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    Summary
    EudraCT Number:2005-005064-80
    Sponsor's Protocol Code Number:SOGUG 06-01
    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:2005-12-27
    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 number2005-005064-80
    A.3Full title of the trial
    ENSAYO CLÍNICO DE FASE II PARA LA EVALUACIÓN DEL TRATAMIENTO DE SORAFENIB (BAY 43-9006) EN PACIENTES CON CARCINOMA DE CÉLULAS RENALES (CCR) NO RESECABLE Y/O METASTÁSICO NO ELEGIBLES O INTOLERANTES A INMUNOTERAPIA
    A.3.2Name or abbreviated title of the trial where available
    ESTUDIO SOGUG 06-01
    A.4.1Sponsor's protocol code numberSOGUG 06-01
    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 SponsorDR. JOAQUIM BELLMUNT MOLINS
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/207
    D.3 Description of the IMP
    D.3.1Product nameSorafenib
    D.3.2Product code BAY 43-9006
    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
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Carcinoma de células renales (CCR) medible, no resecable y/o metastásico con confirmación histológica y/o citológica.
    MedDRA Classification
    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 supervivencia libre de progresión (PFS) en los pacientes con carcinoma de células renales (CCR) no resecable y/o metastásico en tratamiento con BAY 43-9006.
    E.2.2Secondary objectives of the trial
    Conocer el tiempo libre de progresión con el tto en estudio.

    Conocer el tiempo de supervivencia global con el tto en estudio.

    Conocer la tasa de respuesta objetiva con el tto en estudio.

    Conocer la tasa de control de la enfermedad con el trto en estudio.

    Conocer el tiempo objetivo de respuesta (RC o RP) con el tto en estudio.

    Conocer la duración de la respuesta con el tto en estudio.

    Conocer la mejor respuesta global con el tto en estudio.

    Determinar la proporción de pacientes que presentan algún grado de reducción. tumoral aunque no lleguen a cumplir RECIST de respuesta parcial objetiva con el tto en estudio.

    Evaluar la seguridad y tolerabilidad del tratamiento.

    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Pacientes de edad igual o superior a 18 años.

    2. Pacientes con carcinoma de células renales de células claras (CCR) medible no resecable y/o metastático histológica o citológicamente documentado (excluyéndose los subtipos poco comunes) no elegibles o intolerantes a inmunoterapia.

    3. Pacientes con una esperanza de vida como mínimo superior a 12 semanas.

    4. Pacientes con riesgo intermedio o bajo según la puntuación de Motzer.

    5. Pacientes que tengan al menos una lesión evaluable en la TAC o RNM de acuerdo a criterios RECIST.

    6. Pacientes con un estado funcional 0 ó 1 según el ECOG.

    7. Pacientes con función hepática, renal, medular definida y coagulación adecuada, según los siguientes criterios:

    Bilirrubina total < 1’5 veces el límite superior de normalidad (LSN), ALT y AST < 2’5 veces el LSN (< 5 veces el LSN en caso de afectación hepática por el cáncer), Amilasa y lipasa < 1’5 veces el LSN, Creatinina sérica < 2 veces el LSN, TP o INR y TTP < 1’5 veces el LSN. En caso que el paciente reciba tratamiento con anticoagulantes, se realizará una monitorización estrecha con evaluaciones semanales, como mínimo, hasta que el INR sea estable, en base a una determinación antes de la administración de la dosis de acuerdo con los cuidados estándar locales.

    8. Pacientes que otorguen su consentimiento informado.

    9. Pacientes capaces de cumplir con los requisitos del estudio y sin impedimentos para seguir las instrucciones a lo largo del estudio.

    Los pacientes de ambos sexos deben usar métodos anticonceptivos de barrera apropiados (anticonceptivos orales o inyectables, dispositivo intrauterino, preservativo, esterilización) mientras participen en el protocolo. Después de la retirada del tratamiento con BAY 43-9006, los métodos anticonceptivos se deben utilizar durante 4 semanas en las mujeres, y durante 3 meses en los varones.

    E.4Principal exclusion criteria
    1. Pacientes que rechacen otorgar su consentimiento informado por escrito.

    2. Pacientes con subtipos poco comunes de CCR como tumor de células papilares puro, carcinoma de Bellini, carcinoma medular o tumores oncocíticos cromófobos y variantes sarcomatoides quedarán excluidos del estudio.

    3. Pacientes que hayan recibido tratamiento antiangiogénico previo.

    4. Pacientes que estén en tratamiento concomitante con cualquier otra terapia antineoplásica diferentes a la especificada.

    5.Pacientes con diagnóstico cáncer primario diferente de CCR excepto carcinoma cervical in situ, carcinomas basocelulares o tumores superficiales de vejiga, cáncer prostático pT1 gleason < 6 o otros tumores malignos que recibieron tratamiento curativo >5 años anteriores a la inclusión en el estudio.

    6. Antecedentes de arritmia cardíaca que requiera tratamiento con antiarrítmicos (excepto beta-bloqueantes o digoxina), enfermedad coronaria sintomática o isquemia (infarto agudo de miocardio en los seis meses anteriores) o insuficiencia cardíaca congestiva < clase II de la NYHA.

    7. Pacientes con procesos infecciosos activos bacterianos o fúngicos graves desde el punto de vista clínico (≥ grado 2 de los CTC del NCI, Versión 3).

    8. Pacientes que presenten serología positiva para el VIH previamente conocida o hepatitis B o C crónica.

    9. Antecedentes de aloinjerto de órgano.

    10. Meningitis carcinomatosa o enfermedad cerebral sintomática no controlada.

    11. Pacientes con trastornos convulsivos que requieren medicación (como antiepilépticos).

    12. Toda condición inestable o que podría poner en peligro la seguridad del paciente y/o su cumplimiento en el estudio

    13. Abuso de sustancias, condiciones clínicas, psicológicas o sociales que pudieran interferir con la participación del paciente en el estudio o con la evaluación de los resultados del estudio

    14. Pacientes que presenten alguna contraindicación o con sospecha de alergia al producto en investigación en estudio.

    15. Pacientes que estén participando o hayan participado en un ensayo clínico durante las 4 semanas previas a la inclusión.

    16. Pacientes embarazadas o en período de lactancia. Las mujeres en edad fértil deben tener un resultado negativo en la prueba de embarazo realizada en los siete días anteriores al comienzo de la administración de la medicación del estudio. Tanto los hombres como las mujeres incluidos en este estudio deben utilizar un método adecuado para el control de la natalidad.
    E.5 End points
    E.5.1Primary end point(s)
    Mediana de supervivencia libre de progresión (PFS) en los pacientes con carcinoma de células renales (CCR) no resecable y/o metastásico en tratamiento con BAY 43-9006.
    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 Information not present in EudraCT
    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 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) No
    E.8.2.2Placebo No
    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.8.5The 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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state27
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 27
    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 Decision2006-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-03
    P. End of Trial
    P.End of Trial StatusOngoing
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