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    Summary
    EudraCT Number:2006-001267-33
    Sponsor's Protocol Code Number:A6181107
    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:2010-04-07
    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 number2006-001267-33
    A.3Full title of the trial
    PHASE 3 RANDOMIZED, MULTI CENTER STUDY OF SUNITINIB MALATE (SU 011248) OR CAPECITABINE IN SUBJECTS WITH ADVANCED BREAST CANCER WHO FAILED BOTH A TAXANE AND AN ANTHRACYCLINE CHEMOTHERAPY REGIMEN OR FAILED WITH A TAXANE AND FOR WHOM FURTHER ANTHRACYCLINE THERAPY IS NOT INDICATED

    Estudio en fase 3, aleatorizado y multicéntrico de Malato de Sunitinib (SU 011248) o Capecitabina en pacientes con cáncer de mama avanzado que presentaron fracaso con un régimen de quimioterapia con un taxano y una antraciclina, o con un taxano y para quienes no está indicado el tratamiento con más antraciclinas
    A.4.1Sponsor's protocol code numberA6181107
    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 namesunitinib malate
    D.3.2Product code SU011248
    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
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU-0011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5 mg
    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 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 XELODA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameXeloda
    D.3.2Product code capecitabine
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNcapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 mg
    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 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 namesunitinib malate
    D.3.2Product code SU011248
    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
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU-0011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 mg
    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 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 namesunitinib malate
    D.3.2Product code SU011248
    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
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU-0011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 mg
    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 XELODA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameXeloda
    D.3.2Product code capecitabine.
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNcapecitabine
    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.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
    Diagnóstico confirmado desde el punto de vista histológico o citológico de adenocarcinoma de mama que no es susceptible de cirugía, radioterapia o tratamiento combinado con intención curativa.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006203
    E.1.2Term Breast cancer stage unspecified
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la supervivencia libre de progresión (SSP) de las pacientes con cáncer de mama avanzado tratadas con malato de sunitinib en una dosis inicial de 37,5 mg por vía oral una vez al día con la de capecitabina en una dosis de 1250 ó 1000 mg/m2 (en pacientes mayores de 65 años) dos veces al día durante 2 semanas consecutivas, seguidas de una semana de descaso en una pauta administrada en ciclos de 3 semanas.
    E.2.2Secondary objectives of the trial
    Evaluar
    • Tiempo hasta la progresión del tumor (TPT)
    • Respuesta global
    • Duración de la respuesta
    • Tiempo hasta la respuesta tumoral
    • Supervivencia global
    • Resultados comunicados por las pacientes (RCP)
    • Seguridad
    de malato de sunitinib a una dosis inicial de 37,5 mg por vía oral una vez al día y de capecitabina a una dosis de 1250 ó 1000 mg/m2 (en pacientes mayores de 65 años) dos veces al día durante 2 semanas consecutivas, seguidas de 1 semana de descaso en una pauta administrada en ciclos de 3 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Las pacientes deben cumplir todos los criterios de inclusión siguientes para poder participar en el ensayo:
    1. Diagnóstico confirmado desde el punto de vista histológico o citológico de adenocarcinoma de mama que no es susceptible de cirugía, radioterapia o tratamiento combinado con intención curativa.
    2. Enfermedad mensurable según los criterios RECIST. Las lesiones mensurables previamente irradiadas no se considerarán lesiones diana a menos que se haya observado un incremento de su tamaño tras la finalización de la radioterapia.
    3. El tumor debe ser negativo para HER 2 (puntuación de 0 o 1+ en la inmunotinción o negativos para FISH; ambas pruebas podrán sustituirse por la CISH en caso de aprobarse; si se realizó más de una prueba, se utilizarán los resultados de la FISH).
    4. Haber recibido tratamiento previo con una antraciclina y un taxano, bien simultánea o secuencialmente, como tratamiento neoadyuvante, adyuvante o de enfermedad avanzada. No se permitirán más de dos pautas de quimioterapia para la enfermedad avanzada.
    5. Haber recibido un ciclo adecuado de antraciclinas que se considere convencional para el tratamiento adyuvante o de la enfermedad metastásica, salvo que no esté indicado continuar con las antraciclinas. Está permitido el uso previo de tratamiento hormonal o inmunoterapia como adyuvante o para la enfermedad metastásica/avanzada. La inmunoterapia se debe suspender al menos 3 semanas antes del comienzo del tratamiento del estudio. El tratamiento hormonal deberá suspenderse antes del comienzo del tratamiento del estudio.
    6. Pueden haber recibido radioterapia previa. Una lesión mensurable previamente irradiada no se considerará lesión diana y sólo se evaluará cuando su tamaño aumente. La radioterapia deberá finalizar antes de las evaluaciones de la enfermedad realizadas en la selección.
    7. Mujeres mayores de 18 años. De conformidad con la enmienda n.º 4 (sólo para Japón), las pacientes menores de 20 años no se consideran adultas y necesitarán un representante legal que otorgue el consentimiento.
    8. Estado funcional (ECOG) de 0, 1 ó 2.
    9. Resolución de todos los efectos tóxicos agudos del tratamiento o los procedimientos quirúrgicos previos hasta el grado ≤1 (a excepción de la alopecia) o de otras toxicidades que no se consideren un riesgo para la seguridad de la paciente.
    10. Función orgánica adecuada según lo definido por los criterios siguientes:
    • Concentración de aspartato transaminasa (AST) y de alanina transaminasa (ALT) en suero ≤ 2,5 x límite superior de la normalidad (LSN), o AST y ALT ≤ 5 x LSN si las anomalías hepáticas se deben a la neoplasia maligna subyacente.
    • Bilirrubina total sérica ≤1,5 x LSN (pacientes con enfermedad de Gilbert con un valor de bilirrubina sérica total ≤2,5 x LSN)
    • Recuento absoluto de neutrófilos (RAN) :≥1500/µl
    • Plaquetas :≥ 100.000/µl
    • Hemoglobina ≥8,5 g/dl
    • Aclaramiento calculado de la creatinina >50 ml/min.
    • Albúmina sérica ≥ 2,5 g/dl
    • Creatinina sérica ≤1,5 x LSN
    • Fracción de eyección del ventrículo izquierdo (FEVI) ≥50% medida mediante ventriculografía isotópica en equilibrio (MUGA) o ecocardiograma (ECHO)
    11. Documento de consentimiento informado firmado y fechado en el que se indica que el paciente (o representante legal) ha sido informado de todos los aspectos pertinentes del estudio antes de su inclusión.
    12. Disposición y capacidad de cumplir las visitas programadas, los planes de tratamiento, los análisis de laboratorio y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    No serán incluidos en el ensayo los pacientes que presenten alguno de los siguientes criterios:
    Más de dos pautas de quimioterapia previas para enfermedad avanzada/metastásica y cualquier régimen previo con capecitabina.
    1. Cirugía mayor o tratamiento sistémico (excepto tratamiento hormonal) en las 3 semanas anteriores al primer tratamiento del estudio. Deben pasar al menos 7 días desde cualquier procedimiento quirúrgico menor, incluida la colocación de un dispositivo de acceso.
    2. Heridas no curadas completamente, úlceras activas o fracturas óseas.
    3. Tratamiento actual en otro ensayo clínico.
    4.Metástasis cerebrales, compresión de la médula espinal o meningitis carcinomatosa o enfermedad leptomeníngea.
    5. Lesiones óseas como única manifestación del cáncer de mama metastásico actual.
    6. Diagnóstico de una segunda neoplasia maligna en los últimos 3 años, a excepción del cáncer de mama previo, del cáncer basocelular o escamoso de piel debidamente tratado, o carcinoma in situ del cuello uterino.
    7. Cualquiera de los trastornos siguientes en los 6 meses previos al comienzo del tratamiento del estudio: infarto de miocardio, angina grave/inestable, insuficiencia cardiaca congestiva, accidente cerebrovascular incluido el accidente isquémico transitorio, embolia pulmonar, trombosis venosa profunda u otros episodios tromboembólicos significativos.
    8. Arritmias cardíacas en curso de grado ≥2 según los criterios CTCAE del NCI o intervalo QTc >470 ms para mujeres.
    9. Hipertensión que no se puede controlar con fármacos (>150/100 mmHg a pesar del tratamiento médico óptimo).
    10. Tratamiento actual con dosis terapéuticas de derivados de la cumarina o antagonistas de la vitamina K orales tales como warfarina y fenprocumón (se permiten dosis bajas para profilaxis de la trombosis venosa profunda). Si el paciente está recibiendo tratamiento con estos fármacos, habrá que vigilar el TP o el INR. Se permite el uso de heparina de bajo peso molecular en cualquier dosis.
    11. Infección conocida por el virus de la inmunodeficiencia humana, así como pacientes con infección activa por la hepatitis B y C. La infección activa se define como la necesidad de tratamiento.
    12. Pacientes embarazadas o lactantes. Mujeres en edad fértil que no quieran o no puedan usar anticonceptivos adecuados para evitar el embarazo durante el período del estudio y los 90 días posteriores a la última dosis del tratamiento del estudio. Todas las mujeres en edad fértil deberán dar resultado negativo en una prueba de embarazo (suero/orina) antes del primer día de tratamiento del estudio.
    13. Otras condiciones médicas o psiquiátricas graves, agudas o crónicas, o anomalías analíticas que pudieran implicar, en opinión del investigador, un riesgo excesivo asociado a la participación en el estudio o a la administración del fármaco del estudio, o que, a criterio del investigador, hicieran que el paciente no fuera candidato a participar en este estudio.
    14. Antecedentes de reacciones adversas graves e inesperadas al tratamiento con fluoropirimidina o hipersensibilidad conocida al 5-fluorouracilo o a la capecitabina o a cualquiera de los excipientes de la capecitabina.
    15. Carencia de dihidropirimidina deshidrogenasa conocida.
    16. Tratamiento actual con sorivudina o sus análogos relacionados químicamente, como la brivudina.
    17. Tratamiento previo con antiangiogénicos, como inhibidores tirosinquinasas (TKI) multidianas, entre ellos sorafenib o fármacos experimentales. Se permitirá el tratamiento previo con bevacizumab.
    18. Alteración tiroidea previa que impida mantener la función tiroidea en el intervalo normal.
    19. Tratamiento previo con TS-1 (tegafur/gimeracilo/oteracilo).
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresión (SSP), definida como el tiempo desde aleatorización hasta la primera documentación de progresión tumoral objetiva o hasta la muerte por cualquier causa, lo que ocurra antes.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Xeloda
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-04-07. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 700
    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)
    Seccion 6 del protocolo
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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