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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:2010-019390-15
    Sponsor's Protocol Code Number:EGF113333
    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:2010-10-21
    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 number2010-019390-15
    A.3Full title of the trial
    Estudio abierto y aleatorizado en fase II de lapatinib más quimioterapia comparado con
    trastuzumab más quimioterapia como tratamiento de primera línea de mujeres con cáncer de
    mama metastásico HER2-positivo y p95HER2-positivo.
    A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy versus Trastuzumab Plus Chemotherapy as Firstline Treatment for Women with HER2-positive and p95HER2-positive Metastatic Breast Cancer
    A.4.1Sponsor's protocol code numberEGF113333
    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 SponsorGlaxoSmithKline, 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 TYVERB 250 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXO GROUP LTD.
    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 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 INNLAPATINIB
    D.3.9.3Other descriptive nameLAPATINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 HERCEPTIN 150 mg polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 Powder and solvent 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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.3Other descriptive nameTRASTUZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Cáncer de mama metastásico HER2-positivo y p95HER2-positivo Breast Cancer; Breast Cancer (HER2-positive and p95HER2-positive metastatic
    breast cancer)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Cáncer metastásico de mama
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El criterio de valoración principal de este estudio es la supervivencia sin progresión y se define como el intervalo comprendido entre la fecha de aleatorización y la progresión de la enfermedad o la muerte por cualquier causa.
    E.2.2Secondary objectives of the trial
    - Evaluar la supervivencia global (SG) - Evaluar la tasa de respuesta global (TRG: respuesta completa
    [RC] o parcial [RP]) - Evaluar la tasa de respuesta clínica beneficiosa (TRCB: RC o RP en cualquier
    momento, o enfermedad estable [EE] >=24 semanas) Objetivos exploratorios: - Evaluar
    biomarcadores que se sabe que predicen la sensibilidad o la resistencia a lapatinib y trastuzumab (por
    ejemplo, mutaciones de PIK3CA o alteraciones de PTEN) y determinar su relación con la evolución
    clínica - Identificar biomarcadores derivados del tumor (ADN, ARN y proteínas) asociados a la
    evolución clínica - Evaluar biomarcadores derivados de la sangre asociados a la evolución clínica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Mujer >=18 años de edad 2. Cáncer de mama invasivo confirmado desde el punto de vista histológico
    o citológico con metástasis a distancia (designado como cáncer de mama metastásico o en estadio IV) -
    Diagnóstico de enfermedad en estadio IV o metastásica en el momento del diagnóstico primario o una
    recidiva 3. No haber recibido tratamiento sistémico o local previo (por ejemplo, quimioterapia,
    hormonoterapia o radioterapia) para tratar el cáncer de mama en estadio IV/metastásico - Se permite el
    tratamiento adyuvante o neoadyuvante previo 4. Documentación de la sobreexpresión de HER2 o la
    amplificación de su gen en el componente invasivo de la enfermedad metastásica o en el tumor
    primario, definido como: - 3+ mediante IHQ o - Amplificación del gen HER2/neu mediante hibridación
    in situ con fluorescencia, cromógena o en plata [FISH, CISH o SISH; >6 copias del gen HER2/neu por
    núcleo o un cociente entre las pruebas de FISH, CISH o SISH (copias del gen HER2 respecto a señales
    en el cromosoma 17) >=2,0] 5. Documentación por parte del laboratorio central de la expresión positiva
    de p95HER2 en el componente invasivo de la enfermedad metastásica (preferible) o en el tumor
    primario 6. Ausencia de antecedentes de metástasis en el SNC (incluida la afectación leptomeníngea) o
    metástasis estables en el SNC (definidas como asintomáticas y sin esteroides durante >=3 meses) 7.
    Fracción de eyección ventricular izquierda (FEVI) basal >=50% determinada mediante ecocardiograma
    (ECO) o ventriculografía isotópica en equilibrio (MUGA) 8. Recuperación o estabilización de todos los
    acontecimientos adversos asociados a los tratamientos antineoplásicos previos, incluida la radioterapia,
    en el momento de la selección 9. Estado funcional de 0-2 según el Eastern Cooperative Oncology Group
    (ECOG) 10. Función medular y orgánica adecuada según se define en el protocolo 11. Las mujeres en
    edad fértil, incluidas aquellas cuya última menstruación fue hace <12 meses (a menos que hayan sido
    esterilizadas por métodos quirúrgicos), deberán tener una prueba de embarazo en suero negativa y
    comprometerse a emplear un método anticonceptivo eficaz, como se define en la sección 7.4 del
    protocolo 12. Documento de consentimiento informado firmado
    E.4Principal exclusion criteria
    1. Antecedentes de otras neoplasias malignas. Excepción: podrán participar las que hayan permanecido
    sin enfermedad durante 5 años y aquellas con antecedentes de un cáncer de piel distinto del melanoma
    (basocelular o escamoso) totalmente resecado 2. Tratamiento antineoplásico simultáneo o tratamiento
    simultáneo con un fármaco en investigación 3. Administración de un fármaco en investigación en los 30
    días o el período correspondiente a 5 semividas, lo que suponga más tiempo, anteriores a la primera
    dosis del tratamiento del estudio 4. Tratamiento previo con anti-HER2, salvo trastuzumab o lapatinib (el
    tiempo transcurrido entre la última dosis de trastuzumab o lapatinib y la aleatorización debe ser >=3
    meses) 5. Cardiopatía grave, entre las que se incluyen las siguientes: - Arritmias no controladas -
    Angina de pecho no controlada o sintomática - Antecedentes de insuficiencia cardíaca congestiva (ICC)
    - Infarto de miocardio documentado <6 meses antes de la entrada en el estudio 6. Enfermedades
    hepáticas o biliares activas (a excepción de síndrome de Gilbert, colelitiasis asintomática, metástasis
    hepáticas o hepatopatía crónica estable según la evaluación de los investigadores) 7. Enfermedad o
    trastorno concomitante o cualquier proceso médico preexistente que, en opinión del investigador, pueda
    interferir con la seguridad de la paciente, la obtención del consentimiento informado o el cumplimiento
    de los procedimientos del estudio 8. Mujer embarazada o en período de lactancia 9. Toda anomalía
    digestiva con importancia clínica que podría alterar la absorción, como síndrome de malabsorción o
    resección importante del estómago o intestino (consúltese al monitor médico de GSK en caso de dudas
    sobre la elegibilidad) 10. Reacción de hipersensibilidad inmediata o diferida o idiosincrasia conocida a
    fármacos relacionados químicamente con alguno de los fármacos del estudio o con sus excipientes
    (véase la sección 5.1 del protocolo) que, en opinión del investigador, contraindica la participación
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de este estudio es la supervivencia sin progresión y se define como el intervalo comprendido entre la fecha de aleatorización y la progresión de la enfermedad o la muerte por cualquier causa.
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    lapatinib+quimioterapia v/s trastuzumab+quimioterapia. Quimioterapia: taxano o vinorelbina
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 No
    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 years5
    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 years5
    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 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 2010-10-21. 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 300
    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)
    Por favor, vease 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 Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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