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    The EU Clinical Trials Register currently displays   35896   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-017848-14
    Sponsor's Protocol Code Number:ML25189
    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:2010-01-26
    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 number2009-017848-14
    A.3Full title of the trial
    Estudio fase II de capecitabina- oxaliplatino-trastuzumab (XELOX-trastuzumab) como tratamiento perioperatorio de pacientes con adenocarcinoma gástrico o de la unión gastroesofágica, resecable (estadios II-IV).
    A.3.2Name or abbreviated title of the trial where available
    NEOHX
    A.4.1Sponsor's protocol code numberML25189
    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 SponsorRoche Farma, S.A.
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo Monoclonal 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 XELODA 500 mg comprimidos recubiertos con película
    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 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 INNCAPECITABINA
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Pacientes diagnosticados de adenocarcinoma gástrico o de la unión gastroesofágica, resecable (estadios II-IV).
    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
    Supervivencia libre de enfermedad a los 18 meses en este grupo de pacientes.
    E.2.2Secondary objectives of the trial
    · Calcular el porcentaje de respuestas patológicas
    completas (RCp)
    · Calcular el porcentaje de resecciones completas (R0)
    · Calcular el porcentaje de respuestas objetivas (siguiendo los nuevos criterios RECIST)
    · Estimar la supervivencia global (SG)
    · Estimar la SLE en pacientes R0
    · Describir el perfil de seguridad de la combinación
    XELOX-trastuzumab y, específicamente, de trastuzumab en monoterapia (tratamiento de mantenimiento)
    · Describir la morbimortalidad quirúrgica
    · Realizar un estudio de biomarcadores (en la biopsia inicial y en la pieza quirúrgica, tras el tratamiento preoperatorio del estudio) y su relación con la respuesta al tratamiento. Se estudiarán: PTEN, K-Ras, C-myc, IGF-IR, HER3, p95HER2 y PI3K, VEGF y EGER.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Antes del comienzo de los procedimientos específicos del protocolo, deberá obtenerse y documentarse el consentimiento informado por escrito.
    2. Pacientes diagnosticados histológicamente de
    adenocarcinoma gástrico o de la unión gastroesofágica (tipos I, II, y III de Siewert) (ver anexo 9) que, tras el estudio clínico inicial (ecoendoscopia y TAC; la laparoscopia es
    opcional) sea considerado localmente avanzado (T3, T4 o N0-3, M0). La resecabilidad será evaluada antes del tratamiento y sólo serán incluidos los pacientes potencialmente resecables. Se considerará criterio de irresecabilidad la afectación de cualesquiera de los siguientes órganos:
    a. Cabeza del páncreas
    b. Mesocolon transverso
    c. Arteria mesentérica superior, aorta
    d. Hilio hepático
    e. Retroperitoneo, diafragma
    3. Tumor HER2-positivo: HER2 +++ por inmunoquímica (IHC 3+) o HER2 ++ por inmunoquímica más FISH + (IHC2+/FISH+).
    4. Enfermedad medible (según los nuevos criterios RECIST) o evaluable
    5. Edad igual o superior a 18 años.
    6. Estado funcional ECOG < 2.
    7. Pacientes con una esperanza de vida de al menos 12 semanas.
    8. Función hematológica adecuada:
    a. Recuento absoluto de neutrófilos (RAN) > 1.5 x 109/L
    b. Recuento de plaquetas > 100 x 109/L
    9. Función hepatica adecuada:
    a. Bilirrubina total < 2 mg/dL
    b. GOT (AST)/ GPT (ALT) < 5 veces el límite superior de la normalidad (LSN)
    c. Fosfatasa alcalina < 3 veces el LSN
    10. Función renal adecuada: aclaramiento de creatinina > 30 ml/min, calculado según la fórmula de Cockroff – Gault (anexo 7)
    11. Función cardiaca adecuada: FEVI > 50%.
    12. Las mujeres potencialmente fértiles deberán tener un test de embarazo negativo en suero u orina, realizado en los 7 días previos a la primera administración de los fármacos del estudio (las mujeres postmenopáusicas deben haber
    permanecido amenorreicas durante al menos 12 meses).
    Asimismo deberán utilizar un método anticonceptivo adecuado (contraceptivos orales, dispositivo intrauterino, métodos anticonceptivos de barrera junto con gel espermicida, o ser quirúrgicamente estériles) hasta al menos 12 meses después de la finalización del tratamiento o de la última dosis, lo que ocurra primero.
    13. Los pacientes deben ser tratados y seguidos en el centro participante.
    14. Los pacientes deben estar accesibles para el tratamiento y el seguimiento. Los pacientes deben expresar su deseo de cumplir lo estipulado en el protocolo durante toda la duración del estudio.
    E.4Principal exclusion criteria
    1. Quimioterapia o radioterapia previa para tumores gástricos o algún tipo de resección previa del tumor. La realización de una laparoscopia diagnóstica anterior no será considerado un criterio de exclusión.
    2. Presencia de enfermedad cardiaca concomitante en los últimos 12 meses previos al reclutamiento
    a. Historia de arritmia auriculoventricular sintomática no controlada con medicación o que puede potencialmente interferir con el tratamiento de estudio, y/o
    b. Insuficiencia cardiaca congestiva de grado ³ II de la New York Heart Association (NYHA) y/o
    c. Infarto de miocardio, y/o
    d. Cardiopatía isquémica sintomática.
    3. Hipersensibilidad conocida a cualquiera de los fármacos del estudio o a sus excipientes.
    4. Antecedentes de reacciones adversas graves inesperadas al tratamiento con fluoropirimidinas y/o déficit conocido de dihidropirimidina deshidrogenasa (DPD).
    5. Presencia de un proceso infeccioso activo clínicamente relevante
    6. Alguna patología médica severa (ej., SIDA, etc.) que pueda interferir con la administración del tratamiento de estudio al paciente.
    7. Enfermedades concomitantes graves o no adecuadamente controladas.
    8. Historia de otra enfermedad neoplásica durante los últimos cinco años, con la excepción de carcinomas curados de células basales de la piel y de cervix in situ.
    9. Pacientes que debido a su lugar de residencia, situación social o patología psiquiátrica pueda ser complicada la administración del tratamiento de estudio o la realización de las visitas de seguimiento.
    10. Cualquier otra condición o terapia que, a juicio del investigador o por indicación del prospecto de alguno de los fármacos de estudio, pueda implicar algún riesgo para el paciente o interferir con los objetivos del estudio.
    11. Tratamiento con cualquier otro fármaco en investigación no comercializado, en los 30 días previos al inicio del tratamiento de estudio.
    E.5 End points
    E.5.1Primary end point(s)
    · Supervivencia libre de enfermedad (SLE) a los 18 meses.
    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 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 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 concerned14
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    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 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 state45
    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 Decision2010-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
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