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    Summary
    EudraCT Number:2006-006079-19
    Sponsor's Protocol Code Number:RE05
    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:2010-01-04
    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 number2006-006079-19
    A.3Full title of the trial
    Ensayo clínico de fase III, aleatorizado, doble ciego, que compara sorafenib con placebo en pacientes con carcinoma primario de células renales extirpado que presentan riesgo elevado o medio de recidiva.
    A.3.2Name or abbreviated title of the trial where available
    SORCE
    A.4.1Sponsor's protocol code numberRE05
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN38934710
    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 SponsorMedical Research Council
    B.1.3.4CountryUnited Kingdom
    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 200 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER SCHERING PHARMA AG
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/207
    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 INNSORAFENIB TOSILATO
    D.3.9.3Other descriptive nameSORAFENIB TOSILATO
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Carcinoma de células renales
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10038407
    E.1.2Term Renal cell cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    SORCE trata de responder a dos objetivos. El primero es si al menos un año de
    tratamiento con sorafenib aumenta la supervivencia libre de enfermedad (SLE)
    comparado con placebo. El segundo hace referencia a la duración del tratamiento
    con sorafenib, es decir, si tres años de tratamiento aumentan la SLE comparado con
    un año.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios incluyen la supervivencia libre de metástasis (SLM:
    intervalo enre la aleatorización y la primera evidencia de metástasis o la muerte por
    CCR), el tiempo de supervivencia específico de CCR (tiempo transcurrido hasta la
    muerte por CCR), la supervivencia global (SG), la toxicidad y la corroboración de la puntuación pronóstica de Leibovich.
    En Reino Unido tiene también los siguientes objetivos secundarios adicionales:
    relación coste efectividad, características biológicas del CCR primario resecado (VHL,
    VEGFR2, FGF2, B-RAF, MEK, ERK).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - CCR confirmado histológicamente (se incluyen todo tipo de células de CCR, exceptunado el oncocitoma puro que se diferencia del CCR por presentar características oncocíticas). Sin evidencia de enfermedad macroscópica residual en el TAC postoperatorio tras la resección del CCR. Son elegibles los pacientes con tumores de células claras y con tumores de células no claras.
    - Pueden incluirse pacientes con un nódulo pulmonar, pero éste debe ser <5mm de diámetro y debe haber sido estable como mínimo 3 meses (confirmado por TAC).
    - Pacientes con riesgo medio o elevado por una puntuación de Leibovich de 3 a 11 (el anexo 1 presenta pautas anatomopatológicas especiales para la puntuación de Leibovich de las muestras tumorales).
    - Los sujetos deben tener una edad igual o superior a 18 años.
    - Mujeres en edad fértil con una prueba de embarazo negativa antes de la inclusión y que utilicen un método de anticoncepción adecuado tanto durante la fase de tratamiento del estudio como en los 9 meses siguientes. Las mujeres que estén en periodo de lactancia no son elegibles para el estudio
    - Función adecuada de la médula ósea (recuento de leucocitos >3,4 x 109/l, plaquetas >99 x 109/l), y de la función renal (creatinina <2,5 x LSN) y hepática (pruebas de función hepática <1,5 x LSN), en los 14 días anteriores a la aleatorización.
    - Los pacientes deben haberse sometido a la cirugía como mínimo 4 semanas y como máximo 3 meses (91 días) antes de la fecha del inicio del tratamiento.
    - Amilasa sérica <1,5 x LSN.
    - Tiempo de protrombina (PT) o INR (razón normalizada internacional) y tiempo de tromboplastina parcial (PTT) <1,5 x LSN.
    - Estado funcional de 0 ó 1, según la OMS (Anexo 2).
    - Obtención del consentimiento informado por escrito.
    E.4Principal exclusion criteria
    - Tratamiento anticanceroso previo para el CCR, diferente de la nefrectomía.
    - Arritmias cardíacas que requieran tratamiento con antiarrítmicos (se permite betabloqueantes y digoxina), isquemia o arteriopatía coronaria sintomática, infarto de miocardio en los 6 últimos meses, insuficiencia cardíaca congestiva > Clase II de la NYHA
    - Infecciones bacterianas o fúngicas graves clínicamente activas.
    - Antecedente conocido de infección por el virus de la inmunodeficiencia humana (VIH) o hepatitis crónica B o C.
    - Pacientes embarazadas o en periodo de lactancia. Las mujeres en edad fértil sin una prueba de embarazo negativa en los siete días anteriores al inicio del fármaco de estudio. Pacientes de ambos sexos con capacidad reproductiva que no utilicen métodos adecuados para el control de la natalidad.
    - Pacientes que hayan presentado alguna neoplasia con anterioridad (excepto carcinoma basocelular de piel tratado previamente y carcinoma in situ de cervix).
    - Pacientes que estén recibiendo tratamientos/productos concomitantes que presentan interacciones con sorafenib: rifampicina, zumo de pomelo, ritonavir, ketoconazol, itraconazol y la hierba de San Juan.
    - Pacientes con hipertensión no controlada
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la supervivencia libre de enfermedad (SLE), definido como el intervalo entre la aleatorización y la primera evidencia de recurrencia local o metástasis a distancia o la muerte por CCR.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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
    Investigación translacional
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El ensayo se considerará cerrado a efectos regulatorios después de que el último
    paciente reclutado haya completado el tratamiento del protocolo. El seguimiento de
    todos los pacientes incluidos en el ensayo continuará indefinidamente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    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 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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1600
    F.4.2.2In the whole clinical trial 1656
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Ver apartado 10.2 del protocolo.
    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 Decision2010-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-10
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