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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2010-023422-20
    Sponsor's Protocol Code Number:GETNE1003
    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:2010-12-02
    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 number2010-023422-20
    A.3Full title of the trial
    Estudio en fase II de everolimus, un inhibidor mTOR (de formulación oral), junto con OcteotrideLAR®, en pacientes adultos con tumores neuroendocrinos gastrointestinales avanzados no funcionales y bien diferenciados (TNE GI).
    A.3.2Name or abbreviated title of the trial where available
    EVERLAR
    A.4.1Sponsor's protocol code numberGETNE1003
    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 Español de Tumores Neuroendocrinos (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 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.3.4Pharmaceutical 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 INNEverolimus
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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 nameOcteotride LAR
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOcteotride LAR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Tumores neuroendocrinos gastrointestinales
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10062476
    E.1.2Term Tumor neuroendocrino
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es evaluar la eficacia de 10 mg/día de everolimus en combinación con 30 mg de octeotride LAR® i.m. cada 28 días, en el tratamiento de TNE GI avanzado
    E.2.2Secondary objectives of the trial
    Evaluar el beneficio clínico de 10 mg/día de everolimus en combinación con 30 mg de octeotride LAR i.m. cada 28 días, en el tratamiento de TNE GI avanzado.
    Evaluar el efecto de 10 mg/día everolimus en combinación con 30 mg de octeotride LAR® i.m. cada 28 días sobre la tasa de respuestas objetivas (RC o RP) así como sobre la duración de la respuesta.
    Determinar la supervivencia global de los pacientes (SG).
    Determinar la seguridad de everolimus (10mg/día) + Octeotride LAR® en pacientes con TNE GI avanzados, bien diferenciados y no funcionales.
    Estudiar el estado de activación de la vía mTOR de transducción de la señal (en el tumor) como posible factor pronóstico de la respuesta al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes adultos de 18 años de edad.
    2. Diagnóstico de TNE GI avanzado no operable o metastásico, no funcional y bien diferenciado, confirmado mediante citología o histología. En caso de metástasis hepáticas, se admiten tumores neuroendocrinos de origen desconocido.
    3. Confirmación de diagnóstico de carcinoma neuroendocrino de grado histológico bajo a intermedio.
    4. Pacientes de los que, que habiendo sido tratados con cirugía, se dispone del bloque de tumor primario o metástasis incluido en parafina.
    5. Progresión de la enfermedad en los 12 meses anteriores a su inclusión en el estudio, documentada de forma radiológica. Si el paciente recibió tratamiento antitumoral durante los últimos doce meses, la progresión de la enfermedad debe estar documentada mediante radiología durante o después de la toma de dicha medicación.
    6. Esperanza de vida de > 3 meses.
    7. Estado funcional 0 2 basado en la escala de la OMS.
    8. La enfermedad debe ser medible según los criterios RECIST, mediante una valoración radiológica de TAC trifásico o RM de fase múltiple.
    9. Se admite tratamiento previo con análogos de somatostatina.
    10. Función adecuada de la médula ósea, demostrada por RAN > 1.5 x 109/L, plaquetas > 100 x109/L, hemoglobina > 9 g/dL.
    11. Función hepática adecuada demostrada por: bilirrubina sérica < 1.5 x LSN, INR < 1.3 (INR <3 en pacientes tratados con anticoagulantes), ALT y AST < 2.5 x LSN (< 5 x LSN en pacientes con metástasis hepáticas).
    12. Función renal adecuada demostrada por: creatinina sérica < 1.5 x LSN.
    13. Colesterol sérico en ayunas < 300 mg/dL o < 7.75 nmol/L y triglicéridos en ayunas < 2.5 x LSN. En caso de que uno de los dos o ambos umbrales sean excedidos, el paciente solo podrá ser incluido tras el inicio de medicación adecuada para disminuir los lípidos.
    14. Las mujeres en edad fértil deben poseer una prueba de embarazo sérica, negativa, en los 14 días anteriores a su inclusión en el estudio y/o una prueba de embarazo en orina, 48 horas antes de la primera administración del tratamiento del estudio.
    15. Obtención del consentimiento informado por escrito obtenido de acuerdo con la regulación local (antes de la realización de cualquier prueba específica del estudio).
    E.4Principal exclusion criteria
    1. Carcinoma neuroendocrino poco diferenciado, carcinoma endocrino de grado histológico alto, adenocarcinoide, carcinoide de células globet o carcinoma de células pequeñas.
    2. Haber recibido quimioterapia citotóxica, inmunoterapia o radioterapia, en las 4 semanas anteriores a la entrada del paciente en el estudio.
    3. Embolización de la arteria hepática en los últimos 6 meses (1 mes si existen otras áreas de enfermedad medible) o crioablación/ablación por radiofrecuencia de metástasis hepáticas en los 2 meses antes de la inclusión.
    4. Tratamiento anterior con inhibidores mTOR (sirolimus, temsirolimus, everolimus, deforolimus).
    5. Diabetes mellitus incontrolada definida como: glucosa sérica en ayunas > 1.5 x LSN.
    6. Pacientes con cualquier enfermedad grave y/o condición clínica incontrolada, como:
    - angina de pecho inestable, insuficiencia cardiaca congestiva sintomática, infarto
    de miocardio ocurrido 6 meses antes de la inclusión en el estudio, arritmia cardiaca importante e incontrolada,
    - infección grave activa o incontrolada,
    - cirrosis, hepatitis crónica active o hepatitis crónica persistente (excepto hepatitis B o C ver apartado 7.5.1-),
    - reducción importante de la función pulmonar demostrada mediante una espirometría y DLCO 50% o menos de lo normal y saturación de oxígeno del 88% o menos en reposo en la cámara de aire),
    - diatesis sangrante activa.
    7. Pacientes en tratamiento con fármacos considerados inhibidores o inductores potentes del isoenzima CYP3A (rifabutina, rifampicina, claritromicina, ketoconazol, itraconazol, voriconazol, ritonavir, telitromicina) en los 5 días inmediatamente previos al inicio del tratamiento del estudio (la lista de interacciones farmacológicas clínicamente relevantes se muestra en las tablas del apartado 6.5.1 de la sección de tratamientos concomitantes).
    8. Pacientes que están recibiendo tratamiento crónico con corticoesteroides u otro agente inmunosupresor.
    9. Pacientes con historia conocida de seropositividad VIH.
    10. Participación en cualquier otro ensayo clínico o tratamiento concomitante con otro fármaco en investigación.
    11. Presencia de cualquier otra malignidad excepto: cáncer de piel escamoso o epitelial tratado adecuadamente, cualquier otro cáncer in situ tratado adecuadamente, o cualquier otro cáncer que haya presentado el paciente en los últimos 3 años.
    12. Mujeres embarazadas o en estado de lactancia o adultos fértiles que no utilicen métodos anticonceptivos eficaces. Si se utilizan anticonceptivos de barrera, éstos se han de seguir utilizando durante todo el estudio por los dos sexos.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresión (SLP) a los 12 meses de tratamiento.
    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
    Pronostico
    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
    Cuando todos los pacientes hayan progresado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2011-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
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