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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43854   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:2009-011037-27
    Sponsor's Protocol Code Number:ML22197/2009-01
    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:2009-04-21
    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 number2009-011037-27
    A.3Full title of the trial
    Estudio fase II, multicéntrico, para evaluar los marcadores predictores de respuesta en cáncer
    de mama localmente avanzado, tratado con bevacizumab en combinación con quimioterapia
    neoadyuvante.
    A.4.1Sponsor's protocol code numberML22197/2009-01
    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 SponsorInstituto Científico Tecnológico de Navarra (ICTN)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 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.3.9.3Other 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 producido por tecnología del ADN recombinante en células ováricas de hámster chino.
    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.3.9.3Other descriptive nameBEVACIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 producido por tecnología del ADN recombinante en células ováricas de hámster chino.
    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 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 nameDOCETAXEL
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 114977-28-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 nameadriamicina
    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 INNadriamicina
    D.3.9.1CAS number 23214-92-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeantibiotico citotoxico
    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 Mama localmente avanzado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    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
    Evaluar la asociación de variables moleculares y de imagen con la respuesta completa
    patológica (RCp) en las pacientes con cáncer de mama localmente avanzado, tratados
    con terapia neoadyuvante que contenga bevacizumab.
    E.2.2Secondary objectives of the trial
    •Evaluar la seguridad del tratamiento
    •Determinar la proporción de respuestas patológicas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sexo mujer
    2. Antes del comienzo de los procedimientos específicos del protocolo, deberá obtenerse y documentarse el consentimiento informado por escrito.
    3. Edad >18 años y &#8804;70 años.
    4. Expectativa de vida de al menos 12 meses
    5. Cáncer de mama confirmado histologicamente: T2-3,N0M0 ó cualquier T, N1-2M0.
    6. No tratamiento previo para enfermedad localmente avanzada
    7. Her 2 + o Her 2 -
    8. Enfermedad medible radiológicamente para evaluación de la respuesta mediante PET y/o MRI
    9. Capacidad funcional ECOG 0-1.
    10. Función orgánica adecuada según los siguientes criterios:
    a. Reserva medular: recuento absoluto de neutrófilos (RAN) > 1.5 x 109L, plaquetas > 100 x 109L y hemoglobina > 10 g/dL (se permite la transfusión sanguínea).
    b. Función hepática:
    i. Bilirrubina <1,5 x límite superior de la normalidad (LSN).
    ii. AST y ALT < 2,5 x LSN.
    iii. Fosfatasa Alcalina < 2,5 x LSN.
    c. Función renal:
    i. Creatinina < 1,5 x LSN.
    ii. Aclaramiento de creatinina calculado > 50 mL/min. (según la fórmula de Cockcroft-Gault, (Ver Apéndice 7).
    iii. Análisis de orina con tira reactiva para proteinuria <2+. En los pacientes con proteinuria &#8805; 2+ en el análisis de orina por tira reactiva en el periodo basal se recogerá la orina de 24 horas y deberán demostrar &#8804; 1 g de proteínas en 24 horas
    d. Tiempo de protombina (TP) o INR &#8804; 1.5 y tiempo de tromboplastina parcial (TTP) o tiempo de tromboplastina parcial activada (TTPa) dentro de los límites normales
    e. Función cardiaca normal, confirmada con una valoración de la fracción de eyección del ventrículo izquierdo (FEVI) y un electrocardiograma. El resultado de la FEVI deberá ser > 50%.
    11. A las mujeres potencialmente fértiles se les deberá realizar una prueba de embarazo sérica, que debe ser negativa en el plazo de 7 días antes de la aleatorización. Asimismo, deberán usar métodos contraceptivos adecuados ( por ej, abstinencia, dispositivo intrauterino, método de doble barrera), comenzando a la firma del consentimiento informado y durante &#8805;30 días después de la última administración de los fármacos del estudio
    12. Las pacientes deben tener la capacidad, en opinión del investigador, de cumplir todos los procedimientos y exploraciones de seguimiento del estudio.
    E.4Principal exclusion criteria
    1. Enfermedad metastásica
    2. No aceptable estado general para que la pacientes sea candidata a recibir quimioterapia basada en taxanos y antraciclinas)
    3. Tratamiento previo para el cáncer de mama (quimioterapia, radioterapia u hormonoterapia)
    4. Mujeres embarazadas o en período de lactancia.
    5. Cirugía mayor (incluyendo biopsia quirúrgica), lesiones traumáticas significativas, dentro de los 28 días previos a la inclusión ó conocimiento previo del requerimiento de cirugía mayor durante el tratamiento en estudio.
    6. Cirugía menor, incluyendo la inserción de catéter endovenoso, dentro de las 24 horas previas a la primera infusión de bevacizumab.
    7. Tratamiento concomitante ó reciente (dentro de los 10 días de la primera dosis de bevacizumab) con aspirina >325 mg/día ó clopidrogel >75 mg/día.
    8. Tratamiento concomitante ó reciente (dentro de los 10 días de la primera dosis de bevacizumab) con anticoagulantes orales a dosis plenas ó anticoagulantes parenterales ó terapia trombolítica con fines terapéuticos. El uso profiláctico de anticoagulantes a dosis bajas está permitido.
    9. Historia o evidencia de diátesis hemorrágica o coagulopatía hereditaria con riesgo de sangrado
    10. Hipertensión arterial no controlada (sistólica > 150 mm Hg y/o diastólica > 100 mm Hg) a pesar de tratamiento médico adecuado.
    11. Enfermedad cardiovascular clínicamente significativa: por ejemplo, ACV (en los 6 meses previos a la inclusión), IAM en los últimos 6 meses, angina inestable, insuficiencia cardiaca congestiva de grado &#8805; II de la New York Heart Association (NYHA) o arritmias cardiacas severas no controladas con medicación o que puedan potencialmente interferir con el tratamiento de estudio
    12. Heridas no cicatrizadas, ulcus péptico activo ó fracturas óseas
    13. Historia de fístula abdominal, perforación gastrointestinal, o absceso intra-abdominal en los 6 meses previos a la inclusión.
    14. Evidencia de cualquier otra enfermedad, alteración neurológica o metabólica, hallazgo de la exploración física o de laboratorio que proporcione indicios razonables para sospechar una enfermedad o afección que contraindique el uso de alguno de los fármacos del estudio, o que coloque al paciente en alto riesgo de experimentar complicaciones relacionadas con el tratamiento.
    15. Alteraciones psiquiátricas que a juicio del investigador puedan interferir con el cumplimiento del tratamiento en estudio.
    16. Tratamiento en la actualidad o recientemente con otro fármaco en investigación o participación en otro estudio de investigación en los 28 días previos a la inclusión en el estudio.
    17. Tratamiento crónico diario con corticoides (excepto que haya sido iniciado >6 meses y con una dosis &#8804;10mg/día de metilprednisolona).
    18. Hipersensibilidad conocida a bevacizumab o cualquiera de sus componentes ó cualquiera de los fármacos del estudio o sus componentes
    19. Pacientes diagnosticadas con otras neoplasias dentro de los últimos cinco años, excluyendo cáncer de piel no melanoma y carcinoma resecado de cérvix.
    E.5 End points
    E.5.1Primary end point(s)
    Eficacia
    • Evaluación de la respuesta tumoral por análisis de imagen (DCE-MRI; PET-FLT y PET-Misonidazol).
    • Análisis de SNPs para buscar factores predictivos de respuesta al tratamiento.
    • Expresión genómica completa y expresión de micro-RNA como marcadores predictivos de respuesta al tratamiento.
    • Perfil de expresión proteómica en muestras de suero como marcador predictivo de respuesta al tratamiento.

    Seguridad
    • Frecuencia de efectos adversos según criterios NCI-CTC versión 3.0.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    asociación de variables moleculares y de imagen con la respuesta patológica
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    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 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 concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned 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 state75
    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 Decision2009-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-31
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