un laboratorio autorizado por el promotor. Los pacientes con tumores con polisomía o amplificación génica de FGFR2 serán elegibles para el estudio principal
    E.4Principal exclusion criteria
    Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in Cremaphor EL (polyoxyethylated castor oil)
    Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
    With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
    Blood and ECG readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
    Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.
    Exposición previa a AZD4547 o antecedente de hipersensibilidad a otros fármacos similares en estructura o clase a AZD4547. Hipersensibilidad a paclitaxel o u otros fármacos formulados en Cremaphor EL (aceite de ricino polioxietilado)
    Cirugía mayor, radioterapia con un campo amplio de irradiación o cualquier tratamiento para el cáncer en el plazo de 4 semanas antes de la primera dosis del tratamiento en estudio.
    A excepción de la alopecia, cualquier toxicidad no resuelta de tratamiento previo con un grado > 1 de los Criterios de Terminología Común para Acontecimientos Adversos (CTCAE) en el momento de comenzar el tratamiento del ensayo
    Lecturas de sangre y ECG que se consideren anormales por no entrar en el ámbito de los rangos de referencia incluidos en el apartado de criterios de inclusión/exclusión del protocolo.
    Toma regular de medicación que se prevé interactúe con AZD4547 debido a su ruta metabólica.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of relative efficacy of AZD4547 compared with paclitaxel by comparison of the change in tumour size at 8 weeks in all patients and also in patients with FGFR2 amplified tumours (FISH 6) alone
    Evaluar la eficacia relativa de AZD4547 en comparación con paclitaxel comparando el cambio en el tamaño del tumor a las 8 semanas en todos los pacientes y también exclusivamente en los pacientes con tumores que tienen amplificación de FGFR2 (puntuación FISH de 6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Based on RECIST measurements taken at baseline and at week 8.
    Basados en las determinaciones RECIST tomadas al inicio y al a semana 8
    E.5.2Secondary end point(s)
    Relative efficacy of AZD4547 compared with paclitaxel by assessment of progression free survival (defined by RECIST 1.1 or death), in all randomized patients and also in patients with FGFR2 amplified tumours (FISH 6) alone
    Efficacy of AZD4547 compared with paclitaxel by assessment of objective response rate (1 visit response of CR or PR prior to progression as defined by RECIST 1.1) in randomized patients and also in patients with FGFR2 amplified tumours (FISH 6) alone
    Assess the efficacy of AZD4547 and paclitaxel by assessment of the percentage of patients without progressive disease at 8 weeks
    Safety and tolerability of AZD4547 versus paclitaxel by assessing safety information (lab findings, ECG, adverse events, deaths, physical examination, eye asssessments and MUGA/Echo parameters)
    Investigate PK of AZD4547 in advanced gastric cancer patient population.
    Evaluar la eficacia relativa de AZD4547 en comparación con paclitaxel mediante la evaluación de la supervivencia libre de progresión (definida como RECIST 1.1 o muerte) en los pacientes aleatorizados y también exclusivamente en los pacientes con tumores que tienen amplificación de FGFR2 (puntuación FISH 6).
    Investigar la eficacia de AZD4547 en comparación con paclitaxel mediante evaluación de la tasa de respuestas objetivas (1 respuesta a CR o PR antes de la progresión tal como se define en RECIST 1.1) en los pacientes aleatorizados y también exclusivamente en los pacientes con tumores que tienen amplificación de FGFR2 (puntuación FISH de 6).
    Evaluar la eficacia de AZD4547 y paclitaxel mediante la evaluación del porcentaje de pacientes sin progresión de la enfermedad a las 8 semanas.
    Comparar y evaluar la seguridad y la tolerabilidad de AZD4547 y paclitaxel evaluando la información de seguridad (hallazgos de laboratorio, ECG, reacciones adversas, muertes, exámenes físicos, evaluaciones oftálmicas y parámetros MUGA/Echo)
    Investigar la FC de AZD4547 en una población de pacientes con cáncer gástrico avanzado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    RECIST assessments will be performed at baseline and every 8 weeks until progression.
    All safety measures will be collected from screening to 28 days after study drug discontinuation.
    Plasma AZD4547 measured as follows:
    Cycle 1 - Day 8 (pre), Day 15 (pre, 0.5-2, 5-6, 8-12 hrs)
    Cycle 2 - Day 1 (pre), Day 15 (pre, 0.5-2, 5-6, 8-12 hrs)
    Biomarker samples taken during screening, Cycle 1 Day 8 and Day 15, Cycle 3 Day 1 and Day 1 of each subsequent cycle.
    Investigate Possible pharmacokinetic/pharmacodynamic relationships between plasma AZD4547 and levels of phosphate, bFGF, FGF23, efficacy and other exploratory PD endpoints.
    Las determinaciones RECIST se realizarán al inicio y cada 8 semanas hasta la progresión
    Las medidas de seguridad se recogerán desde la aleatorización hasta 28 días después de la interrupción del mdto. en estudio.
    AZD4547 en plasma se medirá de la siguente manera:
    ciclo 1 - día 8 (pre), día 15 (pre, 0.5-2, 5-6, 8-12 hrs)
    ciclo 2 - día 1 (pre), día 15 (pre, 0.5-2, 5-6, 8-12 hrs)
    Las muestras de biomarcadores se tomarán durante el periodo de screening, ciclo 1 días 8 y 15, ciclo 7 día 1 y al día 1 de todos los ciclos posteriores
    Investigación de posibles relaciones farmacocinéticas/farmacodinámicas entre AZD4547 en plasma y niveles de fosfato, bFGF, FGF23, eficacia y otros parámetros de valoración exploratorios farmacodinámicos
    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 Yes
    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 No
    E.8.1.2Open Yes
    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 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
    Belgium
    France
    Germany
    India
    Italy
    Korea, Republic of
    Spain
    Taiwan
    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
    LVLS
    Ultima visita del último paciente
    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 days2
    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 days2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 55
    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)
    Standard of care
    cuidados habituales
    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 Decision2011-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
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