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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2008-000225-19
    Sponsor's Protocol Code Number:GETNE0801
    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:2008-04-08
    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 number2008-000225-19
    A.3Full title of the trial
    ENSAYO CLÍNICO DE FASE II, MULTICÉNTRICO, ABIERTO, NO CONTROLADO PARA EVALUAR LA EFICACIA DE LA COMBINACIÓN DE SORAFENIB Y BEVACIZUMAB EN EL TRATAMIENTO DE PACIENTES CON TUMOR NEUROENDOCRINO AVANZADO Y/O METASTÁSICO
    A.4.1Sponsor's protocol code numberGETNE0801
    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 GETNE
    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 Nexavar®
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNSorafenib
    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: 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®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 con tumor neuroendocrino avanzado y/o metastásico confirmado histológicamente.
    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
    • Determinar la tasa de supervivencia libre de progresión (PFR)*, en pacientes con tumor neuroendocrino avanzado y/o metastásico, tras 6 meses de tratamiento con la combinación de sorafenib y bevacizumab.
    E.2.2Secondary objectives of the trial
    • Determinar la supervivencia libre de progresión (PFS)* con la combinación en estudio.
    • Determinar el tiempo hasta la progresión (TTP)* con la combinación en estudio.
    • Determinar la tasa de respuesta objetiva (ORR)* tras 6 meses de tratamiento con la combinación en estudio.
    • Determinar la supervivencia global (OS)* con la combinación en estudio.
    • Determinar los niveles circulantes de marcadores tumorales (Cromogranina A en suero o plasma y 5-HIAA en orina) durante el ensayo.
    • Evaluar la seguridad y tolerabilidad de la combinación en estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes de edad igual o superior a 18 años.
    2. Pacientes con tumor neuroendocrino (NET) confirmado histológicamente: tumor carcinoide (inluyendo localización bronquial), carcinoma de células de los islotes u otro tumor moderadamente diferenciado o bien diferenciado.
    3. Pacientes con enfermedad metastásica que presenten enfermedad medible según criterios RECIST.
    4. Pacientes con ECOG de 0 a 2.
    5. Pacientes con una esperanza de vida mínima de 24 semanas.
    6. Pacientes con adecuada función hematológica, definida como: recuento absoluto de neutrófilos ≥ 1,5x109/L; plaquetas totales ≥ 100x109/L.
    7. Pacientes con función hepática y renal adecuada definida como: bilirrubina total ≤ 2 x LSN; GOT y GPT ≤ 3 x LSN (o < 5,0 x LSN en pacientes con metástasis hepáticas); creatinina ≤ 1,5 x LSN.
    8. Pacientes con INR normal y PTT normal (según rangos específicos de cada centro).
    9. Mujeres con prueba de embarazo negativa en los 7 días previos al comienzo de la administración del tratamiento del ensayo.
    10. Pacientes que otorguen su consentimiento informado por escrito previamente a su inclusión en el ensayo.
    11. Pacientes capaces de cumplir con los requisitos del estudio y sin impedimentos para seguir las instrucciones a lo largo del estudio.
    E.4Principal exclusion criteria
    1. Pacientes tumor neuroendocrino pobremente diferenciado, indiferenciado o tumor de células pequeñas.
    2. Pacientes con carcinoma tiroideo de cualquier histología, timoma o feocromocitoma/paraganglioma.
    3. Pacientes con historia de enfermedad maligna durante los 5 años previos a la inclusión excepto carcinoma basocelular de piel tratado previamente y carcinoma in situ de cervix. Se valorarán los casos específicos de tumores controlados y sin evidencia de enfermedad reciente (últimos 3 meses) de más de 5 años de evolución.
    4. Pacientes con metástasis óseas como única localización de la enfermedad.
    5. Pacientes con signos o síntomas de lesiones cerebrales.
    6. Pacientes que hayan recibido más de 1 tratamiento quimioterápico previamente a su inclusión en el estudio. La quimioembolización y la inmunoterapia no se considera un tratamiento activo de quimioterapia.
    7. Pacientes que estén recibiendo o hayan recibido en los últimos 30 días quimioterapia, inmunoterapia u otro tratamiento en investigación.
    8. Pacientes que estén recibiendo radioterapia o la hayan recibido en las últimas 2 semanas.
    9. Pacientes que hayan recibido quimioembolización o hayan sido intervenidos de cirugía mayor en las últimas 4 semanas.
    10. Pacientes con hipertensión arterial no controlada en los últimos 3 meses a pesar de recibir un tratamiento médico adecuado.
    11. Pacientes con historia previa o síntomas de insuficiencia cardíaca congestiva, enfermedad coronaria activa o cardiopatía isquémica (IAM en los 6 meses previos) o arritmia cardíaca grave.
    12. Pacientes con diabetes mellitus no controlada, definida por una glucosa en ayunas > 2,0 x LSN.
    13. Pacientes con infección activa u otra enfermedad o condición médica grave, no controladas o cuyo control pueda verse afectado con el tratamiento del presente ensayo.
    14. Pacientes con alguna enfermedad gastrointestinal que incapacite la toma de medicación por vía oral (ej. gastrectomía total o disfagia severa grado 3-4 mal controlada en los últimos 2 meses) o con alteraciones de la absorción intestinal.
    15. Pacientes con diátesis hemorrágica o con sangrado activo en cualquier localización.
    16. Pacientes que presenten alguna contraindicación o con sospecha de alergia o alergia conocida a los fármacos del ensayo.
    17. Pacientes en edad fértil que no utilicen métodos anticonceptivos eficaces, y que no se comprometan a seguir utilizándolos como mínimo durante 4 semanas en mujeres y 3 meses en varones tras la finalización del tratamiento, o mujeres gestantes o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    • Porcentaje de pacientes, con tumor neuroendocrino avanzado y/o metastásico, que permanecen vivos y libres de progresión, tras 6 meses de tratamiento con la combinación de sorafenib y bevacizumab.
    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 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 concerned8
    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
    Según protocolo
    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 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 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 state44
    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 Decision2008-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-08
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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