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    Summary
    EudraCT Number:2009-012595-27
    Sponsor's Protocol Code Number:A8081007
    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:2009-11-17
    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 number2009-012595-27
    A.3Full title of the trial
    “Estudio en fase 3, aleatorizado y abierto, de la eficacia y seguridad de PF-02341066 frente a quimioterapia estándar (pemetrexed o docetaxel) en pacientes con cáncer de pulmón no microcítico (NSCLC) avanzado que presentan una translocación o inversión en el locus del gen de la quinasa de linfoma anaplásico (ALK)”

    PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF PF-02341066 VERSUS STANDARD OF CARE CHEMOTHERAPY (PEMETREXED OR DOCETAXEL) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
    A.4.1Sponsor's protocol code numberA8081007
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer, S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameNot Applicable
    D.3.2Product code PF-02341066
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameIUPAC: (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameNot Applicable
    D.3.2Product code PF-02341066
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameIUPAC: (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 ALIMTA 500 mg polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPEMETREXED
    D.3.9.3Other descriptive namePEMETREXED
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 4
    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 TAXOTERE 80 mg concentrado y disolvente para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderAVENTIS PHARMA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 5
    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 TAXOTERE 20 mg concentrado y disolvente para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderAVENTIS PHARMA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 6
    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 ALIMTA 100 mg polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPEMETREXED
    D.3.9.3Other descriptive namePEMETREXED
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    "CANCER DE PULMON NO MICROCÍTICO (NSCLC) AVANZADO QUE PRESENTA UNA TRANSLOCACIÓN O INVERSIÓN EN EL LOCUS DEL GEN DE LA QUINASA DE LINFOMA ANAPLÁSICO (ALK)"

    ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo primario:
    • Demostrar que PF-02341066 (Grupo A) es superior a la quimioterapia estándar, pemetrexed o docetaxel (Grupo B), en cuanto a la prolongación de la SLP en los pacientes con NSCLC avanzado cuyos tumores presentan una translocación o inversión en el locus del gen ALK y que han recibido sólo un régimen de quimioterapia previo para el NSCLC avanzado y dicho régimen estaba basado en platino.
    E.2.2Secondary objectives of the trial
    Objetivos secundarios:
    # Evaluar medidas secundarias de eficacia clínica, como tasa de respuesta objetiva (TRO), duración de la respuesta (DR), tasa de control de la enfermedad (TCE) a las 6 y 12 semanas, y supervivencia global (SG) en ambos grupos de trat.# Evaluar seguridad y tolerabilidad de PF-02341066 vs pemetrexed o docetaxel # Comparar los resultados reportados por paciente (RRP) en cuanto a calidad de vida relacionada con salud (HRQoL), síntomas relacionados con enfermedad/trat. del cáncer de pulmón y estado general de salud en ambos grupos de trat. # Caracterizar los efectos de PF-02341066 a dosis terapéuticas sobre QTc en esta población # Determinar PK en esta población por métodos de PK poblacional y explorar correlaciones entre PK, respuesta y/o hallazgos de seguridad. # Explorar la relación entre fusión del gen ALK, proteína ALK y transcripción de la fusión # Correlacionar modulación de biomarcadores solubles con PK y medidas de los resultados
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subestudios ECG y MUGA - No hay un titulo, fecha o versión para los sub-estudios. Un subgrupo de pacientes del protocolo participaran en los subestudios. Objetivo ECG: Caracterizar los efectos de PF-02341066 sobre el intervalo QTc. Sólo se realizará en 10 centros del mundo (pendiente confirmar si participara España) Objetivo del subestudio MUGA: Ayudar a evaluar la seguridad de PF-02341066 vs quimioterpia estándar. Es muy probable que sólo participe Estados Unidos.
    E.3Principal inclusion criteria
    1. Diagnóstico histológico o citológico de NSCLC localmente avanzado o metastásico # 2.Positivo para translocación o inversión en el locus del gen ALK según la prueba FISH con sondas de separación para ALK y definido como aumento en la distancia entre sondas ALK 5’ y 3’ o pérdida de sonda 5’. # 3. Progresión de la enf. después de 1 solo régimen quimioterapia previo basado en platino (puede incluir terapia de mantenimiento). Los pacientes deben ser candidatos para recibir pemetrexed o docetaxel. Incluye: Pacientes que recibieron un régimen de quimioterapia previo basado en platino para el trat.NSCLC de novo Estadío IIIB/IV / Pacientes que recibieron un régimen de quimioterapia previo basado en platino como trat. adyuvante tras la resección quirúrgica de la enf. temprana y cuya enf. ha reaparecido en los 6 meses tras finalización de quimioterapia previa / Pacientes que recibieron un régimen de quimioterapia previo basado en platino en combinación con radioterapia para enf. locorregional en Estadío III, y cuya enf. ha reaparecido en los 6 meses tras finalización de quimioterapia previa / Pacientes que recibieron 2 regimenes de quimioterapia previos basados en platino, siempre que el 1er régimen fuese trat. adyuvante o en combinación con radioterapia para la enf. localmente avanzada / Pacientes que han recibido trat. previo con un inhibidor de tirosín quinasa del EGFR, como erlotinib o gefitinib, si han recibido un solo régimen de quimioterapia previo basado en platino en uno de los supuestos anteriores # 4. Pacientes con metástasis cerebrales si han sido tratadas y estan estables durante un mínimo de 2 semanas, y no estan recibiendo ninguna medicación contraindicada (Criterios Exclusión 11-12). # 5. Cualquier quimioterapia previa o cirugía mayor debe completarse al menos 4 semanas antes de la medicación del estudio. Las irradiaciones y los procedimientos de cirugía menor previos deben completarse al menos 2 semanas antes de la medicación del estudio. Cualquier toxicidad aguda recuperada a grado menor/igual 1 ( excepto alopecia) # 6. Los tumores deben ser medibles según los criterios RECIST. Según Nota de Archivo del equipo Internacional (fecha: 24.Ago.2009) se utilizarán finalmente los criterios RECIST versión 1.1. en lugar de version 1.0. # 7. Mujeres y hombres, de 18 o más años. # 8. Estado funcional ECOG 0-2. # 9. Función orgánica adecuada: Función hepática: AST) y ALT séricas menor/igual 2,5 x LSN, o AST y ALT menor/igual 5 x LSN si los trastornos de la función hepática se deben a la neoplasia de base; sin embargo, para los pacientes que asignados aleatoriamente al Grupo B deban recibir docetaxel, ALT y/o AST no deben ser mayor 1,5 x LSN con una fosfatasa alcalina mayor 2,5 x LSN. Bilirrubina sérica total menor/igual 1,5 x LSN (excepto con enfermedad de Gilbert; sin embargo, para los pacientes que asignados aleatoriamente al Grupo B, deban recibir docetaxel, la bilirrubina sérica total debe ser menor/igual 1 x LSN. Función de la médula ósea: Recuento absoluto de neutrófilos (RAN) mayor/igual 1500/µL. Plaquetas mayor/igual 100,000/µL. Hemoglobina mayor/igual 9.0 g/dL. Función renal: Aclaramiento de la creatinina (fórmula modificada Cockcroft-Gault) mayor/igual 45 ml/min. # 10. Consentimiento informado, firmado y fechado, que indique que el paciente (o su representante legal) ha sido informado de todos los aspectos del ensayo antes de su inclusión. # 11. Disposición y capacidad para cumplir con las visitas programadas, análisis etc.. y otros procedimientos del estudio, incluida la cumplimentación de las medidas de los RRP
    E.4Principal exclusion criteria
    1. Tratamiento actual en otro ensayo clínico. # 2. Terapia previa dirigida contra ALK. # 3. Compresión de la médula espinal, meningitis carcinomatosa o enfermedad leptomeníngea. # 4. Cualquiera de los siguientes trastornos en los 6 meses previos al inicio del tratamiento del estudio: infarto de miocardio, angina grave/inestable, cirugía de bypass de arteria coronaria/periférica, insuficiencia cardiaca congestiva o accidente cerebrovascular incluido el accidente isquémico transitorio. # 5. Disritmias cardíacas activas de grado NCI CTCAE mayor/igual 2, fibrilación auricular de cualquier grado o intervalo QTc mayor 470 mseg. # 6. Tratamiento previo con PF-02341066. # 7. Pacientes que, si aleatorizados al Grupo B, deban recibir pemetrexed y presenten NSCLC que sea carcinoma de células escamosas. # 8. Pacientes que, si aleatorizados al Grupo B, deban recibir docetaxel y presenten neuropatía periférica de Grado mayor 2 (CTCAE versión 3.0). # 9. Pacientes que, si aleatorizados al Grupo B, deban recibir docetaxel y estén tratados con medicaciones conc. con polisorbato 80. # 10. Hipertensión no controlada con medicamentos (mayor 150/100 mmHg). # 11. Embarazo o lactancia. # 12. Uso de fármacos o alimentos que sean inhibidores potentes del CYP3A4 por ej. amprenavir, atazanavir, claritromicina, delavirdina, diltiazem, eritromicina, indinavir, itraconazol, ketoconazol, miconazol, nefazodona, nelfinavir, ritonavir, saquinavir, telitromicina, troleandomicina, verapamil, voriconazol, pomelo o el jugo de pomelo. # 13. Uso de fármacos que sean inductores potentes del CYP3A4 por ej. carbamazepina, fenobarbital, fenitoína, rifabutina, rifampina, rifapentina, tipranavir, ritonavir y la hierba de San Juan. # 14. Uso de fármacos que sean sustratos del CYP3A4 con índice terapéutico estrecho, por ej. aripiprazol, ergotamina, halofantrina, pimozida, triazolam, astemizol, cisaprida y terfenadina. # 15. Neoplasias malignas previas (excepto el NSCLC actual): no serán elegibles si hay evidencias de neoplasia maligna activa (a excepción del cáncer cutáneo no-melanoma o cáncer de cérvix in situ, o cáncer de próstata localizado y curado con PSA < LSN) durante los últimos 5 años. # 16. Otras condiciciones médicas o psiquiátricas graves, agudas o crónicas, o alteraciones analíticas que a juicio del investigador y/o del promotor, fueran un riesgo excesivo para la participación en el estudio o a la administración de los fármacos del mismo y que hagan que el paciente no sea adecuado para este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Criterio de valoración principal:
    • SLP basada en los criterios RECIST versión 1.0 * (confirmada por una revisión radiológica independiente)
    * Según Nota de Archivo proporcionada por el equipo Internacional (fecha: 24.Ago.2009) se utilizarán finalmente los criterios RECIST versión 1.1. en lugar de version 1.0.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned11
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    De acuerdo con el apartado 13.1 del protocolo, el fin del estudio se define como la fecha en la que se considera que se han reclutado y han completado el estudio suficientes pacientes
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 318
    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)
    Los pacientes en el grupo B (quimioterapia estándar) podrán entrar en el estudio A8081005 para tener acceso al PF-02341066 si cumplen los criterios de inclusión/exclusión para dicho estudio. Para los pacientes del grupo A (PF-02341066) el protocolo no específica ningún cuidado post-tratamiento y el médico que les trate será quien decida su siguiente linea de tratamiento
    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 Decision2010-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-05
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