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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2007-003206-96
    Sponsor's Protocol Code Number:ML21154
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-11-23
    Trial 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 number2007-003206-96
    A.3Full title of the trial
    “Estudio Fase II de Capecitabina y Erlotinib como tratamiento de primera línea en pacientes con cáncer de páncreas metastático (estadio IV)”
    A.3.2Name or abbreviated title of the trial where available
    XELTA
    A.4.1Sponsor's protocol code numberML21154
    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 SponsorGrupo Gallego de Investigaciones Oncológicas (GGIO)
    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 Xeloda
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 to 500
    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 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 Tarceva
    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 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 INNErlotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 to 150
    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
    Cáncer pancreático metastásico.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic 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
    Establecer la eficacia de la combinación de capecitabina y erlotinib en primera línea paliativa de cáncer de páncreas metastásico mediante la determinación de la tasa de respuestas objetivas, según criterios RECIST.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este ensayo clínico son los siguientes:

    - Determinar supervivencia global
    - Determinar la tasa de supervivencia a los 6 meses
    - Determinar supervivencia libre de progresión (SLP) y tiempo al fallo del tratamiento (TFT)
    - Determinar el índice de respuesta de beneficio clínico (RBC), según criterios de Burris.
    - Determinar la duración de la supervivencia libre de progresión (SLP).
    - Determinar la seguridad y tolerancia de la combinación de capecitabina y erlotinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.- Consentimiento informado por escrito otorgado por el paciente.
    2.- Edad ≥ 18 años.
    3.- Capacidad para cumplir los requisitos del protocolo.
    4.- Estado funcional de Karnofsky ≥ 60%.
    5.- Esperanza de vida ≥ 12 semanas.
    6.- Cáncer pancreático confirmado histológica o citológicamente (excluyendo tumores pancreáticos endocrinos), con enfermedad metastásica (estadio IV), según la 6ª edición de la clasificación TNM.
    7.- Presencia de enfermedad medible, según criterios RECIST.
    8.- Función de médula ósea adecuada: recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 109/L; recuento de plaquetas ≥ 100 x 109/L; hemoglobina ≥ 9 g/dL.
    9.- Función hepática adecuada:
    9.1.- Bilirrubina sérica (total): ≤ 1,5 x LSN.
    9.2.- AST, ALT ≤ 2,5 x LSN en pacientes sin metástasis hepáticas; ≤ 5 x LSN en pacientes con metástasis hepáticas.
    10.- Función renal adecuada:
    10.1.- Aclaramiento de creatinina ≥ 60 mL/min.
    11.- Varones y mujeres potencialmente fértiles (incluyendo las mujeres que hayan tenido la última menstruación hace menos de 2 años) deberán utilizar métodos anticonceptivos eficaces (anticonceptivos orales, dispositivo intrauterino, métodos anticonceptivos de barrera, conjuntamente con espermicida, o esterilización quirúrgica).
    E.4Principal exclusion criteria
    1.- Cáncer pancreático local (estadio IA-IIB) y localmente avanzado (estadio III), según la 6ª edición de la clasificación TNM. Los pacientes con enfermedad metastásica que experimenten recidiva tras el diagnóstico inicial de enfermedad local o localmente avanzada podrán ser incluidos en este estudio.
    2.- Evidencia de compresión de médula espinal, meningitis carcinomatosa o de metástasis cerebrales. En caso de sospecha clínica de metástasis cerebrales, es obligatorio realizar TAC/RM cerebral en las 4 semanas previas a la inclusión.
    3.- Tratamiento sistémico previo para cáncer pancreático metastásico. Los pacientes sí podrán haber recibido quimioterapia adyuvante, siempre que la hayan recibido ≥ 4 semanas antes de la inclusión en el estudio. De haber recibido quimioterapia adyuvante previa, el paciente se debe haber recuperado de todas las toxicidades producidas por el tratamiento antes de la inclusión y se deben confirmar los indicios de progresión de la enfermedad (metastásica) tras la quimioterapia adyuvante.
    4.- Pacientes que hayan desarrollado otros tumores primarios en los 5 años previos a la inclusión, excepto carcinoma in situ de cérvix o cáncer de piel basocelular tratados adecuadamente.
    5.- Hipertensión no controlada o enfermedad cardiovascular clínicamente significativa (es decir, activa): accidente cerebrovascular/ictus (≤ 6 meses antes de la inclusión), infarto de miocardio (≤ 6 meses antes de la inclusión), angina inestable, insuficiencia cardiaca congestiva de grado II o superior de la New York Heart Association (NYHA, anexo 4) o arritmia cardiaca grave que precisa medicación.
    6.- Cualquier anomalía oftalmológica significativa de la superficie ocular conocida (no se recomienda el sucio de lentes de contacto).
    7.- No historia conocida de deficiencia en dihidropirimidina deshidrogenasa (DPD).
    8.- Incapacidad para tomar la medicación oral, procedimientos quirúrgicos previos que afecten a la absorción o impliquen la necesidad de alimentación intravenosa o nutrición parenteral con lípidos.
    9.- Mujeres embarazadas o en período de lactancia. Se deberá obtener un resultado negativo en una prueba de embarazo en los 7 días previos al inicio del tratamiento del estudio.
    10.- Tratamiento en la actualidad o en los 30 días previos al inicio del tratamiento del estudio con otro fármaco en investigación o participación en otro estudio de investigación.
    11.- Tratamiento previo con capecitabina o inhibidores del EGFR.
    12.- Cualquier otra enfermedad, alteración metabólica, hallazgo de la exploración física o de laboratorio clínico, que proporcione indicios razonables para sospechar una enfermedad o afección para la que está contraindicado el uso de un fármaco experimental o paciente con riesgo alto de experimentar complicaciones relacionadas con el tratamiento.
    13.- Hipersensibilidad conocida a cualquiera de los fármacos del estudio o sus componentes, o al 5-fluorouracilo.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la tasa de respuestas objetivas, según criterios RECIST
    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 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) 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 No
    E.8.1.2Open No
    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 No
    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 concerned9
    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
    La terminación del ensayo clínico tendrá lugar en la fecha de la última visita realizada por el último paciente participante en este estudio.
    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 months6
    E.8.9.1In the Member State concerned days
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state32
    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 Decision2008-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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