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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2007-005395-14
    Sponsor's Protocol Code Number:MOT07/01
    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:2007-11-27
    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 number2007-005395-14
    A.3Full title of the trial
    EFECTO DE SORAFENIB SOBRE LA MODULACION DE LOS FACTORES SOLUBLES ANGIOGIOGÉNICOS EN PACIENTES CON CARCINOMA HEPATOCELULAR IRRESECABLE
    A.4.1Sponsor's protocol code numberMOT07/01
    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 SponsorRICARDO MORENO OTERO/MARIA CHAPARRO SANCHEZ
    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 AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/3/06/364
    D.3 Description of the IMP
    D.3.1Product namesorafenib
    D.3.2Product code BAY43-9006
    D.3.4Pharmaceutical form 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.3.9.1CAS number 284461-73-0
    D.3.9.2Current sponsor codeBAY 43-9006
    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 Yes
    D.3.11.13.1Other medicinal product typeihibidor multikinasa
    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 hepatocelular no resecable
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036706
    E.1.2Term Primary liver cancer non-resectable
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Determinar los efectos de Sorafenib sobre la angiogénensis o neovascularización; midiendo los cambios en los niveles séricos de VEGF, Flt-1, KDR; PDGF; PDGFR; Ang-1; Ang-2 y sTie2 y HGF
    E.2.2Secondary objectives of the trial
    •Evaluar la supervivencia libre de progresión
    •Perfil de Seguridad
    •Evaluar el índice de respuesta objetiva (RC/RP) y control del crecimiento tumoral (RC/RP/EE)
    •Evaluar el tiempo libre de progresión,
    •Evaluar el tiempo de supervivencia global.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Pacientes que otorguen su consentimiento informado por escrito antes de la realización de cualquier procedimiento específico del estudio en la visita de selección, entendiendo que el paciente tiene derecho a retirarse del estudio en cualquier momento sin perjuicio alguno.
    2.Pacientes hombres o mujeres con edad mayor de 18 años.
    3.Diagnóstico de Carcinoma Hepatocelular (CHC) confirmado por citología o histología en estadío avanzado no resecable.
    4.Cirrosis estadío A ó B de Child-Pugh. (10 pacientes grado A; 10 grado B).
    5.Esperanza de vida superior a 12 semanas.
    6.ECOG ≤ 2 (Karnofky ≥ 60).
    7.Enfermedad medible o evaluable por TAC con contraste o RMN
    8.Al menos una lesión medible según criterios RECIST (medición unidimensional).
    9.Ausencia de tratamiento antitumoral sistémico para el CHC
    10.Terapia local previa realizada al menos 4 semanas antes.
    11.Pacientes con una adecuada función hematológica definida como:
    Neutrófilos ≥ 1.5 x 109/L
    Plaquetas ≥ 60 x 109/L
    Hemoglobina ≥ 8.5 g/dl
    12.Pacientes con función hepática, renal, medular y de la coagulación adecuada, según los siguientes criterios:
    • Bilirrubina total <3 mg/dL
    • ALT y AST < 5 veces por encima del límite superior de normalidad
    • Amilasa y lipasa < 1.5 veces por encima del límite superior de normalidad
    • Creatinina sérica < 1.5 veces por encima del límite superior de normalidad
    • TP-INR < 2.3 veces or TP ≤6 segundos por encima del el límite superior de normalidad
    13.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.
    14.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.Antecedentes de arritmia cardiaca que requiera tratamiento con antiarrítmicos (excepto beta-bloqueantes o digoxina),
    2.Enfermedad coronaria sintomática o isquemia (infarto agudo de miocardio en los seis meses anteriores) o insuficiencia cardíaca congestiva > clase II de la NYHA.
    3.Pacientes con procesos infecciosos activos bacterianos o fúngicos graves desde el punto de vista clínico (≥ grado 2 de los CTC del NCI, Versión 3)
    4.Tumor del sistema nervioso central, incluída enfermedad metastásica cerebral.
    5.Infección conocida por el virus de la inmunodeficiencia humana (VIH).
    6.Fallo renal que requiera hemodiálisis o diálisis peritoneal.
    7.Historia de sangrado gastrointestinal clínicamente relevante en los 30 días previos a la entrada en estudio.
    8.Antecedentes de aloinjerto de órgano.
    9.Pacientes con convulsiones que requieran tratamiento.
    10.Pacientes incapaces de tragar medicación oral.
    11.Pacientes con diagnóstico de cáncer primario diferente de HC excepto carcinoma cervical in situ, carcinomas basocelulares o tumores superficiales de vejiga (Ta, Tis and T1), u otros tumores malignos que recibieron tratamiento curativo >3 años anteriores a la inclusión en el estudio.
    12.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.
    13.Pacientes que presenten alguna contraindicación o con sospecha de alergia al producto en investigación en estudio.
    14.Toda condición inestable o que podría poner en peligro la seguridad del paciente y/o su cumplimiento en el estudio.
    15.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.
    16.Cualquier tratamiento quimioterápico sistémico o utilización de un fármaco experimental para el tratamiento de CHC.
    17.Tratamiento antitumoral o inmunoterapia durante el estudio o dentro de las 4 semanas previas al comienzo del estudio.
    18.Radioterapia durante el estudio o en las tres semanas previas al comienzo del estudio. (Se acepta radioterapia paliativa)
    19.Cirugía mayor durante el estudio o en las 4 semanas previas al comienzo del estudio.
    20.Trasplante de médula autólogo o rescate con stem-cell en las 4 semanas previas al inicio del estudio.
    21.Utilización de modificadores de la respuesta biológica, tales como G-CSF, en las tres semanas previas a la entrada en estudio. Se acepta en el manejo de toxicidad aguda como neutropenia febril cuando esté clínicamente indicada a criterio del investigador; sin embargo, su uso no debe sustituir una posible reducción de dosis requerida Se acepta el uso de eritropoyetina en pacientes con tratamiento previo; siempre que no haya existido una modificación de la dosis en el mes previo al estudio o durante el estudio.
    22.Tratamiento con algún fármaco experimental fuera de este ensayo, durante las cuatro semanas previas a la entrada en el estudio.
    23.Exposición previa al fármaco en estudio.
    24.Toxicidad crónica no resuelta mayor de grado 2 según el Nacional Cáncer Institute common toxicity criteria (NCI) v3.0.
    25.Tratamiento concomitante con rifampicina o Hierba de San Juan.
    E.5 End points
    E.5.1Primary end point(s)
    Niveles séricos de VEGF, Flt-1, KDR; PDGF; PDGFR; Ang-1; Ang-2 y sTie2 y HGF
    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
    •Determinar los efectos de Sorafenib sobre la angiogénensis o neovascularización
    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 concerned4
    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 Information not present in EudraCT
    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
    Periodo de inclusión:12 meses desde la inclusión del primer paciente
    Periodo de seguimiento:12 meses desde la inclusión del último paciente
    Duración prevista del estudio: 24 meses
    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
    E.8.9.2In all countries concerned by the trial years2
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2008-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-14
    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
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