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    Summary
    EudraCT Number:2013-003695-13
    Sponsor's Protocol Code Number:GEXMab52201
    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:2013-10-18
    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 number2013-003695-13
    A.3Full title of the trial
    Randomized, controlled, open label, multicenter, phase II study to evaluate the efficacy and safety of CetuGEX? plus chemotherapy in comparison to cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Estudio aleatorizado, controlado, abierto, multicéntrico, en fase II para evaluar la eficacia y la seguridad de CetuGEX? más quimioterapia en comparación con cetuximab más quimioterapia para el tratamiento de pacientes con carcinoma de células escamosas de cabeza y cuello en estadio III/IV recidivante y/o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    non-blinded phase II study to compare the efficacy and safety of CetuGEX? plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Estudio abierto, fase II para comparar la eficacia y seguridad de CetuGEX? con quimioterapia frente a Cetuximab con quimioterapia, para el tratamiento de pacientes recurrentes en estadío III/IV o metastásicos con carcinoma de células escamosas en cabeza y cuello
    A.3.2Name or abbreviated title of the trial where available
    RESGEX study
    ESTUDIO RESGEX
    A.4.1Sponsor's protocol code numberGEXMab52201
    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 SponsorGlycotope GmbH
    B.1.3.4CountryGermany
    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 supportGlycotope GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlycotope GmbH
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Roessle-Str. 10
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13125
    B.5.3.4CountryGermany
    B.5.4Telephone number+493094892653
    B.5.5Fax number+493094892609
    B.5.6E-mailkathrin.stechmann@glycotope.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 nameCetuGEX
    D.3.4Pharmaceutical form 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 INNCetuGEX
    D.3.9.3Other descriptive nameCETUGEX
    D.3.9.4EV Substance CodeSUB31982
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Erbitux 5 mg/mL solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Carcinoma de células escamosas de cabeza y cuello en estadio III/IV recidivante y/o metastásico
    E.1.1.1Medical condition in easily understood language
    stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Carcinoma de células escamosas de cabeza y cuello en estadio III/IV recidivante y/o 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 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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
    The primary objective of the study is to evaluate the efficacy of CetuGEX? for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of PFS.
    Principal:
    Evaluar la eficacia de CetuGEX? para el tratamiento de pacientes con CCECC en estadio III/IV recidivante y/o metastásico en comparación con cetuximab (ambos en combinación con quimioterapia basada en platino) en cuanto a la supervivencia libre de progresión (SLP).
    E.2.2Secondary objectives of the trial
    Secondary objectives are as follows:
    1. To evaluate further efficacy criteria, safety and QoL of patients with stage III/IV recurrent and/or metastatic SCCHN treated with CetuGEX? as compared to cetuximab (both in combination with platinum-based chemotherapy).
    2. To assess PK parameters and profiles of CetuGEX?.
    3. To assess efficacy and safety based on genetic markers for immune response (Fc?R allotypes) and biomarkers.
    Secundarios:
    Evaluar los criterios adicionales de la eficacia, la seguridad y la calidad de vida (CdV) de los pacientes con CCECC en estadio III/IV recurrente y/o metastásico tratados con CetuGEX? en comparación con cetuximab (ambos en combinación con quimioterapia basada en platino).
    Evaluar los parámetros y perfiles farmacocinéticos (FC) de CetuGEX?.
    Evaluar la eficacia y la seguridad basándose en los marcadores genéticos para la respuesta inmunitaria (alotipos de los receptores Fc gamma [Fc?R]) y en los biomarcadores
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically confirmed recurrent and/or metastatic EGFR positive SCCHN not eligible for local treatment.
    2. Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
    3. Patients aged at least 18 years at screening.
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    5. Minimum life expectancy of 3 months.
    6. Tissue samples available for specific disease and therapy related biological assessments.
    7. If female and of childbearing potential, is non-lactating and has negative pregnancy test results at screening and prior to randomization.
    8. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or using highly effective contraceptives with a failure rate < 1% according to the Note for Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95) of the European Medicines Agency (EMA). Male patients who have partners of childbearing potential have to confirm adequate use of highly effective contraceptives as well.
    9. Willing and able to comply with the protocol.
    10. Willing and able to provide written informed consent.
    Criterios de inclusión:
    1. Pacientes con CCECC EGFR positivo recidivante y/o metastásico histológicamente confirmado no elegibles para recibir tratamiento local.
    2. Pacientes con enfermedad medible según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST) 1.1.
    3. Pacientes de 18 años de edad como mínimo en la selección.
    4. Estado funcional de 0 o 1 del Eastern Cooperative Oncology Group (ECOG)
    5. Esperanza de vida mínima de 3 meses.
    6. Muestras de tejido disponibles para evaluaciones biológicas concretas relacionadas con el tratamiento y la enfermedad.
    7. En el caso de mujeres que puedan quedarse embarazas, no estar en período de lactancia y haber obtenido resultados negativos en las pruebas de embarazo en la selección y antes de la aleatorización.
    8. En el caso de mujeres, no ser fértiles (definiéndose este hecho como mujeres posmenopáusicas durante al menos 1 año o que se hayan sometido a esterilización quirúrgica [ligadura bilateral de trompas, ooforectomía bilateral o histerectomía]) o utilizar un anticonceptivo muy eficaz con una tasa de fracaso < 1 % según la Nota de orientación sobre estudios preclínicos de seguridad para la realización de ensayos clínicos en humanos y la tramitación de la autorización de comercialización para productos farmacéuticos (CPMP/ICH/286/95) de la Agencia Europea de Medicamentos (EMA).
    Los pacientes varones con parejas fértiles también deben confirmar un uso adecuado de anticonceptivos muy eficaces.
    9. Disposición y capacidad para cumplir con el protocolo.
    10. Disposición y capacidad de proporcionar un consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening.
    2. Cetuximab or other EGFR targeting agent treatment, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening.
    3. Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization.
    4. Concomitant anti-tumor therapy or concomitant immunotherapy.

    5. Concomitant corticosteroid treatment unless specified within the protocol.
    6. Clinical evidence of brain metastasis or leptomeningeal involvement.
    7. Patients with nasopharyngeal tumors.
    8. Concomitant malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g., basal cell cancer of the skin, cervical cancer or breast cancer in situ). Patients with previous malignancies but without evidence of disease for at least 5 years will be allowed to enter the study.
    9. Patients with renal or hepatic impairment (serum creatinine and bilirubin > 1.5 fold above the upper limit of normal ranges) and transaminase > 5 fold above the upper limit of normal ranges) and patients with hematology parameters outside the normal ranges (hemoglobin < 9 g/dl, absolute neutrophil count < 1500/mm3 and platelet count < 105/mm3) at screening.
    10. Clinically active infections ? Grade 2 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 and/or requiring intravenous antibiotics.
    11. Known active hepatitis B or C.
    12. Known human immunodeficiency virus (HIV) infection.
    13. Myocardial infarction within 6 months prior to screening.
    14. Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening.
    15. History of keratitis requiring medical interventions within the last 5 years.
    16. Patients with any other disorder that, in the opinion of the investigator, might interfere with the conduct of the study.
    17. Patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
    18. Patients institutionalized by official means or court order.
    19. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous CetuGEX? administration.
    20. Prior allergic reaction to a monoclonal antibody, grade 3 IRR or any grade 4 reaction to a monoclonal antibody.
    21. Known sensitivity to any component of the investigational medicinal product (IMP) and medication used in this study.
    1. Quimioterapia sistémica previa, excepto si se administró como parte de un tratamiento multimodal para enfermedad localmente avanzada que se completó más de 6 meses antes de la selección.
    2. Cetuximab u otro tratamiento con un agente dirigido al EGFR, excepto si se administró como parte de un tratamiento multimodal para enfermedad localmente avanzada que se completó más de 6 meses antes de la selección.
    3. Cirugía (salvo intervenciones menores como biopsia diagnóstica o implantación de un acceso intravenoso) o radioterapia en los 30 días anteriores a la aleatorización.
    4. Tratamiento antitumoral concomitante o inmunoterapia concomitante.
    5. Tratamiento concomitante con corticosteroides a menos que se especifique en el protocolo.
    6. Signos clínicos de metástasis cerebral o afectación leptomeníngea.
    7. Pacientes con tumores nasofaríngeos.
    8. Neoplasia maligna concomitante, excepto en caso de tumores tratados adecuadamente con una alta probabilidad de curación (p. ej.: cáncer basocelular de piel, cáncer de cuello uterino o cáncer de mama in situ). Los pacientes con neoplasias anteriores pero sin signos de enfermedad durante al menos 5 años podrán entrar en el estudio.
    9. Pacientes con deterioro renal o hepático (creatinina sérica y bilirrubina > 1,5 veces por encima del límite superior de los intervalos normales y transaminasa > 5 veces por encima del límite superior de los intervalos normales) y pacientes con parámetros hematológicos fuera de los intervalos normales (hemoglobina < 9 g/dl, recuento absoluto de neutrófilos < 1500/mm3 y cifra de plaquetas < 105/mm3) en la selección.
    10. Infecciones clínicamente activas de grado ? 2 según los Criterios de terminología comunes para acontecimientos adversos (CTCAE) del National Cancer Institute (NCI), versión 4, y/o que requieran antibióticos intravenosos.
    11. Hepatitis B o C activa conocida.
    12. Infección por el virus de la inmunodeficiencia humana (VIH).
    13. Infarto de miocardio en los 6 meses anteriores a la selección.
    14. Insuficiencia cardíaca congestiva sintomática (de grado 3 o 4 según la New York Heart Association [NYHA]), angina de pecho inestable en los 6 meses previos a la selección, arritmia cardiaca significativa, antecedentes de ictus o accidente isquémico transitorio en el año anterior a la selección.
    15. Antecedentes de queratitis que haya requerido intervenciones médicas en los últimos 5 años.
    16. Pacientes con cualquier otro trastorno que, en opinión del investigador, podría interferir en la realización del estudio.
    17. Pacientes con un proceso inestable (p. ej.: trastorno psiquiátrico, historial reciente de abuso de alcohol o drogas que interfiera en el cumplimiento del estudio, en los 6 meses previos a la selección) o que se consideren poco fiables o incapaces de cumplir los requisitos del protocolo.
    18. Pacientes ingresados en un hospital psiquiátrico con carácter oficial o por orden judicial.
    19. Pacientes que hayan recibido cualquier otro medicamento en investigación en los últimos 30 días antes de la aleatorización o cualquier administración previa de CetuGEX?.
    20. Reacción alérgica previa a un anticuerpo monoclonal, reacción relacionada con la infusión (RRI) de grado 3 o cualquier reacción de grado 4 a un anticuerpo monoclonal.
    21. Sensibilidad conocida a cualquiera de los componentes del producto en investigación (PEI) y a la medicación usada en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    progression-free survival
    Supervivencia libre de progresión (SLP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, every 6 weeks after day of randomization until Week 18 and every 8 weeks thereafter
    Visita de selección, cada 6 semanas después del día de la aleatorización hasta la semana 18, y, después, cada 8 semanas
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include:
    ? PFS as assessed by independent centralized reading according to modified irRC.
    ? Objective response rate (ORR, i.e., CR + PR) according to modified irRC at the end of combination treatment.
    ? Best overall response rates (CR, PR, SD) according to modified irRC including maintenance therapy treatment.
    ? Clinical benefit rate (CBR, i.e., CR + PR + SD) according to modified irRC.
    ? Overall survival (OS) defined as time from randomization until death of any cause.
    ? Time to treatment failure (TTF), as defined in Section 10.3.1.2.
    ? QoL scores assessed using EORTC-QLQ-C30 and EORTC-QLQ-H&N35H.
    In addition, PFS and all secondary efficacy endpoints listed above will be analyzed by Fc?RIIIa-allotype subgroups (i.e., FF, FV and VV), p16 status, and other potential parameters.
    Criterios secundarios de valoración
    Criterios de valoración de la eficacia:
    ? SLP, evaluada mediante una lectura centralizada independiente
    ? Tasa de respuesta objetiva (TRO; es decir, respuesta completa [RC] + Respuesta parcial [RP]) al final del tratamiento combinado
    ? Tasas de mejor respuesta global (incluido el periodo de tratamiento de mantenimiento)
    ? Tasa de beneficio clínico (TBC; es decir, RC + RP + enfermedad estable [EE])
    ? Duración de la respuesta
    ? Supervivencia global (SG)
    ? Tiempo hasta el fracaso del tratamiento (TFT)
    ? Las puntuaciones de CdV, evaluadas según los cuestionarios de calidad de vida (QLQ) del European Oncology Research Trials Committee (EORTC) EORTC-QLQ-C30 y EORTC-QLQ-H&N35.
    Además, la SLP y todos los criterios secundarios de valoración de la eficacia indicados anteriormente se analizarán por subgrupos de alotipos Fc?RIIIa (es decir, FF, FV, VV), por estado p16 y otros posibles parámetros.
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuously, see protocol
    Ver protocolo
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Spain
    Poland
    Romania
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    24 months after randomization of the last patient for assessment of overall survival
    24 meses después de la aleatorización del último paciente para la evaluación de la supervivencia global
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 240
    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)
    The patients will be treated until disease progression or intolerable toxicities.
    Los pacientes serán tratados hasta la progresión de la enfermedad o toxicidad limitante
    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 Decision2014-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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