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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2006-004693-27
    Sponsor's Protocol Code Number:A6181064
    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:2010-03-04
    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 number2006-004693-27
    A.3Full title of the trial
    “ESTUDIO ALEATORIZADO FASE 3 DE DOCETAXEL EN COMBINACIÓN CON SUNITINIB VERSUS DOCETAXEL  EN EL TRATAMIENTO DE PRIMERA LÍNEA EN PACIENTES CON CÁNCER DE MAMA AVANZADO”

    "A RANDOMISED, PHASE 3 STUDY OF DOCETAXEL IN COMBINATION WITH SUNITINIB VERSUS DOCETAXEL IN THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER PATIENTS"
    A.4.1Sponsor's protocol code numberA6181064
    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 Yes
    D.2.1.1.1Trade name SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 nameSutent
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNsunitinib malate
    D.3.9.1CAS number 341031-54-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12.5 to 50
    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 Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for 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 1327-53-3.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 80
    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 Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 mama avanzado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que la combinación de docetaxel con sunitinib es superior al docetaxel solo prolongando la SLP en pacientes con cáncer de mama avanzado.
    E.2.2Secondary objectives of the trial
    • Comparar el beneficio clínico en pacientes tratadas con los 2 regímenes.
    • Comparar la seguridad de los 2 regímenes.
    • Comparar los resultados informados por las pacientes tratadas con los 2 regímenes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnóstico de cáncer de mama, comprobado histológica o citológicamente, con pruebas de 1) enfermedad recurrente localmente o no resecable, ó 2) enfermedad metastásica. La enfermedad localmente recurrente no debe ser susceptible de ser reseccionada o recibir radioterapia con intenciones curativas.
    2. Cáncer de mama Her-2 negativo (es decir, con FISH o CISH (si se aprueba) negativo o inmunohistoquímica de 0 ó +1).
    3. Enfermedad medible usando los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST, por sus siglas en inglés) o enfermedad sólo ósea.
    4. Serán elegibles los siguientes pacientes:
    • Pacientes no candidatos a quimioterapia adyuvante durante el diagnóstico inicial que recaigan con metástasis a distancia.
    • Pacientes candidatos a terapia hormonal adyuvante o neoadyuvante durante el diagnóstico inicial que recaigan con metástasis a distancia.
    • Pacientes candidatos a terapia citotóxica adyuvante o neoadyuvante durante el diagnóstico inicial que recaigan con enfermedad localmente avanzada o enfermedad metastásica.
    • Si la terapia adyuvante o neoadyuvante también incluía un taxano, la recaída debe haber tenido lugar ≥12 meses desde la compleción de la quimioterapia.
    • Se acepta la terapia hormonal concurrente o secuencial a la quimioterapia adyuvante.
    • La terapia hormonal para la enfermedad avanzada es aceptable, pero debe interrumpirse antes del inicio del tratamiento de estudio.
    • Los pacientes con enfermedad sólo ósea con receptor hormonal positivo deberán haber progresado durante o después de la terapia hormonal antes de su inclusión en el ensayo.
    5. Ser candidata para el tratamiento con docetaxel.
    6. Puede haber recibido radioterapia con anterioridad. Las lesiones medibles que hayan sido previamente irradiadas serán evaluadas sólo cuando crezcan en tamaño. Se completará la radioterapia antes de las evaluaciones de la enfermedad de selección.
    7. Mujeres de 18 años o mayores.
    8. Escala de estado funcional ECOG de 0 ó 1.
    9. Resolución de todos los efectos tóxicos agudos de las terapias anteriores o procedimientos quirúrgicos al grado ≤1 (excepto la alopecia u otras toxicidades no consideradas un riesgo para la seguridad del paciente).
    10. Funcionamiento adecuado de los órganos de acuerdo con los criterios siguientes:
    • Aspartato aminotransferasa (AST) en suero y alanina aminotransferasa (ALT) en suero ≤1,5 x límite superior de lo normal (LSN), o AST y ALT ≤2,5 x LSN en caso de anormalidades funcionales hepáticas debidas a tumores malignos subyacentes.
    • Bilirrubina total en suero <1 x LSN [Se permite incluir en el estudio a pacientes con enfermedad de Gilbert].
    • Albúmina en suero ≥2,5 g/dl.
    • Contaje absoluto de neutrófilos (CAN) ≥1500/µL.
    • Plaquetas ≥100.000/µL.
    • Hemoglobina ≥8,5 g/dl.
    • Creatinina en suero ≤1,5 x LSN.
    • Fracción de eyección del ventrículo izquierdo (FEVI) ≥50% medido o bien mediante el examen de ventriculografía nuclear (MUGA, por sus siglas en inglés) o por ecocardiografía (ECO).
    11. Documento del consentimiento informado firmado y fechado indicando que la paciente (o su representante legal aceptable) ha sido informada de todos los aspectos pertinentes del ensayo antes de ser incluida.
    12. Voluntad y capacidad para cumplir con las visitas del progbrazo, los planes de tratamiento, las pruebas de laboratorio y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    1. Presencia clínica de carcinoma inflamatorio sin ninguna otra enfermedad mensurable.
    2. Tratamiento previo con quimioterapia en la enfermedad metastásica.
    3. Pretratamiento previo en un ensayo clínico con sunitinib.
    4. Pacientes para las que el docetaxel esté contraindicado de acuerdo con la información de la prescripción local.
    5. Historial de reacciones de hipersensibilidad intensas al docetaxel o a otros fármacos formulados con polisorbato 80.
    6. AST y/o ALT > 1,5 x LSN concomitante con ALP > 2,5 x LSN.
    7. Cirugía mayor o terapia sistémica (a excepción del tratamiento hormonal) en las 3 semanas anteriores al inicio del tratamiento del estudio. Debe haber transcurrido al menos 1 semana desde la realización de procedimientos quirúrgicos menores, incluyendo la colocación de un dispositivo de acceso o una aspiración con aguja fina.
    8. Tratamiento en curso en otro ensayo clínico.
    9. Antecedentes o presencia de metástasis cerebrales, presencia de compresión de la médula espinal, meningitis carcinomatosa o enfermedad leptomeníngea.
    10. Diagnóstico de cualquier tumor maligno secundario en los últimos 3 años, exceptuando un carcinoma basocelular tratado adecuadamente o un cáncer de piel de las células espinales o un carcinoma in situ del cuello del útero.
    11. Cualquiera de los siguientes en los 6 meses anteriores al inicio del tratamiento del estudio: infarto de miocardio, angina intensa /inestable, fallo cardíaco congestivo, accidente cerebrovascular incluyendo el accidente isquémico transitorio o el émbolo pulmonar.
    12. Disritmias cardíacas en curso de grado >=2, o intervalo QTc >470 ms.
    13. Hipertensión que no puede controlarse con medicaciones (>150/100 mmHg a pesar de la terapia médica óptima).
    14. Tratamiento en curso con dosis terapéuticas de fármacos derivados cumarínicos, como warfarina o fenprocumon (se aceptan las dosis bajas para la profilaxis de la trombosis venosa profunda) o fármacos anti-vitamina K. Se permite el tratamiento con dosis terapéuticas de heparina de bajo peso molecular.
    15. Infección conocida por el virus de inmunodeficiencia humana.
    16. Embarazo o lactancia. Las pacientes embarazadas o lactantes, las mujeres potencialmente fértiles que no son capaces o no tienen intención de utilizar anticonceptivos para evitar el embarazo durante el ensayo y hasta 3 meses después de la última dosis de tratamiento de estudio. Todas las pacientes con potencial reproductivo deben proporcionar una prueba de embarazo negativa (suero u orina) antes de entrar en el estudio.
    17. Otras condiciones psiquiátricas, médicas crónicas o agudas intensas, o anormalidades de laboratorio que podrían conllevar, a juicio del investigador, un exceso de riesgo asociado con la participación en el estudio o la administración de los fármacos del estudio, o las anormalidades que, a juicio del investigador, podrían hacer que la paciente no fuera adecuada para entrar en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresión (SLP)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Resultados Informados por las Pacientes
    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 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) Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    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
    El final del ensayo en un estado miembro de la Unión Europea se define como el tiempo en el que se estima que se ha incluido suficientes pacientes y se ha completado el estudio de acuerdo con las estipulaciones reguladoras (p. ej., el Formulario de solicitud de Ensayo Clínico (CTA)) y la aplicación de la ética en el estado miembro.
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 550
    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)
    Se debe continuar evaluando a las pacientes durante 28 días de calendario después de la última dosis del fármaco del estudio (sunitinib y/o docetaxel). A las pacientes que interrumpan la administración de ambos fármacos antes de la PE se les seguirá para evaluación del tumor hasta que tenga lugar la PE, o hasta posterior terapia anticáncer en ausencia de una PE documentada, lo que ocurra primero.
    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 Decision2007-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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