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    Summary
    EudraCT Number:2011-001084-42
    Sponsor's Protocol Code Number:9090-08
    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:2011-07-12
    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 number2011-001084-42
    A.3Full title of the trial
    A Randomized, Phase IIb/III Study of Ganetespib (STA-9090) in Combination with Docetaxel versus Docetaxel alone in Subjects with Stage IIIb or IV Non-Small Cell Lung Cancer
    Estudio Aleatorizado de fase IIB/III de Ganetespib (STA-9090) combinado con docetaxel en comparación con docetaxel solo en pacientes con cáncer de pulmón no microcítico en estadios IIIB o IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effect of Ganetespib (study drug) in combination with Docetaxel versus Docetaxel alone in patients with advanced Non-Small Cell Lung Cancer
    Estudio para evaluar el efecto de ganetespib (medicamento del estudio) en combinación con docetaxel versus docetaxel solo en pacientes con cáncer de pulmón avanzado de células no pequeñas.
    A.4.1Sponsor's protocol code number9090-08
    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 SponsorSynta Pharmaceutical Corp.
    B.1.3.4CountryUnited States
    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 supportSynta Pharmaceutical Corp
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynta Pharmaceuticals
    B.5.2Functional name of contact pointAssociate Director
    B.5.3 Address:
    B.5.3.1Street Address45 Hartwell Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number001781541 7157
    B.5.5Fax number001781541 7103
    B.5.6E-mailjlufkin@syntapharma.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 nameganetespib
    D.3.2Product code STA-9090
    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 INNganetespib
    D.3.9.1CAS number 888216-25-9
    D.3.9.2Current sponsor codeSTA-9090
    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
    Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell 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
    Stage 1
    Evaluate progression free survival (PFS) in subjects with stage IIIB or IV NSCLC treated with the combination of ganetespib and docetaxel compared to docetaxel alone.

    Evaluate Overall Survival (OS) in subjects with high baseline serum levels of total LDH

    Stage 2
    Assess OS in subjects with stage IIIB or IV NSCLC treated with the combination of ganetespib and docetaxel compared to docetaxel alone
    Etapa 1
    Evaluar la supervivencia sin progresión (SSP) en sujetos con cáncer de pulmón no microcítico (CPNM) en estadio IIIB o IV tratados con la combinación de ganetespib y docetaxel en comparación con docetaxel solo.

    Evaluar la supervivencia global (SG) en sujetos con concentraciones séricas basales elevadas de lactato deshidrogenasa (LDH) total.

    Etapa 2
    Evaluar la SG en sujetos con CPNM en estadios IIIB o IV tratados con la combinación de ganetespib y docetaxel en comparación con docetaxel solo.
    E.2.2Secondary objectives of the trial
    Stage 1
    1. Compare the two treatment groups with respect to the following: overall response rate (ORR), clinical benefit rate (CBR), mean tumor size change, 1-year OS, and OS
    2. Determine the qualitative and quantitative toxicities associated with ganetespib administered in combination with docetaxel
    3. Determine the plasma drug concentrations at selected times of ganetespib and docetaxel in a subset of subjects
    4. Evaluate quality of life (QOL) status within the study population and compare the impact on QOL between treatment groups, using EORTC QLQ -C30 questionnaire

    Stage 2
    1. Compare the two treatment groups with respect to the following: PFS, ORR, CBR, mean tumor size change and 1-year OS
    2. Further characterize the safety of ganetespib in combination with docetaxel
    3. Evaluate QOL status within the study population and compare the impact on QOL between treatment groups, using EORTC QLQ -C30 questionnaire
    Etapa 1
    Comparar los dos grupos de tratamiento: tasa de respuesta global (TRG), tasa de beneficio clínico (TBC), cambio del tamaño tumoral medio, SG después de 1 año y SG.
    Determinar los efectos tóxicos cualitativos y cuantitativos de ganetespib + docetaxel.
    Determinar las concentraciones plasmáticas de ganetespib y docetaxel en un subgrupo.
    Evaluar la calidad de vida (CdV) en la población del estudio mediante el cuestionario EORTC QLQ-C30).

    Etapa 2
    Comparar los dos grupos de tratamiento en cuanto a los siguientes aspectos: SSP, TRO, TBC, cambio del tamaño tumoral medio y SG a 1 año.
    Caracterizar mejor la seguridad de ganetespib en combinación con docetaxel.
    Valorar la calidad de vida en la población del estudio y comparar el efecto en la CdV entre los grupos de tratamiento utilizando el cuestionario EORTC QLQ -C30.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18 years or older
    2. Pathologically confirmed diagnosis of NSCLC
    3. Stage IIIB or IV NSCLC
    4. ECOG Performance Status 0 or 1
    5. Prior therapy defined as:
    ? One prior systemic therapy for advanced disease that includes:
    i. A platinum-based chemotherapy; or
    ii. EGFR tyrosine kinase inhibitors (TKIs) in EGFR-mutated disease
    ? NOTE: Approved maintenance therapy (e.g., pemetrexed) is allowed provided that it was started no more than 4 weeks after the last dose of prior therapy for advanced disease. Prior adjuvant or neoadjuvant therapy for early stage disease is allowed
    ? NOTE: Previous anticancer treatment must have stopped at least 2 weeks prior to randomization
    6. Measurable disease by modified RECIST 1.1
    7. Radiologic evidence of disease progression following most recent prior treatment.
    Disease progression is defined as:
    ? Appearance of any new lesion or an increase of ? 20% of one or more existing lesions. Radiological scans from the subject?s most recent treatment must document the baseline or lowest tumor burden (nadir scans) and disease progression
    8. Subjects with CNS metastases are eligible, provided that the CNS metastases are radiologically and clinically stable and the subject has been off steroids after appropriate therapy for at least 3 months prior to randomization
    9. Adequate hematologic function defined as:
    ? Absolute neutrophil count (ANC) ? 1.5 × 109/L
    ? Hemoglobin ? 9 g/dL
    ? Platelets ? 100 × 109/L
    10. Adequate hepatic function defined as:
    ? Albumin ?3 g/dL
    ? Serum total bilirubin ?1.5 x ULN
    ? AST and ALT ?1.5 × ULN without liver metastases; ?5 × ULN if documented liver metastases
    11. Adequate renal function defined as
    ? Serum Creatinine ?1.5 mg/dL or calculated creatinine clearance (CLcr) per Cockgroft- Gault formula ? 60mL/min
    12. Negative serum pregnancy test at study entry for female subjects of childbearing potential
    13. Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 30 days after the last dose of study drug.
    14. Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    1.Varones o mujeres de 18 años o más.
    2.Diagnóstico de CPNM confirmado anatomopatológicamente.
    3.CPNM en estadio IIIB o IV.
    4.Estado funcional del ECOG de 0 o 1.
    5.Tratamiento previo definido como:
    • Un tratamiento sistémico previo para la enfermedad avanzada que incluye:
    i. Quimioterapia a base de platino, o bien
    ii. inhibidores de la tirosina cinasa del receptor del factor de crecimiento epidérmico (EGFR) (ITC) en enfermedades con mutación del EGFR.
    • NOTA: El tratamiento de mantenimiento aprobado (por ejemplo, pemetrexed) está permitido si no se había iniciado más de 4 semanas después de la última dosis del tratamiento previo para la enfermedad avanzada. Se permite el tratamiento adyuvante o neoadyuvante previo para las etapas iniciales de la enfermedad.
    • NOTA: El tratamiento antineoplásico previo debe haberse interrumpido al menos 2 semanas antes de la aleatorización.
    6.Enfermedad mensurable según los criterios RECIST 1.1 modificados.
    7.Signos radiológicos de progresión de la enfermedad después del tratamiento previo más reciente. La progresión de la enfermedad se define como:
    •Aparición de lesiones nuevas de cualquier tipo o un aumento ≥ 20% de una o más lesiones existentes. Las exploraciones radiológicas del tratamiento más reciente del sujeto deberán documentar la masa tumoral basal o mínima (exploraciones en el nivel mínimo) y la progresión de la enfermedad.
    8.Los sujetos con metástasis en el sistema nervioso central (SNC) podrán participar siempre que tales metástasis sean radiológica y clínicamente estables y que los sujetos hayan permanecido sin esteroides durante al menos 3 meses antes de la aleatorización después de un tratamiento adecuado.
    9.Función hematológica adecuada, definida como:
    a.Recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 109/l.
    b.Hemoglobina ≥ 9 g/dl.
    c.Plaquetas ≥ 100 x 109/l.
    10.Función hepática adecuada, definida como:
    a.Albúmina ≥ 3 g/dl.
    b.Bilirrubina total en suero ≤ 1,5 x LSN.
    c.Aspartato-aminotransferasa (AST) y alanina-aminotransferasa (ALT) ≤ 1,5 × LSN sin metástasis hepáticas o ≤ 5 × LSN si se documentan metástasis hepáticas.
    11.Función renal adecuada, definida como:
    a.Creatinina sérica ≤ 1,5 mg/dl o aclaramiento de creatinina calculado (CLcr) mediante la fórmula de Cockcroft-Gault ≥ 60 ml/min.
    12.Prueba de embarazo en suero negativa en el momento de la incorporación al estudio en las mujeres con capacidad reproductiva.
    13.Las mujeres con capacidad reproductiva y los varones deberán comprometerse a utilizar un método anticonceptivo adecuado (por ejemplo, hormonal o de barrera; abstinencia) durante todo el tratamiento y durante 30 días después de la última dosis del fármaco del estudio.
    14.Capacidad de comprender y voluntad de firmar un documento de consentimiento informado por escrito y de cumplir las visitas programadas, los planes de tratamiento, los análisis clínicos y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    1. Presence of active or untreated CNS metastases as determined by MRI or CT scan performed during screening.
    2. Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
    3. Serious cardiac illness or medical conditions including but not confined to:
    ? History of documented congestive heart failure (CHF), New York Heart Association
    class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor
    blockers, beta-blockers or diuretics. NOTE: Use of these medications for the treatment of hypertension is allowed
    ? Baseline QTc > 470 msec or history of QT prolongation while taking other medications
    ? Left ventricular ejection fraction (LVEF) < 50 % at baseline
    ? High-risk uncontrolled arrhythmias (ventricular tachycardia, high-Grade AV-block, supra-ventricular arrhythmias which are not adequately rate-controlled) that require current treatment with the following anti-arrythmic drugs: flecainide, moricizine or propafenone
    ? Current coronary artery disease with a history of myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
    Radiotherapy within 2 weeks prior to randomization (related toxicities must be ?Grade 1)
    5. Prior radiotherapy to the only area of measurable disease
    6. Major surgery (unrelated to NSCLC) within 4 weeks prior to randomization
    7. Hemoptysis ? Grade 2 at randomization
    8. Peripheral neuropathy ? Grade 2 at randomization
    9. History of severe allergic or hypersensitivity reactions to docetaxel or excipients (eg,
    polyethylene glycol [PEG] 300 and polysorbate 80)
    10. Women who are pregnant or lactating
    11. Significant weight loss of ? 10% body weight within the 4 weeks prior to randomization
    1.Presencia de metástasis activas o no tratadas en el SNC determinadas por resonancia magnética (RM) o tomografía computarizada (TC) realizadas en la selección.
    2.Tumores malignos activos distintos del CPNM en los 5 años previos con la excepción del carcinoma in situ del cuello del útero adecuadamente tratado o el carcinoma basocelular o epidermoide de la piel.
    3.Enfermedad cardíaca grave como, por ejemplo:
    • Antecedentes de insuficiencia cardíaca congestiva (ICC) documentada, de la clase II/III/IV de la New York Heart Association, con antecedentes de disnea, ortopnea o edema que precise tratamiento actual con inhibidores de la enzima convertidora de la angiotensina, antagonistas del receptor de la angiotensina II, betabloqueantes o diuréticos. NOTA: Se permite el uso de estos medicamentos para el tratamiento de la hipertensión.
    • QTc basal > 470 ms o antecedentes de prolongación del QT durante el tratamiento con otros medicamentos.
    • Fracción de eyección del ventrículo izquierdo (FEVI) < 50% en el momento basal.
    • Riesgo elevado de arritmias no controladas (taquicardia ventricular, bloqueo auriculoventricular de grado elevado, arritmias supraventriculares no suficientemente controladas por la frecuencia) que requieran tratamiento actual con los siguientes medicamentos antiarrítmicos: flecainida, moricizina o propafenona.
    • Enfermedad coronaria actual con antecedentes de infarto de miocardio, angina de pecho, angioplastia o cirugía de derivación coronaria.
    4.Radioterapia en las dos semanas previas a la aleatorización (los efectos tóxicos relacionados deben ser de grado ≤ 1).
    5.Radioterapia previa en la única zona de enfermedad mensurable.
    6.Cirugía mayor (no relacionada con el CPNM) en las 4 semanas previas a la aleatorización.
    7.Hemoptisis de grado ≥ 2 en el momento de la aleatorización.
    8.Neuropatía periférica de grado ≥ 2 en el momento de la aleatorización.
    9.Antecedentes de reacciones alérgicas o de hipersensibilidad intensas al docetaxel o a sus excipientes (por ejemplo, polietilenglicol [PEG] 300 y polisorbato 80).
    10.Mujeres embarazadas o lactantes.
    11.Pérdida considerable de peso ≥ 10% del peso corporal en las 4 semanas anteriores a la aleatorización.
    12.Enfermedad intercurrente no controlada como, entre otras cosas, reacción positiva para el virus de la inmunodeficiencia humana (VIH) en sujetos que están recibiendo tratamiento antirretroviral combinado, infección intensa o sistémica, arritmia ventricular o enfermedad psiquiátrica o situación social que limitarían el cumplimiento de los requisitos del estudio.
    13.Otros medicamentos o enfermedad médica o psiquiátrica grave, aguda o crónica, o cualquier anomalía de laboratorio que pueda aumentar el riesgo asociado a la participación en el ensayo o a la administración del fármaco del estudio o interferir en la interpretación de los resultados del estudio y, en opinión del investigador, impedir la participación en este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1
    The primary endpoints of the study are (1) PFS and (2) OS in a subset of subjects with high baseline serum LDH.

    Stage 2
    Evaluation of OS in the two treatment arms
    Etapa 1
    Los objetivos primarios del estudio son (1) supervivencia sin progresión (SSP) y (2) supervivencia global (SG) en sujetos con niveles basales altos de LDH.

    Etapa 2
    Evaluar la superivencia global (SG) en los 2 grupos de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage 1
    An administrative interim analysis of PFS for Stage 1 is planned when approximately 70% of events have occurred.The primary analysis of PFS for Stage 1 will be conducted when approximately 191 PFS events have been observed. The primary analysis of OS in subjects with high baseline LDH will be conducted when approximately 73 OS events have occurred.

    Stage 2
    A formal interim OS analysis is planned when approximately 125 OS events (approximately 40% of the total number of deaths) have been observed.
    The primary analysis for median OS will be conducted when approximately 311 OS events have been observed.
    Etapa 1
    Se ha previsto un análisis intermedio administrativo de la SSP en la etapa 1 cuando se hayan producido aproximadamente el 70% de los acontecimientos. El análisis principal de la SSP para la etapa 1 se realizará cuando se hayan observado aproximadamente 191 acontecimientos de SSP. El análisis principal de la SG en sujetos con LDH basal elevada se realizará cuando se hayan producido aproximadamente 73 acontecimientos de SG.

    Etapa 2
    Está previsto realizar un análisis intermedio formal de la SG cuando se hayan observado aproximadamente 125 acontecimientos de SG (aproximadamente el 40% del número total de muertes). El análisis principal de la mediana de la SG se realizará cuando se hayan observado aproximadamente 311 acontecimientos de SG.
    E.5.2Secondary end point(s)
    Stage 1
    Overall Response Rate, Clinical Benefit Rate, Mean tumour size changes, and 1 year overall survival and overall survival between the 2 treatment groups.
    Stage 2
    Progression Free Survival, Overall Response Rate, Clinical Benefit Rate, Mean tumour size changes, and 1 year overall survival and overall survival between the 2 treatment groups
    Etapa 1
    Tasa de respuesta global, tasa de beneficio clínico, cambio del tamaño tumoral medio, supervivencia global al año, y supervivencia global en los 2 grupos.
    Etapa 2
    Supervivencia sin progresión, tasa de respuesta global, tasa de beneficio clínico, cambio del tamaño tumoral medio, supervivencia global al año, y supervivencia global en los 2 grupos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stage 1 and Stage 2
    Mean tumor size changes from baseline to at least 6 and 12 weeks
    Clinical benefit is calculated by combining the rates of subjects with a best overall response of confirmed CR, PR and SD for at least 6 or 12 weeks, per modified RECIST 1.1
    Etapa 1 y 2
    cambio del tamaño tumoral medio desde el inicio del estudio hasta al menos 6 o 12 semanas. El beneficio clínico se calcula combinando las tasas de sujetos con una MRG de RC, RP y EE confirmadas durante al menos 6 o 12 semanas conforme a los criterios RECIST modificados 1.1.
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Medicamento en investigación en coadyuvancia con el tratamiento estándar
    IMP as an add-on to standard of care treatment
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bosnia and Herzegovina
    Canada
    Croatia
    Czech Republic
    Germany
    Hungary
    Netherlands
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Ukraine
    United Kingdom
    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
    End of trial is last survival follow-up which is approx 6 to 12 months after last patients' last visit
    El final del ensayo se define como el último contacto de supervivencia que se espera en aproximadamente entre 6 y 12 meses tras la última visita del último paciente.
    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 months4
    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 months4
    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.1.1Number of subjects for this age range: 0
    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: 444
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 296
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 410
    F.4.2.2In the whole clinical trial 740
    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)
    Patients should follow normal standard of care for treatment.
    Los pacientes deberán seguir la práctica clínica habitual.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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