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    Summary
    EudraCT Number:2010-020101-32
    Sponsor's Protocol Code Number:OAM4861g
    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:2010-07-06
    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 number2010-020101-32
    A.3Full title of the trial
    A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF METMAB IN COMBINATION WITH
    PACLITAXEL AND BEVACIZUMAB IN PATIENTS WITH METASTATIC, TRIPLE-NEGATIVE BREAST CANCER
    Estudio aleatorizado, en fase II, multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de metmab en combinación con paclitaxel y bevacizumab en pacientes con cáncer de mama metastásico triple negativo
    A.4.1Sponsor's protocol code numberOAM4861g
    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 SponsorGENENTECH, Inc.
    B.1.3.4CountryUnited States
    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 nameMetMAb
    D.3.2Product code PRO143966
    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 INNn.a.
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codePRO143966
    D.3.9.3Other descriptive nameOA5D5; rhuMAbOA5D5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal monovalente recombinante humanizado
    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 Yes
    D.2.1.1.1Trade name AVASTIN 25 mg/ml 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 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 INNBEVACIZUMAB
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive nameBEVACIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal humanizado recombinante
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic, triple-negative breast cancer
    Cáncer de mama metastásico triple negativo
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Calcular el efecto clínico beneficioso de MetMAb + bevacizumab + paclitaxel en comparación con placebo + bevacizumab + paclitaxel,
    determinado mediante la SSP valorada por el investigador, en pacientes con cáncer de mama metastásico o localmente recurrente triple negativo,
    que no hayan recibido tratamiento sistémico previo o que hayan mostrado progresión después de un tratamiento de primera línea
    E.2.2Secondary objectives of the trial
    * Evaluar el beneficio para la supervivencia global de MetMAb + bevacizumab + paclitaxel en comparación con placebo + bevacizumab + paclitaxel en pacientes con cáncer de mama metastásico o localmente
    recurrente triple negativo, que no hayan recibido tratamiento sistémico previo o hayan progresado después de un tratamiento de primera línea
    * Describir la seguridad y la tolerabilidad de MetMAb + bevacizumab + paclitaxel
    * Evaluar la concentración mínima (Cmín) y la concentración máxima (Cmáx) tanto de MetMAb como de bevacizumab
    * Evaluar las concentraciones séricas y la incidencia de anticuerpos antiterapéuticos (AAT) contra MetMAb y contra bevacizumab
    * Evaluar el efecto de MetMAb en los siguientes parámetros del ECG:intervalo QT corregido (QTc), frecuencia cardíaca, intervalo QT no corregido, intervalo PR, duración del QRS y morfología de las ondas T y las ondas U
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Título del protocolo:SUBESTUDIO DE DEPÓSITO DE ADN EN ASOCIACIÓN CON EL ESTUDIO METMAB
    OAM4861g. Fecha y versión: 13 May 2010, OAM4861g (subestudios de ADN).Objetivos:El objetivo principal de este estudio es realizar análisis exploratorios para generar hipótesis que identifiquen los genes asociados a la respuesta al tratamiento, la toxicidad o el riesgo de enfermedad. Si se identifican dichas hipótesis genéticas, pueden examinarse en futuros estudios clínicos dentro de este campo terapéutico.
    E.3Principal inclusion criteria
    * Mujeres >= 18 años de edad
    * Estado funcional de 0 ó 1 según el Eastern Cooperative Oncology Group
    (ECOG)
    *Adenocarcinoma de mama triple negativo (ER-negativo, PR-negativo y HER-2 negativo) confirmado histológicamente, con enfermedad metastásica o localmente recurrente mensurable o no mensurable
    E.4Principal exclusion criteria
    * Tratamiento previo con dos o más pautas para el cáncer de mama metastásico.* Cualquier tratamiento antineoplásico sistémico en las 3 semanas previas al día 1 del ciclo 1.* Intervención de cirugía mayor (excepto cirugía del SNC), biopsia abierta o lesión traumática importante en los 30 días anteriores al día 1 del ciclo 1, o previsión de la necesidad de una intervención de cirugía mayor durante el curso del estudio.*Tratamiento previo con un taxano para el cáncer de mama metastásico.* Tratamiento previo con bevacizumab, sorafenib, sunitinib u otros supuestos tratamientos dirigidos a la vía del VEGF tras el diagnóstico de cáncer de
    mama.*Tratamiento previo con hormonas y/o trastuzumab. *Angina inestable.*Antecedentes de crisis hipertensivas o encefalopatía hipertensiva. * Insuficiencia cardíaca congestiva de grado &#8805; II de la New York Heart Association. *Antecedentes de infarto de miocardio en los 6 meses previos al día 1 del ciclo 1. *Embarazo (prueba de embarazo en suero positiva) o lactancia
    ciclo 1
    E.5 End points
    E.5.1Primary end point(s)
    Se utilizarán los métodos de Kaplan-Meier para calcular la mediana de la SSP de cada grupo
    de tratamiento. La SSP se define como el tiempo transcurrido desde la aleatorización hasta la
    progresión o la recidiva de la enfermedad (evaluada por el radiólogo y/o el investigador del
    centro, utilizando los RECIST, versión 1.1) o hasta la muerte durante el estudio por cualquier
    causa (definida como la muerte en el plazo de 30 días después de la última dosis del
    tratamiento del estudio), lo que suceda antes En las pacientes que no hayan fallecido ni presentado progresión de la enfermedad al final del estudio, la SSP se fijará en la última fecha que se tenga constancia de la ausencia de 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    MetMab+BEV+Paclitaxel vs placebo+BEV+Paclitaxel
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Se realizarán análisis de la eficacia cuando se hayan producido aproximadamente 84 acontecimientos de SSP.Los pacientes que sigan beneficiándose
    del tratamiento podrán seguir en este estudio durante un máximo de 24 meses.
    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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 120
    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)
    Los pacientes que finalicen el ensayo volverán a la terapia estándar de acuerdo con su régimen de asistencia sanitaria.
    Para los pacientes que discontinúan el tratamiento por cualquier razón y pacientes con un acontecimiento adverso o SAE sin resolver, por favor refiérase a la sección 3.4 del protocolo del estudio
    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 Decision2010-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-08
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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