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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2005-003926-24
    Sponsor's Protocol Code Number:EGF104900
    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:2005-12-28
    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 number2005-003926-24
    A.3Full title of the trial
    "Estudio fase 3, aleatorizado, abierto, multicéntrico, de lapatinib en combinación con trastuzumab vs lapatinib en monoterapia en sujetos con cáncer de mama metastásico cuyo tumor ha progresado durante el tratamiento con un régimen que contenia trastuzumab"

    A randomized, multicentre, open-label Phase III study of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with metastatic breast cancer whose disease has progressed on trastuzumab-containing regimens
    A.4.1Sponsor's protocol code numberEGF104900
    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 Information not present in EudraCT
    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 namelapatinib
    D.3.2Product code GW572016
    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.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd., UK
    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.3.1Product nametrastuzumab
    D.3.4Pharmaceutical form Powder 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.3.10 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar y comparar la actividad antitumoral, en términos de supervivencia sin progresión, de trastuzumab más lapatinib frente a lapatinib en monoterapia en pacientes con cáncer de mama metastásico con amplificación del ErbB2.
    E.2.2Secondary objectives of the trial
    • Evaluar y comparar los dos grupos de tratamiento con respecto a lo siguiente: supervivencia global, tasa de respuesta tumoral, beneficio clínico, tiempo hasta la respuesta y duración de la respuesta.
    • Determinar la toxicidad cualitativa y cuantitativa asociada a lapatinib oral administrado diariamente en combinación con trastuzumab frente a monoterapia con lapatinib.
    • Recoger y guardar muestras de suero para comparar las concentraciones séricas basales y durante el tratamiento de los DEC de ErbB1 y ErbB2, • Caracterizar la población de pacientes mediante la determinación de la expresión intratumoral de ErbB1, ErbB2 y biomarcadores que estén por debajo de los mismos en la cascada de señalización intracelular
    • Evaluar la calidad de vida (QOL) en la población del estudio y comparar el impacto sobre la QOL entre los grupos de tratamiento.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Consentimiento informado firmado.
    2. Mujeres > 18 años.
    3. Cáncer de mama metastásico, confirmado histológica o citológicamente.
    • Si la enfermedad está restringida a una sola lesión, su naturaleza neoplásica se deberá confirmar mediante citología o histología.
    4. Las pacientes deben presentar cáncer de mama de estadio IV, ya sea porque su enfermedad haya progresado durante el tratamiento adyuvante o metastásico. Los tratamientos previos deben incluir, pero no se limitan a:
    • Régimen que contiene taxanos durante al menos 4 ciclos, o 2 ciclos siempre que la progresión de la enfermedad se produzca durante el tratamiento con taxano.
    • Régimen que contiene antraciclinas durante al menos 4 ciclos, o 2 ciclos siempre que la progresión de la enfermedad se produzca durante el tratamiento con antraciclina.
    5. Las pacientes deben haber recibido y haber progresado después del tratamiento con al menos DOS regimenes de trastuzumab más quimioterapia citotóxica para la enfermedad metastásica. Las quimioterapias citotóxicas que se administran habitualmente con trastuzumab son taxanos, vinorelbina, gemcitabina o capecitabina. El tratamiento más reciente debe haber contenido trastuzumab, en monoterapia o en combinación con otra quimioterapia, durante al menos 6 semanas de dosis estándar en el estado metastásico, y las pacientes deben haber progresado durante dicho régimen. Trastuzumab administrado como adyuvante no es excluyente, pero para efectos de elegibilidad, trastuzumab también debe haber sido administrado durante la enfermedad metastásica.
    6. Las pacientes deben tener disponible una muestra de tejido del tumor archivada para su evaluación.
    7. Amplificación documentada del gen ErbB2 por hibridación in situ de fluorescencia (FISH) en el tejido tumoral primario o metastásico. La amplificación puede estar documentada por un laboratorio local o por el laboratorio central para la aleatorización de la paciente en el estudio. Además, se debe enviar una muestra de tejido al laboratorio central antes de que la paciente sea incluida en el estudio.
    8. Lesiones mensurables de acuerdo a los criterios RECIST (Criterios de evaluación de la respuesta en tumores sólidos) [Therasse, 2000].
    9. Pacientes con metástasis del SNC estables definidas como asintomáticas y sin tratamiento con antiepilépticos y esteroides sistémicos durante un mínimo de 3 meses.
    10. Se permite la radioterapia en las 2 semanas previas al inicio de la administración del producto en investigación para un área limitada (por ejemplo, tratamiento paliativo para la enfermedad con dolor) siempre que no sea el lugar de enfermedad mensurable; no obstante, la paciente debe haber completado el tratamiento y haberse recuperado de todas las toxicidades relacionadas con el tratamiento radioterápico antes de la administración de la primera dosis de producto en investigación.
    11. A excepción del tratamiento previo con trastuzumab, deben haber transcurrido al menos 3 semanas desde el último tratamiento con quimioterapia, inmunoterapia, terapia biológica, terapia hormonal para el cáncer, o cirugía (salvo procedimientos quirúrgicos menores) antes del comienzo de la administración del producto en investigación. Las pacientes se deben haber recuperado o estabilizado suficientemente de las toxicidades relacionadas con el tratamiento antes de la administración de la primera dosis del producto en investigación.
    12. Se permite el tratamiento con bifosfonatos para las metástasis óseas; no obstante, el tratamiento se debe iniciar antes de la primera dosis del producto en investigación. La utilización profiláctica de bifosfonatos se permite únicamente para el tratamiento de la osteoporosis.
    13. Estado funcional de la ECOG de 0 ó 1.
    14. Capaz de tragar y mantener la medicación oral.
    15. Fracción de eyección cardiaca dentro del rango de normalidad de la institución determinada por ecocardiograma. Se aceptarán pruebas radiológicas MUGA en los casos en los que no se pueda realizar un ecocardiograma o éste no sea concluyente.
    16. La paciente debe tener una función orgánica adecuada según se define en el protocolo
    E.4Principal exclusion criteria
    1. Mujeres embarazadas o en periodo de lactancia.
    2. Tratamiento previo con un inhibidor de ErbB1 y/o ErbB2 diferente a trastuzumab.
    3. Síndrome de malaabsorción, enfermedad que afecta de forma significativa a la función gastrointestinal, o resección del estómago o del intestino delgado. También se excluirá a las pacientes con colitis ulcerosa.
    4. Antecedentes de otras enfermedades tumorales. No obstante, serán elegibles aquellas pacientes que hayan estado sin enfermedad durante 5 años, o las pacientes con antecedentes de cáncer de piel no melanoma completamente resecado o carcinoma in situ tratado con éxito.
    5. Enfermedad concomitante que haría que la paciente no fuera apropiada para participar en el estudio, o cualquier trastorno médico grave que interferiría con la seguridad de la paciente.
    6. Toxicidad grave no resuelta o inestable debida a la administración previa de otro fármaco en investigación y/o tratamiento anticancerígeno previo.
    7. Infección activa o no controlada.
    8. Demencia, estado mental alterado, o cualquier enfermedad psiquiátrica que prohibiría la comprensión u obtención del consentimiento informado.
    9. Antecedentes conocidos de angina no controlada o sintomática, arritmias o insuficiencia cardiaca congestiva.
    10. Antecedentes conocidos o evidencias clínicas de carcinomatosis leptomeníngea.
    11. Tratamiento anticancerígeno concomitante (quimioterapia, radioterapia, inmunoterapia, terapia biológica, terapia hormonal).
    12. Tratamiento concomitante con un producto en investigación o participación en otro ensayo clínico.
    13. Utilización de un fármaco en investigación en un periodo de 3 semanas o 5 semividas, lo que sea superior, antes de la primera dosis del producto en investigación.
    14. Reacción de hipersensibilidad retardada o inmediata o idiosincrasia conocida a fármacos químicamente relacionados con trastuzumab o lapatinib o a sus excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia sin progresión
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Cruzado solamente de la monoterapia con lapatinib al de combinación de lapatinib con trastuzumab
    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.8.5The 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 Information not present in EudraCT
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    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 2005-12-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 270
    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)
    Cuidados estándar
    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 Decision2006-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-28
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