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    Summary
    EudraCT Number:2012-002447-14
    Sponsor's Protocol Code Number:TV1011-LC-303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-29
    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 number2012-002447-14
    A.3Full title of the trial
    A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
    Estudio fase III multinacional, aleatorizado, abierto de custirsen (TV-1011/OGX-011) en combinación con docetaxel frente a docetaxel como tratamiento de segunda línea en pacientes con cáncer de pulmón no microcítico avanzado o metastásico (estadio IV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out if being treated with docetaxel and custirsen (new experimental drug) can increase survival in patients with advanced or metastatic non-small cell lung cancer, compared to the treatment with docetaxel alone. The patients must have received one prior line of platinum-based systemic anticancer therapy.
    Estudio para averiguar si el tratamiento con docetaxel y custirsen (nuevo fármaco experimental) puede aumentar la supervivencia en pacientes con cáncer de pulmón no microcítico avanzado o metastásico comparado con el tratamiento único con docetaxel. Los pacientes deben haber recibido una línea previa de tratamiento antineoplásico sistémico a base de platino.
    A.3.2Name or abbreviated title of the trial where available
    ENSPIRIT
    A.4.1Sponsor's protocol code numberTV1011-LC-303
    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 SponsorTeva Pharmaceutical Industries, Ltd
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries, Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldecker Str. 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number00000000
    B.5.5Fax number00000000
    B.5.6E-mailInfo.era-clinical@teva.de
    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 nameCustirsen 20mg/ml concentrate for solution for infusion
    D.3.2Product code OGX-011, TV-1011
    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 INNcustirsen
    D.3.9.1CAS number 685922-56-9
    D.3.9.2Current sponsor codeOGX-011, TV-1011
    D.3.9.3Other descriptive nameCustirsen 20mg/ml concentrado para solución para perfusión
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 Yes
    D.3.11.13.1Other medicinal product typeOligonucleótido antisentido
    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
    Non-Small Cell Lung Cancer stage IV
    Cáncer de pulmón no microcítico estadío IV
    E.1.1.1Medical condition in easily understood language
    metastatic Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico metastásico
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if the combination regimen of custirsen and docetaxel improves the Overall Survival (OS) of patients with advanced or metastatic (Stage IV) NSCLC who have received one prior line of platinum-based systemic anticancer therapy.
    Evaluar si el régimen combinado de custirsen y docetaxel mejora la supervivencia global (SG) de pacientes con cáncer de pulmón no microcítico (CPNM)avanzado o metastásico (estadio IV) que han recibido una línea previa de tratamiento antineoplásico sistémico a base de platino.
    E.2.2Secondary objectives of the trial
    Efficacy:
    1.To compare Progression Free Survival (PFS) between patients receiving docetaxel with or without custirsen.
    2.To compare Objective Response Rate (ORR) between patients receiving docetaxel with or without custirsen.
    3.To compare Duration of Objective Response between patients receiving docetaxel with or without custirsen
    4.To compare Disease Control Rate (DCR) between patients receiving docetaxel with or without custirsen
    5.To compare Duration of Disease Control (DC), between patients receiving docetaxel with or without custirsen.

    Safety:
    To assess the safety profile of custirsen in combination with docetaxel.
    Eficacia:
    1.Comparar la supervivencia sin progresión (SSP) entre los pacientes que reciban docetaxel con o sin custirsen.
    2.Comparar la tasa de respuestas objetivas (TRO) entre los pacientes que reciban docetaxel con o sin custirsen.
    3.Comparar la duración de la respuesta objetiva entre los pacientes que reciban docetaxel con o sin custirsen.
    4.Comparar la tasa de control de la enfermedad (TCE) entre los pacientes que reciban docetaxel con o sin custirsen.
    5.Comparar la duración del control de la enfermedad (CE) entre los pacientes que reciban docetaxel con o sin custirsen.
    Seguridad:
    -Evaluar el perfil de seguridad de custirsen en combinación con docetaxel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IV per American Joint Committee on Cancer 7th edition of tumor, nodes and metastases classification of malignant tumors [TNM] staging) NSCLC
    2.Males or females > or =18 years of age at screening.
    3.Life expectancy of > 12 weeks from screening, according to the Investigator's assessment.
    4.Patients must have received one prior line of platinum-based systemic anticancer therapy for advanced or metastatic NSCLC. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued at the end of a treatment regimen.
    5.Patients must have documented radiological disease progression either during or after the first-line therapy.
    6.Patients must have at least one measurable lesion per RECIST 1.1 criteria.
    7.ECOG PS of 0 or 1 at screening.
    8.Have adequate bone marrow, renal and liver functions at screening as defined below:
    -Absolute neutrophil count (ANC) > or = 1.5 x 109/L
    -Platelet count > or = 100 x 109/L
    -Hemoglobin > or = 9 g/dL
    -Serum creatinine < or = 1.5 x upper limit of normal (ULN)
    -Total Bilirubin < or =1.0 x ULN (unless elevated secondary to benign conditions such as Gilbert?s disease)
    -Aspartate transaminase (AST) and alanine transaminase (ALT)< or =1.5 x ULN
    9.Resolution of any toxic effects of prior therapy to Grade < or = 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 (exception of alopecia and < or = 2 Grade 2 peripheral neuropathy).
    10.Females of child-bearing potential must have negative serum pregnancy test within 72 hours before randomization.
    11.Women of child-bearing potential will practice a highly effective method of birth control during and for 3 months after the chemotherapy/custirsen last dose. Male partners of women of child-bearing potential can be either surgically sterile, or will ensure that their female partner utilizes a highly effective contraceptive method during and for 3 months after chemotherapy/custirsen last dose.
    12.Patients must be willing and able to give written informed consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study
    1.Los pacientes deberán tener un CPNM avanzado o metastásico (estadio IV según la 7ª edición del sistema de estadificación TNM [clasificación de los tumores malignos según el tumor, los ganglios y las metástasis] del American Joint Committee on Cancer [AJCC]), irresecable y confirmado por técnicas histológicas o citológicas.
    2.Varones o mujeres con una edad > ó = a 18 años en el momento de selección.
    3.Esperanza de vida mayor de 12 semanas a partir de la selección, según la evaluación del investigador.
    4.Los pacientes tendrán que haber recibido una línea previa de tratamiento antineoplásico sistémico a base de platino por CNMP avanzado o metastásico. Se permitirá el tratamiento de mantenimiento previo y se considerará la misma línea de tratamiento cuando se continúe con él al final de un régimen de tratamiento.
    5.Los pacientes deberán presentar progresión radiológica de la enfermedad confirmada durante o después del tratamiento de primera línea.
    6.Los pacientes deberán tener al menos una lesión mensurable según los criterios RECIST 1.1.
    7.EF del ECOG de 0 o 1 en el momento de selección.
    8.Funciones medular, renal y hepática adecuadas en el momento de selección, según se define a continuación:
    -Recuento absoluto de neutrófilos (RAN) > ó = 1,5 × 109/l.
    -Recuento de plaquetas > ó = 100 x 109 /l.
    -Hemoglobina > ó = 9 g/dl.
    -Creatinina sérica < ó = 1,5 veces el límite superior de la normalidad (LSN).
    -Bilirrubina total < ó = 1,0 veces el LSN (a menos que la elevación sea secundaria a enfermedades benignas, como la enfermedad de Gilbert).
    -Aspartato transaminasa (AST) y alanina aminotransferasa (ALT) < ó = 1,5 veces el LSN.
    9.Resolución de cualquier efecto tóxico del tratamiento previo hasta un grado < ó = 1 según los Criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute (CTCAE del NCI), versión 4.0 (excepto alopecia y neuropatía periférica de grado < ó = 2).
    10.Las mujeres en edad fértil deberán dar negativo en una prueba de embarazo en suero realizada en las 72 horas previas a la aleatorización.
    11.Las mujeres en edad fértil tendrán que emplear un método anticonceptivo muy eficaz durante la administración de quimioterapia/custirsen y durante 3 meses después de la última dosis de quimioterapia/custirsen. Las parejas de mujeres en edad fértil podrán estar esterilizadas quirúrgicamente o se asegurarán de que su pareja emplee un método anticonceptivo muy eficaz durante la administración de quimioterapia/custirsen y durante 3 meses después de la última dosis de quimioterapia/custirsen.
    12.Los pacientes deberán estar dispuestos y ser capaces de otorgar su consentimiento informado por escrito antes de realizar ningún procedimiento específico del protocolo y de cumplir los requisitos del protocolo durante todo el estudio.
    E.4Principal exclusion criteria
    1.Patients treated with any systemic anti-cancer therapy for NSCLC within 21 days prior to randomization (6 weeks for bevacizumab).
    2.Radiotherapy < or = 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
    3.Major surgical procedure within 4 weeks prior to randomization. Patient must have recovered from all surgery-related complications.
    4.Patients with known central nervous system (CNS) metastases (Patients with any clinical signs of CNS metastases must have a CT or MRI of the brain to rule out CNS metastases in order to be eligible for participation in the study. Patients who have had brain metastases treated with radiotherapy or surgically removed with no residual disease confirmed by imaging should be clinically stable and off corticosteroid treatment at least 3 weeks prior to randomization).
    5.Patients with current diagnosis or a history of another active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 5 years previously with no evidence of recurrence).
    6.Severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (> or = Grade 2, according to NCI CTCAE v4.0) or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
    7.A history of events such as myocardial infarction, cerebrovascular accident (CVA) or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
    8.Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
    9.Female patients who are breastfeeding.
    10.Patients previously treated with docetaxel for NSCLC or with known severe hypersensitivity to taxane therapies.
    1.Pacientes tratados con cualquier tratamiento antineoplásico sistémico para el CPNM en los 21 días previos a la aleatorización (6 semanas en el caso de bevacizumab).
    2.Radioterapia < ó = 2 semanas antes de la aleatorización. Los pacientes deberán haberse recuperado de todos los efectos tóxicos relacionados con la radioterapia.
    3.Intervención de cirugía mayor en las 4 semanas previas a la aleatorización. Los pacientes deberán haberse recuperado de todas las complicaciones relacionadas con la cirugía.
    4.Pacientes con metástasis conocidas en el sistema nervioso central (SNC) (los pacientes con signos clínicos de metástasis en el SNC deberán someterse a una TC o RM cerebral para descartar metástasis en el SNC a fin de poder participar en el estudio. Los pacientes que hayan tenido metástasis cerebrales tratadas con radioterapia o extirpación quirúrgica sin enfermedad residual confirmada mediante técnicas de imagen deberán encontrarse clínicamente estables y sin recibir tratamiento con corticoides al menos 3 semanas antes de la aleatorización).
    5.Pacientes con diagnóstico actual o antecedentes de otra neoplasia maligna primaria activa (salvo carcinoma in situ del cuello uterino, cáncer de piel distinto del melanoma debidamente tratado, cáncer de próstata clínicamente localizado, cáncer de vejiga superficial u otra neoplasia maligna tratada al menos 5 años antes sin signos de recidiva).
    6.Enfermedades graves o inestables tales como insuficiencia cardíaca, cardiopatía isquémica, hipertensión no controlada, diabetes mellitus no controlada o enfermedad psiquiátrica, así como una arritmia cardíaca en curso con necesidad de medicación (grado > ó = 2, según los CTCAE del NCI versión 4.0) o cualquier otra enfermedad concomitante importante o inestable que, en opinión del investigador, descartaría el uso del tratamiento del estudio.
    7.Antecedentes de episodios tales como infarto de miocardio, accidente cerebrovascular (ACV) o hepatitis aguda en los 3 meses previos a la aleatorización o tratamiento de una infección activa importante en el mes previo a la aleatorización o cualquier otro episodio importante que, en opinión del investigador, descartaría el uso del tratamiento del estudio.
    8.Participación concomitante prevista en otro ensayo clínico de un agente experimental, vacuna o dispositivo en investigación. La participación concomitante en estudios observacionales será aceptable.
    9.Mujeres lactantes.
    10.Pacientes tratados previamente con docetaxel para el CPNM o con hipersensibilidad intensa conocida a tratamientos con taxanos.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint and variable for the study is OS, defined as the time from date of randomization to the date of death from any cause.
    El criterio de valoración y variable principal de este estudio es la SG, definida como el tiempo transcurrido entre la fecha de aleatorización y la fecha de la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    date of death
    Fecha de muerte
    E.5.2Secondary end point(s)
    -Progression Free Survival (PFS)
    -Objective Response Rate (ORR)
    -Duration of Objective Response
    -Disease Control Rate (DCR)
    -Duration of Disease Control
    Supervivencia sin progresión (SSP)
    Tasa de respuestas objetivas (TRO)
    Duración de la respuesta objetiva (RO)
    Tasa de control de la enfermedad (TCE)
    Duración del control de la enfermedad (CE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PFS, defined as the time from the date of randomization to the first objective documented progression per RECISTv1.1 or death due to any cause,whichever occurs first.
    -OR is defined as achieving a best overall response of CR or PR,as defined using RECISTv1.1.
    -Duration of OR is defined as time from first occurrence of CR or PR (whichever is first recorded) until date of the first documented disease progression or death, whichever occurs first.
    -DC is defined as achieving a best overall response of CR, PR or SD.
    -Duration of DC is defined as the time from randomization to the date of the first documented disease progression or death, whichever occurs first.
    - SSP, definida como el tiempo entre la fecha de aleatorización y la de la primera progresión objetiva confirmada con criterios RECIST, versión1.1 o la muerte por cualquier causa, lo que ocurra primero.
    - RO, definida como la consecución de una mejor respuesta global de RC o RP, según los criterios RECIST, versión1.1.
    - Duración de la RO, definida como el tiempo entre la primera aparición de RC o RP (lo que se registre primero) y la fecha de la primera progresión confirmada de la enfermedad o la muerte, lo que ocurra primero.
    - CE, definido como la consecución de una mejor respuesta global de RC, RP o EE.
    - Duración del CE, definida como el tiempo transcurrido entre la aleatorización y la fecha de la primera progresión confirmada de la enfermedad o la muerte, lo que ocurra primero.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To compare the arms with respect to Quality of Life (QoL) parameters Functional Assessment of Cancer Therapy - Lung (FACT-L) and Euro Quality of Life - 5D (EQ-5D)
    Comparar los grupos en cuanto a parámetros relacionados con la calidad de vida (CdV): cuestionarios FACT-L (Evaluación funcional del tratamiento del cáncer-pulmón) y EQ-5D (EuroQoL 5-D).
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Docetaxel 75 mg/m2 IV el día 1 de cada ciclo de 21 días
    Docetaxel 75 mg/m2 IV on Day 1 of every 21-day cycle
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA109
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Bulgaria
    China
    Croatia
    France
    Georgia
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Singapore
    Spain
    Taiwan
    Thailand
    Ukraine
    United States
    Vietnam
    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
    2 formal interim analyses are planned for stopping the trial early based on inadequate evidence of clin. benefit or futility:see stop criteria pg11-protocol.If study continues final efficacy analysis is planned after 850death events.All pts who discont.study treatm. will be followed to collect further anticancer treatment and survival information until death,loss to follow-up,withdrawal of consent,or up to 12months after end of treatment visit for last patient on the study,whichever comes first.
    Están previstos 2 análisis para interrumpir prematuramente el estudio si hay datos insuficientes de beneficio clínico o inutilidad. Si continúa está planeado un análisis de eficacia final tras 850muertes. Pacientes que suspendan el tto serán objeto de seguimiento para obtener info. adicional relativa al tto antineoplásico y la supervivencia hasta muerte, pérdida de seguimiento o retirada del consentimiento o hasta 12m tras la visita de fin tto del último paciente del estudio, lo que ocurra antes
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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: 440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 660
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 463
    F.4.2.2In the whole clinical trial 1100
    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)
    All patients who discontinued study treatment will be followed to
    collect further anticancer treatment and survival information until death, loss to
    follow-up, withdrawal of consent, or up to 12 months after the end of treatment
    visit for the last patient on the study, whichever comes first. Patients who are removed from study treatment for any reason other than disease progression or
    death will be followed for documented radiological disease progression.
    Pacientes que suspendan el tto. serán objeto de seguimiento para obtener info. adicional relativa al tto. antineoplásico y a la supervivencia hasta muerte, pérdida de seguimiento o retirada del consentimiento o hasta 12m tras la visita fin de tto. del último paciente del estudio, lo que ocurra antes. Los pacientes que dejen de recibir el tto. por cualquier motivo distinto de progresión de enfermedad o muerte serán objeto de seguimiento para determinar la progresión radiológica de 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 Decision2012-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-11-17
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