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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2007-003592-39
    Sponsor's Protocol Code Number:EFC10145
    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:2008-04-03
    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 number2007-003592-39
    A.3Full title of the trial
    “Estudio multinacional, randomizado, doble ciego controlado con placebo de AVE8062 (25 mg/m²) administrado cada 3 semanas, en pacientes con sarcoma de tejido blando en estadío avanzado tratado con cisplatino (75 mg/m²) después del fracaso de la quimioterapia con antraciclina e ifosfamida”.
    A.4.1Sponsor's protocol code numberEFC10145
    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 Sponsorsanofi-aventis recherche et développement
    B.1.3.4CountryFrance
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AVE8062
    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.3.9.1CAS number 253426-24-3
    D.3.9.2Current sponsor codeAVE8062 hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 mg/5mL
    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 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 CISPLATINO FERRER FARMA
    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 nameCISPLATINO FERRER FARMA
    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 INNcisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 mg/1 ml
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sarcoma de tejidos blandos en estadío avanzado tratado con cisplatino después del fracaso de la quimioterapia con antraciclina e ifosfamida.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la supervivencia libre de enfermedad (PFS) en los 2 brazos de tratamiento
    E.2.2Secondary objectives of the trial
    • Comparar la supervivencia global (OS) en los 2 brazos de tratamiento.
    • Comparar la tasa de respuesta objetiva (RR) en los 2 brazos de tratamiento.
    • Evaluar el perfil de seguridad de AVE8062 (en combinación con la terapia basal con cisplatino)
    • Evaluar la farmacocinética (PK) de AVE8062 y su principal metabolito, RPR258063, utilizando un enfoque poblacional, en todos los pacientes incorporados en centros seleccionados
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • STS histológicamente comprobado en el primer diagnóstico.
    • Pacientes con STS de estadio avanzado: STS localmente avanzado no resecable o STS metastásico
    • Fracaso de un régimen previo a base de antraciclina administrado a la dosis recomendada y de un tratamiento previo con ifosfamida
    • Progresión de la enfermedad dentro del mes previo a la randomización en el estudio
    E.4Principal exclusion criteria
    Relacionados con la metodología
    • Pacientes que no dan el l consentimiento informado firmado y fechado.
    • Ser menor de 18 años de edad
    • Estado de desempeño (PS) según un ECOG > 2
    • Expectativa de vida inferior a 12 semanas.
    • Metástasis cerebral y leptomeningitis carcinomatosa.
    • Más de dos regímenes previos de quimioterapia para enfermedad avanzada.
    • Quimioterapia intensiva previa con rescate autólogo de células madre
    • Tratamiento previo con Inhibidores de la tirosina quinasa (TKI) (agentes específicos o con múltiples objetivos)
    • Antecedentes de otro cáncer. Se permiten los cánceres de piel de células basales o células escamosas adecuadamente tratados, carcinoma in situ de cervix, o cualquier otro cáncer del hayan trascurrido más de 5 años y el paciente haya estado libre de enfermedad durante
    ese periodo.
    • Sólo lesiones previamente irradiadas (es decir, lesiones no evaluables) si no existen otras lesiones evaluables. Al comenzar el estudio, en caso de presentar una única lesión blanco metastásica, se deberá obtener prueba histológica o citológica de metástasis.
    • Mujeres embarazadas o en período de lactancia. Prueba de embarazo en suero u orina positiva en las mujeres antes de la randomización
    • Pacientes en edad fértil (M/F) que no estén de acuerdo con utilizar un método anticonceptivo aceptado y efectivo durante el período del tratamiento de estudio y durante un mínimo de 3 meses después de completar el tratamiento de estudio. La definición de “método anticonceptivo
    efectivo” se basará en el criterio del investigador. Las parejas de sexo femenino de
    los pacientes de sexo masculino deberán seguir los mismos métodos anticonceptivos mencionados
    anteriormente.
    • Período de lavado farmacológico de 3 semanas como mínimo desde la terapia antitumoral previa (quimioterapia, agentes específicos, y radioterapia) o cualquier tratamiento de investigación, excepto nitrosoureas, mitomicina C que no se pueden utilizar hasta 6 semanas antes de la fecha de randomización siempre que los pacientes no presenten signos residuales de toxicidad
    alguna.
    • Revisión inicial completa antes de las 3 semanas previas a la randomización del paciente.
    • Incapacidad del paciente para cumplir con las visitas programadas, los planes de tratamiento, análisis de laboratorio, y otros procedimientos del estudio.
    • Tratamiento concurrente con cualquier otra terapia anticancerígena, incluyendo quimioterapia,
    inmunoterapia, radioterapia, terapia dirigida, terapia genética, o pacientes que planean recibir estos tratamientos durante el estudio.
    • Otras enfermedades o condiciones clínicas graves como las indicadas, pero no estas exclusivamente:
    1. Infección activa.
    2. Síndrome de la vena cava superior.
    3. Enfermedad pulmonar obstructiva crónica (EPOC) grave y/o fibrosis pulmonar extensa (gases
    sanguíneos arteriales PAO2 < 60 u oximetría no invasiva SaO2 < 90).
    4. Derrame pericárdico que requiere intervención (drenaje).
    Relacionados con AVE8062
    • Paciente con valor de LVEF inferior al 50 % del límite inferior normal de la institución, evaluado por ecocardiografía, o por evaluación con radionúcleidos.
    • Evento isquémico dentro del año previo a ingresar al estudio, incluyendo, sin limitación: accidente cerebrovascular, angina de tórax, independientemente del lugar anatómico, diagnóstico de al menos una insuficiencia coronaria sintomática
    • Hipertensión no controlada
    • Arritmia no controlada, particularmente, trastorno severo del desarrollo como un bloqueo auriculoventricular de segundo o tercer grado
    • Tromboembolia que requiere anticoagulantes dentro de los últimos 6 meses
    Relacionados con cisplatino
    Función orgánica adecuada de acuerdo con lo siguiente:
    • Sangre medular: neutrófilos < 1.5 x 109 /L; plaquetas <100 x 109 /L
    • Función renal: creatinina > 1.5 mg/dl. Si el nivel de creatinina es ≥ 1.5 mg/dl, el aclaramiento de la creatinina calculado debería ser ≥ 60 ml/min (Apéndice B Fórmula
    de Cockroft-Gault).
    • Función hepática: Valor de bilirrubina total > límite normal; ALT/AST/AP ≥ 2.5 veces el límite superior normal según las normas de la institución. Un aumento del nivel de AP
    (≥ grado 2) se aceptaría sólo si este aumento está relacionado con la presencia de metástasis óseas.
    • Conocida hipersensibilidad al platino
    • Neuropatía periférica actual > grado 1 de acuerdo con la clasificación de CTCAE del NCI, de cualquier origen incluyendo los síntomas causados por el uso de medicación neurotóxicas (por ejemplo, vinca alcaloides, platino o taxanos).
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración primario de la eficacia es la supervivencia libre de enfermedad (PFS) definida como el intervalo de tiempo transcurrido desde la fecha de randomización hasta la fecha de aparición de la primera progresión objetiva del tumor documentada a nivel
    radiológico o muerte por cualquier causa, lo que sucediera primero.
    Un comité de revisión independiente (IRC) ciego respecto del grupo randomizado y de las características del paciente, evaluará la progresión radiológica objetiva del tumor.
    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 Yes
    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 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) 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 Yes
    E.8.2.3.1Comparator description
    All patients will be treated with cisplatin as background therapy
    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 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
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 300
    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 Decision2008-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-17
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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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