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    Summary
    EudraCT Number:2007-006637-14
    Sponsor's Protocol Code Number:A6181170
    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:2008-07-24
    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 number2007-006637-14
    A.3Full title of the trial
    "Estudio en fase 3, abierto, aleatorizado, multinacional de malato de sunitinib frente a sorafenib en pacientes con carcinoma hepatocelular avanzado"

    A MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PHASE 3 STUDY OF SUNITINIB MALATE VERSUS SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA
    A.4.1Sponsor's protocol code numberA6181170
    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
    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 12,5 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER 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.3.1Product nameSUTENT
    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.3.9.2Current sponsor codeSU0011248
    D.3.9.3Other descriptive nameSUNITINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 NEXAVAR 200 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HEALTHCARE AG
    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 nameSORAFENIB
    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 INNSORAFENIB TOSILATO
    D.3.9.3Other descriptive nameSORAFENIB TOSILATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 25 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER 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.3.1Product nameSUTENT
    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.3.9.2Current sponsor codeSU0011248
    D.3.9.3Other descriptive nameSUNITINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    "Carcinoma Hepatocelular avanzado"

    "Advanced Hepatocellular Carcinoma"
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049010
    E.1.2Term Carcinoma hepatocellular
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que la supervivencia global es superior o equivalente con sunitinib en comparación con sorafenib en pacientes con carcinoma hepatocelular avanzado.
    E.2.2Secondary objectives of the trial
    ? Comparar la supervivencia sin progresión y el tiempo hasta la progresión tumoral entre ambos grupos de tratamiento
    ? Evaluar la seguridad y la tolerabilidad del sunitinib en esta población de pacientes.
    ? Comparar el estado de salud entre ambos grupos de tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Suplemento de Perfil Molecular, Version de fecha 20 de Marzo de 2008.

    Objetivo Principal:

    El objetivo principal de esta investigación adicional es obtener, almacenar y utilizar muestras para investigar las posibles asociaciones entre la variación genómica y metabolómica:
    ? En relación con la respuesta a los fármacos del estudio y
    ? En relación con las características de la enfermedad o trastorno que se estudia en el ensayo clínico asociado y de otros procesos asociados.

    Además, las muestras podrán utilizarse como controles en investigaciones genómicas y metabolómicas de las causas, la historia natural y otros aspectos de enfermedades y trastornos importantes para los que Pfizer está investigando tratamientos farmacológicos nuevos o mejorados.
    E.3Principal inclusion criteria
    Los pacientes deberán cumplir todos estos criterios de inclusión para poder participar en el estudio:
    1. Diagnóstico confirmado histológicamente de carcinoma hepatocelular localmente avanzado o metastásico (es aceptable el diagnóstico histológico obtenido de una muestra de biopsia tumoral previa).
    2. Enfermedad mensurable según los criterios RECIST. Al menos una lesión diana no debe haber recibido previamente ningún tratamiento local, como cirugía, radioterapia, embolización arterial hepática, TACE-quimioembolización transarterial, infusión arterial hepática, ablación por radiofrecuencia, inyección percutánea de etanol o crioablación, a menos que haya progresado posteriormente según los criterios RECIST.
    3. Resolución de todos los efectos tóxicos agudos de cualquier tratamiento local previo a grado ? 1 de los Criterios terminológicos comunes para acontecimientos adversos (CTCAE) versión 3.0 del National Cancer Institute (NCI).
    4. Clase A de Child Pugh (para la determinación de la clase de Child Pugh, utilice la tabla del Apéndice 5).
    5. Pacientes de 18 o más años de edad.
    6. Estado funcional (ECOG) de 0 ó 1.
    7. Datos de laboratorio basales dentro de los siguientes parámetros:
    ? Neutrófilos, ? 1.500/µl
    ? Plaquetas ? 75.000/µl
    ? Hemoglobina ? 9,0 g/dl
    ? Aspartato aminotransferasa sérica (AST; transaminasa glutamato oxalacetato sérica [SGOT]) y alanina aminotransferasa sérica (ALT; transaminasa glutamato piruvato sérica [SGPT]) ? 5 x LSN
    ? Creatinina sérica ? 1,5 x LSN
    ? INR < 1,7 o tiempo de protrombina (TP) < 4 segundos por encima del LSN
    ? Albúmina sérica > 3,5 g/dl (* ? 2,8 g/dl)
    ? Bilirrubina total < 2 mg/dl (* ? 3 mg/dl)
    * SÓLO UNO de estos 2 últimos criterios puede tener una puntuación de 2 según el sistema de puntuación de Child Pugh.
    8. Candidato para el tratamiento con sorafenib. El investigador debe asegurarse antes de la aleatorización de que se cumplen las precauciones de seguridad detalladas en el prospecto de sorafenib41 o documentación equivalente pero no indicadas en los criterios de inclusión del estudio (p. ej., sorafenib está contraindicado en pacientes con intensa hipersensibilidad conocida a sorafenib o cualquier otro componente de NEXAVAR®).
    9. Consentimiento informado firmado y fechado en el que se indica que el paciente (o su representante legal) ha sido informado de todos los aspectos pertinentes del estudio antes de su inclusión.
    10. Disposición y capacidad de cumplir las visitas programadas, los planes de tratamiento, las pruebas analíticas y otros procedimientos del estudio, entre ellos, la cumplimentación de los cuestionarios de resultados comunicados por los pacientes (RCP).
    E.4Principal exclusion criteria
    No se incluirá en el estudio a los pacientes que presenten alguno de los criterios siguientes:
    1. Tratamiento sistémico previo para el CHC, incluido el tratamiento previo con sunitinib o sorafenib u otro fármaco experimental.
    2. Cualquier tratamiento local previo (como cirugía, radioterapia, embolización arterial hepática, TACE-quimioembolización transarterial, infusión arterial hepática, ablación por radiofrecuencia, inyección percutánea de etanol o crioablación) en las 4 semanas previas a la incorporación al estudio.
    3. Antecedentes de trasplante hepático.
    4. Presencia de ascitis clínicamente relevante (p. ej., que precisa paracentesis terapéutica o que puede clasificarse como una puntuación de Child Pugh ? 2).
    5. Hemorragia de grado ? 3 de los CTCAE del NCI en las 4 semanas previas al inicio del tratamiento del estudio o hemorragia varicosa documentada de cualquier grado en los 12 meses previos a la incorporación al estudio (como se documenta por la endoscopia).
    6. Presencia de varices esofágicas con riesgo de hemorragia y/o herida/úlcera grave o que no cicatriza (documentada por endoscopia).
    7. Antecedentes de fístula abdominal, perforación gastrointestinal o absceso intrabdominal en los 28 días previos a la incorporación al estudio.
    8. Cualquiera de los trastornos siguientes en los 12 meses previos a la administración del fármaco del estudio: angina grave o inestable, infarto de miocardio, injerto de derivación arterial coronaria, insuficiencia cardíaca congestiva sintomática, accidente cerebrovascular incluido el accidente isquémico transitorio o embolia pulmonar.
    9. Diagnóstico de una segunda neoplasia maligna en los últimos 3 años, salvo carcinoma basocelular, carcinoma espinocelular o carcinoma in situ del cuello uterino que ha sido tratado correctamente sin signos de recidiva durante 12 meses.
    10. Antecedentes de metástasis cerebrales, compresión de la médula espinal, meningitis carcinomatosa o nuevos signos de afectación cerebral o leptomeníngea.
    11. Presencia de arritmias cardíacas de grado ? 2 según los CTCAE del NCI, fibrilación auricular de cualquier grado o prolongación del intervalo QTc > 450 ms en varones o > 470 ms en mujeres.
    12. Hipertensión que no se puede controlar con fármacos (presión arterial >150/100 mm Hg a pesar de un tratamiento médico óptimo).
    13. Tratamiento con un inhibidor potente de la CYP3A4 en los 7 días anteriores a la incorporación al estudio o con un inductor potente de la CYP3A4 en los 12 días previos a la incorporación al estudio.
    14. Tratamiento simultáneo con una formulación botánica que tenga una indicación aprobada para el tratamiento del cáncer, como ?Xiao Chai Hu Tang?, ?Kanglaite?, etc.
    15. Tratamiento continuo con niveles terapéuticos de derivados de la cumarina o fármacos orales anti vitamina K.
    16. Incapacidad de tragar los medicamentos orales o presencia de enfermedad intestinal inflamatoria activa, obstrucción intestinal total o parcial o diarrea crónica.
    17. Enfermedad relacionada con el virus de la inmunodeficiencia humana (VIH) o con el síndrome de inmunodeficiencia adquirida (SIDA).
    18. Embarazo o lactancia. Todas las mujeres en edad fértil deberán obtener un resultado negativo en una prueba de embarazo (en suero u orina) en los 7 días anteriores al reclutamiento.
    19. Mujeres en edad fértil que no deseen o no puedan usar una anticoncepción eficaz, tal como se define en las Pautas sobre los hábitos de vida, sección 4.4, para evitar el embarazo durante el estudio.
    20. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía de laboratorio que pueda aumentar el riesgo asociado a la participación en el ensayo o a la administración del fármaco del estudio o interferir en la interpretación de los resultados del estudio y, en opinión del investigador, impedir la participación en este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia General (SG)
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerabilidad
    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) 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 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 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.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Ver seccion 13 del protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 580
    F.4.2.2In the whole clinical trial 1200
    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)
    Ver 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 Decision2008-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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