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    Summary
    EudraCT Number:2008-008922-55
    Sponsor's Protocol Code Number:GEIS20
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-03-23
    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 number2008-008922-55
    A.3Full title of the trial
    ENSAYO FASE II ALEATORIZADO, ABIERTO, MULTICÉNTRICO Y PROSPECTIVO DE DOXORRUBICINA vs TRABECTEDINA Y DOXORRUBICINA EN PRIMERA LÍNEA DE PACIENTES CON SARCOMA DE PARTES BLANDAS AVANZADOS NO OPERABLES Y/O METASTÁSICOS
    A.4.1Sponsor's protocol code numberGEIS20
    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 Investigación en Sarcomas
    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 YONDELIS 0,25 mg polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMA MAR, S.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameYondelis
    D.3.2Product code 07417001
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRABECTEDINA
    D.3.9.3Other descriptive nameTRABECTEDINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 RoleComparator
    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 nameDoxorrubicina
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDoxorrubicina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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: 3
    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 nameDoxorrubicina
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDoxorrubicina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    Sarcoma de partes blandas avanzados no operables y/o metastásicos
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la eficacia de la combinación de trabectedina y doxorrubicina en comparación con doxorrubicina sola en pacientes con Sarcomas de Partes Blandas (SPB) avanzados no operables y/o metastásicos
    E.2.2Secondary objectives of the trial
    - Determinar la actividad por medio de la respuesta objetiva según RECIST de la combinación trabectedina/ doxorrubicina y del brazo control.
    - Determinar la proporción de control tumoral (respuestas más estabilizaciones) en ambas ramas de tratamiento.
    - Supervivencia global.
    - Determinar la actividad en cambios tisulares extrapolando los criterios de Choi a SPB. (Ver estudio de revisión radiológica asociado)
    - Determinar la toxicidad de la combinación trabectedina/ doxorrubicina y del brazo control.
    - Determinar expresividad protéica y de RNAm de genes que podrían estar implicados en un perfil de respuesta más favorable o de resistencia respecto a los fármacos objeto de estudio para analizar el impacto pronóstico de los mismos en los parámetros de actividad definidos (Ver estudio traslacional asociado).
    - La evaluación de la inestabilidad génica, así como la expresividad proteica que podría condicionar respuesta/resistencia a los fármacos objeto de estudio será correlacionada con varia
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subestudio molecular
    Se requieren dos tipos de muestras:

    1. Tejido fijado e incluido en parafina obtenida al diagnóstico necesario para la revisión histológica, el estudio inmunohistoquímico, de inestabilidad genética y de expresión de mRNA.
    2. Sangre periférica, 7 ml de sangre en tubos de EDTA para la obtención de ADN constitutivo para el estudio de inestabilidad génica y polimorfismos.
    E.3Principal inclusion criteria
    -El paciente debe firmar voluntariamente el consentimiento informado antes de la realización de cualquier prueba del ensayo que no forme parte de la atención habitual de los pacientes, con el conocimiento por parte del paciente que puede abandonar el ensayo en el momento que quiera, sin que se vea perjudicado en ningún momento su atención posterior.
    -Edad superior a 18 años y menor de 70 años.
    - Diagnóstico histológico de sarcoma de partes blandas no operables y/o metastásicos.
    -Son incluibles los siguientes tipos histológicos:
    § sarcoma pleomórfico indiferenciado (antiguo histiocitoma fibroso maligno)
    § leiomiosarcoma
    § angiosarcoma
    § liposarcoma
    § sarcoma sinovial
    § fibrosarcoma
    § hemangiopericitoma
    § sarcoma neurogénico
    § mixofibrosarcoma
    § sarcoma no clasificable
    - Enfermedad medible, de acuerdo con los criterios RECIST.
    -Estado funcional 0-2 (ECOG).
    -Función medular basal adecuada (hemoglobina > 10 g/dL, leucocitos &#8805; 3.000/mm3, neutrófilos &#8805; 1.500/mm3, plaquetas &#8805; 100.000/mm3). Son aceptables pacientes con alteración de las transaminasas &#8804; 2,5 veces los LSN , bilirrubina total &#8804; LSN, CPK&#8804; 2.5 veces los LSN, Fosfatasa alcalina &#8804; 2,5 veces más los LSN. (Si la elevación es > 2,5 veces el LSN, entonces la fracción hepática de la fosfatasa alcalina y/o de la 5’ nucleotidasa y/o la GGT deben ser &#8804; LSN) , ó cifras de creatinina &#8804; 1,6 mg/dL.
    -Los pacientes en edad fértil (tanto los varones como las mujeres) deben usar un método eficaz anticonceptivo antes de la entrada en el estudio y durante la realización del estudio. Además, las mujeres deben mantener las medidas anticonceptivas hasta 6 meses después de finalizar el tratamiento mientras que los varones deben prolongar estas medidas hasta 6 meses después del tratamiento. Debe descartarse embarazo mediante prueba de orina (test de embarazo negativo) para la inclusión en el estudio.
    -Funcionalidad cardíaca (FEVI) normal, considerando los rangos normales de la institución.
    E.4Principal exclusion criteria
    -Pacientes que hayan recibido quimioterapia previamente.
    -Pacientes que hayan sido irradiados en la/s única localización/es de enfermedad tumoral medible/s.
    -Estado funcional > 2 (ECOG).
    -Metástasis en el SNC.
    -Cifras de bilirrubina superior al nivel normal.
    -Creatinina superior a 1,6 mg/dL.
    -Antecedentes de otra enfermedad neoplásica con excepción de basalioma o carcinoma in situ de cérvix adecuadamente tratados.
    -Enfermedades cardiovasculares graves (Disnea >= 2 NYHA p.ej.).
    -Patologías sistémicas de base que limiten la supervivencia a menos de 2 años, que limiten la disponibilidad del paciente, o que puedan, a juicio clínico, interferir de forma significativa con la toxicidad del tratamiento.
    -Enfermedades infecciosas bacterianas, víricas o micóticas no controladas.
    -Pacientes embarazadas o lactantes.
    -Situaciones psicológicas, familiares, sociológicas o geográficas que no permitan el cumplimiento del protocolo o del consentimiento informado.
    -Pacientes que estén actualmente en otro ensayo clínico o recibiendo cualquier agente en investigación.
    -Pacientes que hayan participado en un ensayo clínico y/o hayan recibido un agente en investigación en los 30 días anteriores a la inclusión.
    -Las siguientes histologías serán excluidas: -Rabdomiosarcoma
    -Tumores de la familia de Ewing
    -Tumor desmoplásico de célula redonda.
    -Sarcoma de células claras
    -Sarcoma Alveolar
    E.5 End points
    E.5.1Primary end point(s)
    SLP: se calculará como el tiempo desde la fecha de aleatorización hasta la fecha de progresión de la enfermedad o muerte (independientemente de la causa de ésta).
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned25
    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 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 desde el punto de vista normativo después de que los datos sobre supervivencia global estén lo suficientemente preparados como para su publicación inicial. Las observaciones de seguimiento de las pacientes incluidas en el ensayo se pueden mantener de forma indefinida.
    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 months0
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Varones en Edad Fértil que utilicen medidas anticonceptivas
    F.4 Planned number of subjects to be included
    F.4.1In the member state182
    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 Decision2009-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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