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    Summary
    EudraCT Number:2011-005081-38
    Sponsor's Protocol Code Number:L00070IN309F0
    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:2012-06-11
    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 number2011-005081-38
    A.3Full title of the trial
    Phase III study of IV vinflunine in combination with methotrexate versus methotrexate alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck previously treated with platinum-based chemotherapy (study L00070 IN 309 F0)
    Estudio en fase III de vinflunina i.v. en combinación con metotrexato frente a metotrexato sólo en pacientes con cáncer de cabeza y cuello de células escamosas recurrente o metastásico previamente tratados con quimioterapia basada en platino (estudio L00070 IN 309 F0)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study of IV vinflunine in combination with methotrexate versus methotrexate alone in patients with recurrent or metastatic head and neck cancer previously treated with platinum-based chemotherapy
    Estudio de vinflunina i.v. en combinación con metotrexato frente a metotrexato sólo en pacientes con cáncer de cabeza y cuello recurrente o metastásico previamente tratados con quimioterapia basada en platino
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberL00070IN309F0
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE IBÉRICA, S.A.
    B.5.2Functional name of contact pointResponsable ensayos clínicos intern
    B.5.3 Address:
    B.5.3.1Street AddressBlue Building - Marina Village - Ramón Trías Fargas, 7-11
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08.005
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 934 833 049
    B.5.5Fax number+34 934 833 090
    B.5.6E-mailanabelen.paules@pierre-fabre.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name JAVLOR
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    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.3.1Product nameJAVLOR
    D.3.2Product code L0070
    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 INNVINFLUNINE
    D.3.9.1CAS number 162652-95-1
    D.3.9.2Current sponsor codeL00070
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.2.1.1.1Trade name Methotrexate Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMethotrexate Mylan
    D.3.4Pharmaceutical form Solution for injection
    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 INNmethotrexate
    D.3.9.1CAS number 59-05-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Methotrexate Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMethotrexate Mylan
    D.3.4Pharmaceutical form Solution for injection
    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 INNmethotrexate
    D.3.9.1CAS number 59-05-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    recurrent or metastatic squamous cell carcinoma of the head and neck previously treated with platinum-based chemotherapy
    cáncer de cabeza y cuello de células escamosas recurrente o metastásico previamente tratado con quimioterapia basada en platino
    E.1.1.1Medical condition in easily understood language
    recurrent or metastatic head and neck cancer
    cáncer de cabeza y cuello recurrente 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 17.0
    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
    to compare the overall survival (OS) of IV vinflunine in combination with methotrexate versus methotrexate alone in incurable recurrent / metastatic SCCHN patients who have failed platinum-based chemotherapy.
    comparar la supervivencia global (SG) de la vinflunina i.v. combinada con metotrexato frente al metotrexato sólo en pacientes con CCECC recurrente/metastásico incurable que han fracasado a la quimioterapia basada en platino.
    E.2.2Secondary objectives of the trial
    - to evaluate the response and disease control rate in the 2 study arms
    - to assess the response and disease control duration in the 2 study arms
    - to assess the progression-free survival in the 2 study arms
    - to assess the safety profile in both arms
    - to compare the change in disease-related symptoms in the 2 study arms by using the EORTC quality of life questionnaire
    - evaluar las tasas de respuesta y de control de la enfermedad en las 2 ramas del estudio
    - valorar la duración de la respuesta y del control de la enfermedad en las 2 ramas del estudio
    - valorar la supervivencia libre de progresión en las 2 ramas del estudio
    - valorar el perfil de seguridad en ambas ramas
    - comparar el cambio en los síntomas relacionados con la enfermedad en las 2 ramas del estudio utilizando el cuestionario de calidad de vida de la EORTC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must give written informed consent (personally signed and dated) before completing any study-related procedure
    2. Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
    3. Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative (cisplatin or carboplatin) that is not suitable for local therapy. Platinum-based chemotherapy can have been associated with cetuximab. Eligible patients include one of the following categories :
    - patients who have received induction chemotherapy (ICT) consisting of cisplatin plus 5-fluorouracil or docetaxel plus cisplatin plus 5-fluorouracil followed by radiotherapy alone or chemoradiation (CRT) or radiotherapy concomitant with cetuximab provided that recurrence occurs within 6 months of completing local therapy
    - patients who have completed cisplatin-based CRT with or without ICT provided that recurrence occurs within 6 months of completing local therapy. The minimum cumulative dose of cisplatin during CRT must be 200 mg/m².
    - patients with recurrent and/or metastatic SCCHN who relapse after platinum-based (cisplatin or carboplatin) chemotherapy given in firstline with an interval < 12 months
    - patients with metastatic SCCHN at diagnosis who have been treated with platinum-based (cisplatin or carboplatin) chemotherapy in firstline and relapse with an interval < 12 months. The definition of failure will be as follows :
    - refractory disease : progression during platinum-based regimen
    - resistant disease : progression during the time from completion of platinum-based chemotherapy but less than 6 months after its completion
    - other type of failure : progression > or = 6 months but < 12 months after completion of platinum-based chemotherapy
    4. No more than one prior chemotherapy regimen for recurrent/metastatic disease. Prior treatments with targeted therapy used in monotherapy are allowed
    5. Minimum interval of 4 weeks between the completion of first-line chemotherapy and randomisation
    6. Measurable or non measurable disease
    7. WHO performance status < or = 1
    8. Age >or = 18 years and < 80 years
    9. Adequate haematological function : absolute neutrophil count (ANC) > or = 1.5 x 109/L, platelets > or = 100 x 109/L, haemoglobin > or = 10g/dL.
    10. Adequate hepatic function : transaminases <or = 2.5 x Upper Limit of Normal (ULN), total bilirubin <or = 1.5 x ULN, alkaline phosphatase < or = 5 x ULN
    11. Adequate renal function : serum creatinine < or = ULN or calculated (Cockroft-Gault) creatinine clearance > 60 ml/min
    12. Women of childbearing potential must be using a medically accepted method of contraception (barrier methods, oral contraceptive, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration
    13. Fertile men must be using adequate contraceptive measures throughout the study period and for up to 3 months after the last dose of study treatment if their partners are women of childbearing potential
    14. The patient must have access to social insurance if applicable in the local regulations
    15. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, those conditions should be assessed with the patient before registration in the trial
    1. Los pacientes deben otorgar su consentimiento informado por escrito (firmado y fechado personalmente) antes de completar cualquier procedimiento relacionado con el estudio
    2. Carcinoma de células escamosas recurrente y/o metastásico confirmado histológica o citológicamente de la cavidad oral, orofaringe, hipofaringe o laringe
    3. Enfermedad progresiva documentada tras quimioterapia para CCECC locorregionalmente avanzado o recurrente/metastático, que incluyera un derivado del platino (cisplatino o carboplatino) que no sea adecuado para tratamiento local. La quimioterapia con platino puede haber estado asociada con cetuximab. Los pacientes elegibles han de pertenecer a una de las siguientes categorías:
    - pacientes que han recibido quimioterapia de inducción (QTI) consistente en cisplatino más 5-fluorouracilo o docetaxel más cisplatino más 5-fluorouracilo seguida de radioterapia sólo o quimiorradioterapia (QRT) o radioterapia concomitante con cetuximab siempre que la recidiva se produzca en los 6 meses posteriores a la finalización del tratamiento local
    - pacientes que han completado una QRT basada en cisplatino con o sin QTI siempre que la recidiva se produzca en los 6 meses posteriores a la finalización del tratamiento local. La dosis mínima acumulada de cisplatino durante la QRT debe ser 200 mg/m².
    - pacientes con CCECC recurrente y/o metastásico que tienen una recidiva después de la quimioterapia basada en platino (cisplatino o carboplatino) administrada en primera línea con un intervalo <12 meses- pacientes de CCECC metastásico en el momento del diagnóstico que han sido tratados con quimioterapia basada en platino (cisplatino o carboplatino) en primera línea y recidiva con un intervalo < 12 meses.

    La definición de fracaso es la siguiente:
    - enfermedad refractaria: progresión durante el régimen basado en platino
    - enfermedad resistente: progresión tras la finalización de la quimioterapia basada en platino pero antes de transcurrir 6 meses desde su finalización
    - u otro tipo de fracaso: progresión > o = 6 meses pero < 12 meses tras finalizar la quimioterapia basada en platino

    4. No más de un régimen de quimioterapia previo para enfermedad recurrente / metastásica. Se permiten tratamientos previos con terapia dirigida utilizada en monoterapia.

    5. Intervalo mínimo de 4 semanas entre la finalización de la quimioterapia de primera línea y la aleatorización

    6. Enfermedad mensurable o no mensurable

    7. Estado funcional de la OMS < o = 1

    8. Edad > o = 18 años y < 80 años

    9. Función hematológica adecuada: Recuento absoluto de neutrófilos (RAN) > o = 1,5 x 109/L, plaquetas > o = 100 x 109/L, hemoglobina > o = 10g/dL.

    10 . Función hepática adecuada: transaminasas < o = 2,5 x límite superior de normalidad (LSN), bilirrubina total < o = 1,5 x LSN, fosfatasa alcalina < o = 5 x LSN

    11. Función renal adecuada: creatinina sérica < o = LSN o cálculo del aclaramiento de la creatinina (Cockroft-Gault) > 60 ml/min
    12. Las mujeres en edad fértil deben utilizar un método anticonceptivo médicamente aceptado (método barrera, anticonceptivos orales, dispositivos intrauterinos) para evitar un embarazo durante los 2 meses anteriores al inicio del tratamiento del estudio, durante el período del estudio y hasta 3 meses después de la última dosis de tratamiento del estudio para minimizar el riesgo de embarazo. Las mujeres en edad fértil deben obtener un resultado negativo en el test de embarazo en suero o en orina en las 72 horas previas a la primera administración de tratamiento

    13. Los hombres en edad fértil deben utilizar unas medidas anticonceptivas adecuadas a lo largo del estudio y hasta los 3 meses después de la última dosis del tratamiento de estudio si sus parejas son mujeres en edad fértil

    14. El paciente debe tener acceso a la Seguridad Social si procede según la normativa local

    15. Ausencia de cualquier condición psicológica, familiar, sociológica o geográfica que pueda afectar al cumplimiento
    del protocolo del estudio y del programa de seguimiento, condiciones que deben ser evaluadas con el paciente antes del registro en el ensayo.

    E.4Principal exclusion criteria
    1. Nasopharyngeal carcinoma
    2. History of brain or leptomeningeal involvement
    3. History of other cancers except other synchronous head and neck squamous cell carcinomas, adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated with surgery and/or radiotherapy (with or without other anti-cancer therapy) and with no evidence of disease for at least 3 years
    4. Albumin level < 35 g/L
    5. Patients with weight loss >or = 5% within the last 3 months
    6. Recurrent pulmonary or upper airways infections (3 times or more in the last 3 months) requiring antibiotics and/or any infection requiring antibiotics within the last month before study entry
    7. Grade >or = 2 peripheral neuropathy at study entry according to NCICTC AE (version 3.0)
    8. Serum potassium < the lower limit of normal
    9. ECG demonstrating a QT/QTc interval > 480 msec
    10. A female is not eligible to enter the study if :
    . Pregnant or lactating
    . With positive pregnancy test at inclusion
    11. Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment
    Male unwilling or unable to use a medically accepted method to avoid pregnancy throughout the study period and at least 3 months following the last dose of study treatment if their partners are women of childbearing potential.
    12. Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e. active serious infection, poorly controlled diabetes mellitus, concurrent heart failure [New York Heart Association (NYHA) class III-IV] or with progressive or unstable angina, myocardial infarction within 6 months, and/or poorly controlled hypertension.
    13. Third space fluids (pleural effusion, ascites, massive edema)
    14. Concomitant treatment with any other anti-cancer therapy and contraindicated medication (see Section 6.1
    15. Prior treatment with vinca-alkaloids and methotrexate
    16. Participation into a clinical study of an investigational agent within 30 days before study entry
    1. Carcinoma nasofaríngeo
    2. Antecedentes de afectación cerebral o leptomeníngea
    3. Antecedentes de otros cánceres excepto otros carcinomas sincrónicos de cabeza y cuello de células escamosas, carcinoma de cuello uterino in situ y carcinoma de las células escamosas o basales de la piel tratados adecuadamente u otro cáncer tratado de forma curativa con cirugía y/o radioterapia (con o sin otra terapia contra el cáncer) y sin indicios de enfermedad durante al menos 3 años.
    4. Nivel de Albúmina < 35 g/L
    5. Pacientes con pérdida de peso > o = 5% en los 3 últimos meses.
    6. Infecciones recurrentes pulmonares o de vías respiratorias altas (3 veces o más en los últimos 3 meses) que hayan requerido antibióticos y/o cualquier infección que haya requerido antibióticos dentro del último mes antes de su entrada en el estudio.
    7. Neuropatía periférica de grado > o = 2 a la entrada en el estudio de acuerdo con NCI-CTC AE (versión 3.0)
    8. Potasio sérico < límite inferior de la normalidad
    9. Electrocardiograma que indica un intervalo QT/QTc > 480 ms
    10. Una mujer no será elegible para el estudio si:
    . está embarazada o en período de lactancia
    . presenta un resultado positivo en el test de embarazo en el momento de la inclusión
    11. Mujeres en edad fértil que no desean o no pueden utilizar un método médicamente aceptado para evitar el embarazo durante los 2 meses anteriores al inicio del tratamiento del estudio, durante el período del estudio y al menos hasta 3 meses después de la última dosis del tratamiento del estudio.
    Hombres que no desean o no pueden utilizar un método médicamente aceptado para evitar el embarazo a lo largo del estudio y hasta al menos los 3 meses después de la última dosis del tratamiento de estudio si sus parejas son mujeres en edad fértil.
    12. Pacientes con cualquier dolencia subyacente que pueda verse agravada por el tratamiento o que no pueda ser controlada p. ej., infección grave activa, diabetes mellitus mal controlada, insuficiencia cardiaca concomitante [New York Heart Association (NYHA) clase III-IV] o con angina progresiva o inestable, infarto de miocardio en los últimos 6 meses, y/o hipertensión mal controlada.
    13. Líquidos del tercer espacio (derrrame pleural, ascitis, edema masivo)
    14. Tratamiento concomitante con cualquier otro tratamiento oncológico y con medicación contraindicada (ver Sección 6.1
    15. Tratamiento previo con alcaloides de la vinca y metotrexato
    16. Participación en un estudio clínico de un agente en fase de investigación en los 30 días previos al ingreso en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    overall survival
    supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    overall survival is defined as time from randomisation to death or last follow-up
    la supervivencia global se define como el tiempo desde la aleatorización hasta la muerte o el último seguimiento
    E.5.2Secondary end point(s)
    - response and disease control rate
    - response and disease control duration
    - progression-free survival
    - safety profile
    - to compare the change in disease-related symptoms
    - tasas de respuesta y de control de la enfermedad
    - duracion de la respuesta y del control de la enfermedad
    - supervivencia libre de progresión
    - perfil de seguridad
    - comparar el cambio en los síntomas relacionados con la enfermedad
    E.5.2.1Timepoint(s) of evaluation of this end point
    efficacy and quality of life: every 6 weeks
    safety : day 1 of each cycle and every 6 weeks
    demographic data: day 1 of each cycle
    eficacia y calidad de vida: cada 6 semanas
    seguridad: día 1 de cada ciclo y cada 6 semanas
    demografía: día 1 de cada ciclo
    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 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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    Belarus
    Belgium
    Brazil
    Estonia
    France
    Germany
    Italy
    Lithuania
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Taiwan
    Ukraine
    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
    The end of study is defined as the date of the last death observed in the study. Patients will be followed every month after documentation of progression during the first 6 months and then every 3 months until death.
    El fin del estudio se define como la fecha de última muerte observada en el estudio. A los pacientes se les realizará un seguimiento cada mes tras haberse documentado la progresión durante los 6 primeros meses y después cada 3 meses hasta la muerte.
    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 months6
    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 months6
    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: 530
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 530
    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 state174
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 281
    F.4.2.2In the whole clinical trial 530
    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)
    see protocol
    véase el protocolo
    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 Decision2014-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-23
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