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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-012504-13
    Sponsor's Protocol Code Number:A8081005
    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:2009-11-16
    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 number2009-012504-13
    A.3Full title of the trial
    “Estudio en fase 2, abierto, con un solo grupo de tratamiento, de la eficacia y seguridad de PF 02341066 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 2, OPEN-LABEL SINGLE ARM STUDY OF THE EFFICACY AND SAFETY OF PF 02341066 IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
    A.4.1Sponsor's protocol code numberA8081005
    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.3.9.2Current sponsor codePF-02341066
    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.3.9.2Current sponsor codePF-02341066
    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
    Evaluar la eficacia antitumoral del fármaco oral PF-02341066 mediante la tasa de respuesta objetiva (TRO), tras el fracaso de como mínimo una línea de quimioterapia en pacientes con NSCLC avanzado que presentan una translocación o inversión en el locus del gen ALK.
    E.2.2Secondary objectives of the trial
    # Evaluar las medidas secundarias de eficacia clínica, como duración de la respuesta (DR), tasa de control de la enfermedad (TCE) a las 6 y 12 semanas, supervivencia libre de progresión (SLP) y supervivencia global (SG) # Evaluar seguridad y tolerabilidad de PF-02341066 por vía oral # Determinar PK en esta población por métodos de PK poblacional (PKPO) y explorar correlaciones entre PK, respuesta y/o hallazgos de seguridad # Explorar la relación entre fusión génica ALK, presencia de proteína ALK y transcripción de la fusión # Correlacionar los cambios respecto a la basal de la expresión de biomarcadores en las rutas de señalización (incluyendo rutas JAK/STAT, MEK/ERK y PI3K/AKT) con la farmacocinética y las medidas de los resultados # Evaluar los resultados reportados por el paciente (RRP) en cuanto a calidad de vida relacionada con salud (HRQoL), síntomas relacionados con la enfermedad/trat.del cáncer de pulmón y el estado general de salud.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnóstico demostrado histológica o citológicamente de NSCLC localmente avanzado o metastásico.
    2. Positivo para translocación o inversión en el locus del gen ALK (p.ej., que resulte en una fusión EML4-ALK) según la prueba FISH con sondas de separación para ALK y definido como un aumento en la distancia entre las sondas ALK 5' y 3' o la pérdida de la sonda 5'.
    3. Cumplir uno de los criterios siguientes:
    • Paciente aleatorizado al Grupo B (pemetrexed o docetaxel) del estudio A8081007 al que se haya suspendido el tratamiento por progresión de la enfermedad definida según criterios RECIST versión 1.1 y determinada por una revisión radiológica independiente.
    • Paciente no elegible para el ensayo A8081007 debido a (1) tratamiento previo para la enfermedad avanzada con más de un régimen de quimioterapia, (2) tratamiento previo de la enfermedad avanzada con un solo régimen quimioterápico no basado en platino, (3) tratamiento previo con pemetrexed como parte de la quimioterapia basada en platino, no cumpliendo con los requisitos de elegibilidad para docetaxel del estudio A8081007 o (4) tratamiento con docetaxel como parte de la quimioterapia previa basada en platino, pero con un NSCLC que sea predominantemente un carcinoma de células escamosas y, por lo tanto, no candidato para ser tratado con pemetrexed.
    4. Los pacientes con metástasis cerebrales son elegibles si han sido tratados de forma adecuada y se encuentran neurológicamente estables durante un mínimo de 2 semanas, y además no estan recibiendo ninguna de las medicaciones contraindicadas en los Criterios de Exclusión nº 11-13.
    5. Cualquier tratamiento previo (quimioterapia, radioterapia o cirugía) debe haberse completado al menos 2 semanas antes de iniciar la medicación del estudio. Cualquier toxicidad aguda debe haberse recuperado hasta Grado menor/igual a 1 (a excepción de la alopecia).
    6. Los tumores deben ser medibles según los criterios RECIST (versión 1.1).
    7. Mujeres y hombres, de 18 o más años de edad.
    8. Estado funcional ECOG 0-2.
    9. Función orgánica adecuada, de acuerdo con los siguientes criterios:
    • Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) séricas menor/igual a 2,5 x límite superior de normalidad (LSN), o AST y ALT menor/igual a 5 x LSN si los trastornos de la función hepática se deben a la neoplasia de base
    • Bilirrubina sérica total menor/igual a 1,5 x LSN (excepto en los pacientes con enfermedad de Gilbert documentada)
    • Recuento absoluto de neutrófilos (RAN) mayor/igual a 1.500/µL
    • Plaquetas mayor/igual 100.000/µL
    • Hemoglobina mayor/igual a 9,0 g/dl
    • Creatinina sérica menor/igual a 1,5 x LSN
    10. Documento de consentimiento informado, firmado y fechado, que indique que el paciente (o su representante legal) ha sido informado de todos los aspectos pertinentes del ensayo antes de su inclusión.
    11. Disposición y capacidad para cumplir con las visitas programadas, los planes de tratamiento, los análisis de laboratorio y otros procedimientos del estudio, incluida la cumplimentación de las medidas de los RRP.
    E.4Principal exclusion criteria
    1. Elegibilidad para el protocolo A8081007.
    2. No haber recibido previamente quimioterapia para el NSCLC avanzado, o bien haber recibido erlotinib o gefitinib como único tratamiento previo para el NSCLC avanzado.
    3. Tratamiento actual en otro ensayo clínico terapéutico.
    4. Terapia previa específicamente dirigida contra ALK.
    5. Compresión de la médula espinal, meningitis carcinomatosa o enfermedad leptomeníngea.
    6. 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.
    7. Disritmias cardíacas activas de Grado NCI CTCAE mayor/igual 2, fibrilación auricular de cualquier grado o intervalo QTc >470 mseg
    8. Tratamiento previo con PF-02341066.
    9. Hipertensión que no pueda controlarse con medicamentos (>150/100 mmHg a pesar del tratamiento médico óptimo).
    10. Embarazo o lactancia.
    11. Uso de fármacos o alimentos que sean inhibidores potentes conocidos del CYP3A4, incluyendo pero no limitándose a amprenavir, atazanavir, claritromicina, delavirdina, diltiazem, eritromicina, indinavir, itraconazol, ketoconazol, miconazol, nefazodona, nelfinavir, ritonavir, saquinavir, telitromicina, troleandomicina, verapamil, voriconazol y el pomelo o el jugo de pomelo.
    12. Uso de fármacos que sean inductores potentes conocidos del CYP3A4 incluyendo pero no limitándose a carbamazepina, fenobarbital, fenitoína, rifabutina, rifampina, rifapentina, tipranavir, ritonavir y la hierba de San Juan.
    13. Uso de fármacos que sean sustratos del CYP3A4 con índice terapéutico estrecho, incluyendo pero no limitándose a aripiprazol, ergotamina, halofantrina, pimozida, triazolam, astemizol*, cisaprida* y terfenadina* (* retirados del mercado en EEUU).
    14. Neoplasias malignas previas (excepto el NSCLC actual): los pacientes no serán elegibles si presentan evidencias de neoplasia maligna activa (a excepción del cáncer cutáneo no-melanoma o el cáncer de cérvix in situ, o del cáncer de próstata localizado y presumiblemente curado con PSA < LSN) durante los últimos 5 años.
    15. Otras condiciones médicas o psiquiátricas graves, agudas o crónicas, o alteraciones analíticas que pudieran implicar, a juicio del investigador y/o del promotor, un riesgo excesivo asociado a la participación en el estudio o a la administración de los fármacos del mismo y que, en consecuencia, hagan que el paciente no sea adecuado para la inclusión en este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Criterio de valoración principal:
    • TRO
    Criterios de valoración secundarios:
    • DR, TCE a las 6 y 12 semanas, SLP, SG
    • Tipo, incidencia, severidad, gravedad y relación con las medicaciones del estudio de los acontecimientos adversos (AA) y las alteraciones de laboratorio
    • Concentraciones plasmáticas de PF-02341066
    • Tipos de variantes de fusión de EML4-ALK y expresión de la proteína ALK
    • Expresión proteica de biomarcadores identificados en muestras seriadas de tumor procedentes de cirugía o de biopsia, cuando se disponga de las mismas.
    • HRQoL, síntomas específicos del cáncer de pulmón y estado general de salud
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    Como se indica en el protocolo
    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)
    El protocolo no específica ningún cuidado post-tratamiento y el médico que trate a los pacientes 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 trial2015-12-29
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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