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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2008-006181-28
    Sponsor's Protocol Code Number:CRAD001LFR08
    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:2009-05-04
    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 number2008-006181-28
    A.3Full title of the trial
    RAPTOR: Estudio de fase II de RAD001, multicéntrico con un solo grupo como monoterapia para el tratamiento del carcinoma papilar avanzado de células renales
    A.4.1Sponsor's protocol code numberCRAD001LFR08
    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 SponsorNovartis Farmaceútica S.A.
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/449
    D.3 Description of the IMP
    D.3.1Product nameRAD001
    D.3.2Product code RAD0001
    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.3.9.1CAS number 159351-69-6
    D.3.9.2Current sponsor codeRAD001
    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.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 carcinoma renal papilar y metastático, que no hayan recibiendo tratamientos sistémicos previos. Este estudio internacional, en varios centros, contará con un máximo de 60 pacientes en un periodo aproximado de 12 meses.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de RAD001 como monoterapia en el tratamiento de cánceres renales papilares. La eficacia se mide en función del porcentaje de pacientes libres de progresión a los 6 meses.
    E.2.2Secondary objectives of the trial
    Evaluar la tasa de respuesta, la duración de la respuesta, el índice de control de la enfermedad, la supervivencia media libre de progresión y la supervivencia total en este grupo de pacientes, y definir con mayor precisión el perfil de seguridad de RAD001.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 años de edad o más.
    2. Pacientes con diagnóstico histológico de carcinoma de células renales papilar y metastático, de tipo I o II, confirmado por la unidad central (se deben enviar las muestras pertinentes -y los bloques de parafina si los hay- a la unidad central para su evaluación en el plazo de un mes a partir del reclutamiento: si esto no es factible, el paciente quedará descartado).
    3. Pacientes con al menos una lesión mensurable en el análisis basal según los criterios de RECIST
    4. Pacientes cuya calificación según el ECOG sea de menor o igual a 1
    5. Función medular adecuada, según la siguiente fórmula: RAN mayor o igual a 1,5 x 109/L, Plaquetas mayor o igual a 100 x 109/L, Hb >9 g/dL.
    6. Función hepática adecuada, según la siguiente fórmula: bilirrubina sérica: menor o igual a 1,5 x LSN, RIN< 1,3 (o <3 con anticoagulantes), ALT y AST menor o igual a 2.5x LSN. Para pacientes con metástasis de hígado conocidas: AST y ALT menor o igual a 5x LSN.
    7. Función renal adecuada, según la siguiente fórmula: creatinina sérica menor o igual a 2,0 x LSN.
    8. Esperanza de vida mayor o igual a 3 meses
    9. Colesterol sérico en ayunas menor o igual a 200 mg/dL o menor o igual a 5 mmol/L y triglicéridos en ayunas menor o igual a 200 mg/dL. NOTA: en caso de que se supere uno de estos umbrales, o ambos, sólo se podrá incluir al paciente una vez que haya empezado a tomar la medicación pertinente para la reducción de lípidos.
    10. Las mujeres en edad de gestación deberán demostrar resultados negativos en una prueba de embarazo en orina una semana antes de comenzar el tratamiento del estudio.
    11. Pacientes que den su autorización, con pleno conocimiento y por escrito, según las directrices locales.
    E.4Principal exclusion criteria
    1. Pacientes que se hayan sometido a tratamiento de radiación durante los 28 días anteriores al tratamiento del estudio (se permite la radioterapia paliativa para lesiones óseas durante las dos semanas anteriores al inicio del tratamiento).
    2. Pacientes que hayan recibido previamente tratamientos sistémicos contra el CCR metastático, como sunitinib, sorafenib y bevacizumab.
    3. Pacientes que hayan recibido previamente inhibidores de la mTOR (sirolimús, temsirolimus, everolimus).
    4. Pacientes con hipersensibilidad conocida a RAD001 (everolimus), a otras rapamicinas (sirolimús, temsirolimus) o a sus excipientes.
    5. Pacientes con metástasis no controladas en el sistema nervioso central.
    6. Pacientes que reciban tratamiento sistémico crónico con corticosteroides (dosis equivalente a mayor o igual 10 mg/día de metilprednisolona) u otro agente inmunosupresor. Los esteroides inhalados y tópicos son aceptables, así como la opoterapia, tras la extracción de la glándula suprarrenal bilateral.
    7. Pacientes con historial conocido de seropositividad al VIH.
    8. Pacientes con hepatitis autoinmune.
    9. Pacientes con diatesis activa sangrante.
    10. Pacientes con trastornos médicos graves o incontrolados, o bien con otros trastornos que pudieran afectar a su participación en el estudio, tales como los siguientes:
    angina de pecho inestable, insuficiencia cardiaca congestiva sintomática (NYHA II, III, IV), infarto de miocardio menor o igual 6 meses antes del primer tratamiento del estudio, arritmia cardiaca grave e incontrolada.
    deterioro grave de la función pulmonar, comprobada mediante espirometría y DLCO (hasta el 50% del valor previsto normal) o saturación de O2 (88% o menos en reposo con aire ambiente)
    diabetes incontrolada, en la que la glucosa sérica en ayunas sea >2,0x LSN
    cualquier infección o trastorno activo (agudo o crónico) o incontrolado que impida evaluar al paciente o que impida al paciente finalizar el estudio
    enfermedades médicas no malignas y no controladas o cuyo control pueda peligrar a causa del tratamiento de este estudio, como una hipertensión grave no controlada mediante tratamiento médico o anomalías tiroideas que no se puedan rectificar con ayuda de medicación
    enfermedades hepáticas, como cirrosis, cirrosis descompensada, hepatitis activa crónica o hepatitis crónica persistente
    trastornos isquémicos y autoinmunes que pongan en peligro la vida del paciente
    11. Pacientes en cuyo historial figure otra malignidad primaria que no hayan recibido tratamiento por un periodo de menor o igual 3 años, salvo los que sufran cáncer de piel no melanoma y carcinomas del cuello uterino.
    12. Mujeres embarazadas o en periodo de lactancia, o mujeres adultas en edad de gestación que no utilicen métodos efectivos de control de la natalidad. Si cualquier paciente, del sexo que sea, utiliza anticonceptivos de barrera, deberá continuar utilizándolos mientras dure el estudio. Los anticonceptivos orales no son aceptables
    13. Pacientes que utilicen otros agentes en investigación o que hayan recibido fármacos en investigación menor o igual a 4 semanas antes del inicio del tratamiento del estudio.
    14. Pacientes que no quieran o no puedan ajustarse al protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes libres de progresión a los 6 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    LPLV
    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 months9
    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 months9
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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 Decision2009-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-23
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