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    Summary
    EudraCT Number:2012-001896-35
    Sponsor's Protocol Code Number:ETOP3-12
    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:2012-10-15
    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 number2012-001896-35
    A.3Full title of the trial
    A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor
    Ensayo Fase III, aleatorizado, de erlotinib versus docetaxel, según el test Veristrat, en pacientes con cáncer de pulmón no microcítico epidermoide avanzado, tras fracaso a una primera línea de quimioterapia basada en un doblete con platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Testing of the two drugs erlotinib and docetaxel in lung cancer patients who have been classified regarding their outlook using VeriStrat®.
    Test genético de Veristrat para distribuir a los pacientes en dos brazos y tratarlos con Docetaxel o Erlotinib
    A.3.2Name or abbreviated title of the trial where available
    EMPHASIS-lung: Erlotinib Maldi TOF Phase III Signature in Squamous cell non-small cell lung cancer
    EMPHASIS-lung: Ensayo Fase III de Erlotinib versus Docetaxel en pacientes con CPNM
    A.4.1Sponsor's protocol code numberETOP3-12
    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 SponsorETOP (European Thoracic Oncology Platform)
    B.1.3.4CountrySwitzerland
    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 supportBiodesix, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationETOP
    B.5.2Functional name of contact pointETOP Coordinating Office
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4131389 93 91
    B.5.5Fax number+4131389 93 92
    B.5.6E-mailemphasis@etop-eu.org
    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.2.5The 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.3.4Pharmaceutical 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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    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 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.3.4Pharmaceutical 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 INNERLOTINIB HYDROCHLORIDE
    D.3.9.1CAS number 183319-69-9
    D.3.9.4EV Substance CodeSUB21050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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.3.4Pharmaceutical form 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 INNDOCETAXEL TRIHYDRATE
    D.3.9.1CAS number 148408-66-6
    D.3.9.4EV Substance CodeSUB21602
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Squamous cell non-small cell lung cancer in patients who have failed first-line platinum-based doublet chemotherapy.
    Pacientes con cáncer de pulmón no microcítico epidermoide que fracasan a una primera linea con un doblete con platinos
    E.1.1.1Medical condition in easily understood language
    Lung cancer in patients who failed first-line chemotherapy.
    Pacientes con cáncer de pulmón que fracasan a una primera linea de quimioterapia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Explore the predictive ability of VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (Good vs Poor) using progression free survival as outcome.
    Explorar la habilidad de la firma genética Veristrat (poor/good) para testar la interacción entre las dos ramas de tratamiento (BRazo A: Erlotinib; Brazo B: Docetaxel) usando la progresión libre de enfermedad como resultado.
    E.2.2Secondary objectives of the trial
    - Explore whether treatment with erlotinib provides progression free survival (PFS) benefit compared to docetaxel in the VSG (VeriStrat Good) group.
    - Compare PFS in the two treatment arms (erlotinib vs docetaxel) in the VSP (VeriStrat Poor) group.
    - Explore the prognostic ability of VeriStrat signature by testing for an overall difference in PFS between the 2 VeriStrat groups.
    - Explore the predictive ability of the VeriStrat signature using the secondary measures of clinical efficacy including overall survival (OS), objective response rate, and disease control rate.
    - Compare OS, objective response rate and disease control rate between treatment groups separately in the VSG / VSP groups.
    - Explore the prognostic ability of the VeriStrat signature by testing for an overall difference in OS, objective response rate and disease control rate between the 2 VeriStrat groups.
    - Assess the safety and tolerability of the 2 treatments separately in each VeriStrat group and overall.
    2. Explorar si el tratamiento con erlotinib proporciona una mejora de la supervivencia libre de progresión
    3. Comparar la supervivencia libre de progresión en los dos grupos de tratamiento
    4. Explorar la capacidad pronóstica del resultado de VeriStrat mediante el examen de la diferencia global en la supervivencia libre de progresión entre los dos grupos de VeriStrat
    5. Explorar la capacidad pronóstica del resultado de VeriStrat utilizando parámetros secundarios de la eficacia clínica, tales SG, la tasa de resp. objetiva y la tasa de control de la enfermedad.
    6. Comparar la SG, la tasa de respuesta objetiva y la tasa de control de la enfermedad entre los grupos de tratamiento en los grupos VSG y VSP.
    7. Explorar la capacidad pronóstica del resultado de VeriStrat mediante el estudio de la diferencia global en la SG, la tasa de respuesta objetiva y la tasa de control de la enfermedad entre los dos grupos
    8. Evaluar la seguridad y la tolerabilidad de los dos tratamientos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically confirmed locally advanced stage IIIB, not amenable to radical radiotherapy, or metastatic stage IV non-small cell lung cancer (NSCLC) of predominant squamous subtype, according to the 7th edition of the TNM classification, including M1a (separate
    tumor nodule in a contralateral lobe, tumor with pleural nodules or malignant pleural or pericardial effusion) and/or M1b (distant metastasis).
    - Progressive disease upon or after previous chemotherapy including at least one line of platinum-based chemotherapy.
    - Adjuvant platinum-based chemotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration.
    - Platinum-based chemotherapy combined with definitive
    radiotherapy can be considered as platinum-based chemotherapy line if administration ended in the 6 months before registration.
    Measurable or evaluable disease according to RECIST v1.1 .
    ECOG performance status 0-2.
    - Age ? 18 years.
    - Adequate organ function, including:
    - Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
    - Hepatic: bilirubin <1.5 x ULN; AP, ALT < 3.0 x ULN; AP, ALT <5 x ULN is acceptable in case of liver metastasis.
    - Renal: calculated creatinine clearance > 40 ml/min based on the Cockroft and Gault formula.
    - Signed and dated informed consent form.
    - Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with reproductive potential must have a negative serum or urin pregnancy test within 7 days prior to study registration. Non-reproductive potential for females is defined as surgically sterile or post-menopausal defined as ?24 months since last menses. Male patients are considered to have reproductive potential unless they are surgically sterile.
    - Estimated life expectancy >12 weeks.
    - Patient compliance and geographical proximity that allow adequate follow-up.
    1. Cáncer de pulmón no microcítico (CPNM) confirmado histológica o citológicamente, en estadio IIIB, localmente avanzado, no susceptible de radioterapia radical, o en estadio IV, metastásico, de subtipo predominantemente epidermoide, según la 7ª edición de la clasificación TNM, incluidos M1a (nódulo tumoral separado en un lóbulo contralateral, tumor con nódulos pleurales o derrame pleural o pericárdico maligno) y/o M1b (metástasis a distancia).
    2. Enfermedad progresiva durante la quimioterapia previa o tras ella, incluida como mínimo una línea de quimioterapia basada en el platino.
    3. Enfermedad medible o evaluable según los criterios RECIST v1.1 (Anexo 2).
    4. Estado funcional del ECOG 0-2.
    5. Edad ? 18 años.
    6. Función orgánica adecuada, lo que incluye:
    Reserva adecuada de médula ósea: RAN > 1,5 x 109/L, plaquetas > 100 x 109/L.
    Función hepática: bilirrubina < 1,5 x LSN; FA, ALT < 3,0 x LSN; se puede aceptar FA, ALT < 5 x LSN en caso de metástasis hepática.
    Función renal: aclaramiento de creatinina calculado> 40 ml/min según la fórmula de Cockroft y Gault.
    7. Documento de consentimiento informado firmado y fechado.
    8. Los pacientes de ambos sexos potencialmente fértiles deberán utilizar un método anticonceptivo aprobado, durante el ensayo y los 12 meses siguientes. Las mujeres potencialmente fértiles deberán tener un resultado negativo en una prueba de embarazo en los siete días previos a su registro en el estudio.
    9. Estimación de esperanza de vida > 12 semanas.
    10. Aceptación por el paciente y proximidad geográfica que permita un seguimiento adecuado.
    E.4Principal exclusion criteria
    - Evidence of other medical conditions which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus).
    - Previous treatment with any EGFR-TKI or docetaxel.
    - Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least 14 days prior to registration.
    - Documented presence of activating EGFR mutations, if patient was tested for EGFR mutations.
    - Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ, breast cancer in situ or localized nonmelanoma skin cancer.
    - Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, or interfering with compliance for oral drug intake.
    - Concurrent treatment with experimental drugs or other anti-cancer therapy treatment in a clinical trial within 21 days prior to registration.
    - Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs or any concomitant drugs contraindicated.
    - Pregnant women
    - Nursing women
    1. Signos de cualquier otro proceso médico que pueda afectar a la capacidad del paciente para participar en el ensayo o imposibilitar el tratamiento con los fármacos del estudio (por ejemplo, enfermedad inestable o descompensada de índole respiratoria, cardiaca, hepática o renal, infección activa, diabetes mellitus no controlada).
    2. Tratamiento previo con cualquier inhibidor de la tirosina-cinasa del EGFR o con docetaxel.
    3. Metástasis cerebrales confirmadas, salvo si el paciente hubiera completado un tratamiento local para metástasis en el sistema nervioso central y llevara sin recibir corticosteroides al menos los 14 días previos a su registro en el estudio.
    4. Presencia documentada de mutaciones activadoras del EGFR, en caso de que se hayan analizado en el paciente dichas mutaciones.
    5. Neoplasia maligna previa en los 5 últimos años, con la excepción de carcinoma in situ de cuello uterino, cáncer de mama in situ o cáncer cutáneo no melanoma de tipo localizado, adecuadamente tratados.
    6. Trastorno psiquiátrico que afecte a la comprensión de la información sobre los aspectos del ensayo o al otorgamiento del consentimiento informado o que interfiera en la toma de fármacos por vía oral.
    7. Tratamiento concomitante con fármacos en fase de desarrollo u otro tratamiento antineoplásico en un ensayo clínico en los 21 días previos al registro en el estudio.
    8. Hipersensibilidad conocida a los fármacos del ensayo o a cualquier otro componente de los fármacos del ensayo o contraindicación de cualquier medicamento concomitante.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival. Defined as the time from the date of randomization until documented progression or death without documented progression.
    Progresión libre de enfermedad definida como el tiempo transcurrido desde la fecha de randomización hasta la progresión documentada o muerte sin progresión documentada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final evaluation will be done within 6 months after the two-month visit of the last entered patient, approximately 26 months after the inclusion of the first patient.
    La evaluación final se llevará a cabo dentro de los 6 meses después de la visita de dos meses del último paciente ingresado, aproximadamente 26 meses después de la inclusión del primer paciente.
    E.5.2Secondary end point(s)
    - Overall survival. Defined as time from the date of randomization until death from any cause.
    - Objective response. Defined as best overall response (CR or PR) across all assessment time-points according to RECIST Criteria 1.1 during the period from randomization to termination of trial treatment.
    - Disease control. Defined as achieving objective response or stable disease for at least 6 weeks.
    - Toxicities of treatment. Adverse events classified according to NCI CTCAE version 4.
    -Supervivencia global
    Se define como el tiempo entre la fecha de la aleatorización y el fallecimiento por cualquier causa.
    -Respuesta objetiva
    La respuesta objetiva se define como la mejor respuesta global (respuesta completa [RC] o respuesta parcial [RP]) en todos los puntos de tiempo de evaluación conforme a los criterios RECIST 1.1 (véase Anexo 2), durante el periodo entre la aleatorización y la terminación del tratamiento del ensayo.
    -Control de la enfermedad
    Se define como control de la enfermedad la consecución de respuesta objetiva o enfermedad estable durante un mínimo de 6 semanas.
    -Toxicidades del tratamiento
    Es la clasificación de los acontecimientos adversos conforme a los CTCAE del NCI, versión 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final evaluation will be done within 6 months after the two-month visit of the last entered patient, approximately 26 months after the inclusion of the first patient.
    La evaluación final se llevará a cabo dentro de los 6 meses después de la visita de dos meses del último paciente ingresado, aproximadamente 26 meses después de la inclusión del primer paciente.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Prospectively evaluate predictive and prognostic value of proteomic (VeriStrat) test
    Evaluar de forma prospectiva el valor pronóstico y predictivo de la prueba proteómica (VeriStrat)
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Austria
    Belgium
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Netherlands
    Portugal
    Spain
    Switzerland
    United Kingdom
    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
    Accrual is to be completed 18 months after first patient randomization. The run-in period/treatment/follow-up for PFS extends the study duration to 24 months (6 months after last patient is randomized). All patients are followed for survival status every 12 weeks thereafter, until death, or up to 24 months after the last patient is randomized, at which time the study will formally end. The preparation of the study report is scheduled for 26 months after the first patient is enrolled.
    El reclutamiento debe ser completado 18 meses después de la aleatorización del primer paciente. El periodo de tratamiento / seguimiento de la SSP se extiende 24 meses (6 meses después del último paciente randomizado). Todos los pacientes son seguidos para supervivencia cada 12 semanas a partir de entonces, hasta la muerte, o hasta 24 meses después del último paciente es aleatorizado, momento en el que el estudio concluirá.
    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 months2
    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 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 500
    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)
    No treatment or care specified.
    español



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    No existe ningún tratamiento o cuidado especificado.
    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 Decision2012-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
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