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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2006-005644-92
    Sponsor's Protocol Code Number:MDA-STS-06
    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:2007-02-01
    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 number2006-005644-92
    A.3Full title of the trial
    ENSAYO CLÍNICO ABIERTO, NO ALEATORIZADO, PILOTO, EN FASE II, DE LA COMBINACIÓN DE IFOSFAMIDA Y DOXORRUBICINA LIPOSÓMICA SEGUIDO DE RADIOTERAPIA COMO TRATAMIENTO ANTINEOPLÁSICO NEOADYUVANTE EN PACIENTES CON SARCOMA DE PARTES BLANDAS DE EXTREMIDADES DE ALTO GRADO

    (OPEN CLINICAL TEST, NOT RANDOMIZED, PILOT, IN PHASE II, OF IFOSFAMIDA AND DOXORRUBICINA LIPOSÓMICA COMBINATION FOLLOWED OF X-RAY LIKE NEOADJUVANT TREATMENT ANTINEOPLÁSICO IN PATIENTS WITH SARCOMA OF SOFT PARTS OF EXTREMITIES OF HIGH DEGREE)
    A.4.1Sponsor's protocol code numberMDA-STS-06
    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 SponsorAntonio Cubillo Gracián (Servicio de Oncología Médica - Hospital MD Anderson)
    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 Doxorrubicina liposomal. En el protocolo, el tratamiento está definido por el principio activo (In protocol, treatment is defined only by active substance)
    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 nameDoxorrubicina Liposomal (doxorrubicine liposomal)
    D.3.4Pharmaceutical form Powder for 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 INNDCI: Doxorrubicina HCL
    D.3.9.1CAS number 25316-40-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    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 Doxorrubicina liposomal. Ifosfamida En el protocolo, el tratamiento está definido por el principio activo (In protocol, treatment is defined only by active substance)
    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 nameIfosfamida
    D.3.4Pharmaceutical form Powder for 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 INNIfosfamida (DCI)
    D.3.9.1CAS number 3778-73-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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
    PACIENTES CON SARCOMA DE PARTES BLANDAS DE EXTREMIDADES DE ALTO GRADO
    (PATIENTS WITH OF SOFT PARTS SARCOMA OF HIGH DEGREE EXTREMITIES)
    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
    Valoración de la eficacia del tratamiento combinado de ifosfamida y Doxorrubicina Liposómica en pacientes con sarcoma de partes blandas de extremidades de alto grado.

    ( Combined Liposomic Doxorrubicina and ifosfamida treatment effectiveness and valuation in patients with sarcoma of soft parts of extremities of high degree. )
    E.2.2Secondary objectives of the trial
    -Evaluar la supervivencia y la tolerabilidad de la combinación de ifosfamida y Doxorrubicina Liposómica seguida de radioterapia en pacientes con sarcoma de partes blandas de extremidades de alto grado.
    -Evaluar la respuesta tumoral a la radiología tras el tratamiento combinado de ifosfamida y doxorrubicina Liposómica.
    -Evaluar la cardio-seguridad de la combinación ifosfamida y doxorrubicina Liposómica.

    (- To evaluate survival and the tolerability combined liposomic doxorrubicin and ifosfamida treatment followed of x-ray in patients with sarcoma of soft parts of extremities of high degree.
    - To evaluate the tumorlike answer to radiology after the combined ifosfamida and liposomic doxorrubicin treatment.
    - To evaluate the cardio-security of combination ifosfamida and liposomic doxorrubicin treatment.)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) El consentimiento informado por escrito u oral ante testigos, antes de iniciar los procedimientos específicos del protocolo se debe obtener y documentar de acuerdo con los requisitos reglamentarios vigente.
    2) Pacientes con sarcoma de partes blandas de extremidades, histológicamente documentado de alto grado (G3 y G4), (T2X N0 M0). En función del tipo histológico y tamaño, se incluirán los:
     mayores de 5 cm: sarcoma sinovial, sarcomas neurogénicos, liposarcomas pleomórficos, liposarcomas desdiferenciados, sarcomas inclasificables.
     mayores de 10 cm: liposarcoma mixoide.
     El angiosarcoma, se incluirá independientemente de su tamaño en función de su contexto clínico.
    3) Pacientes con estudio de extensión negativo que incluya TAC o ecografía torácico-abdominal - pélvico.
    4) Pacientes en los que una resección compartimental sea inviable.
    5) Edad comprendida entre 18 - 65 años (ambos incluidos).
    6) Estado de actividad ECOG ≤1 o estado de actividad de Karnofsky 80 (Anexo 2)
    7) Función cardiaca normal confirmada mediante estudio de la FEVI con MUGA o electrocardiograma cuantitativo o ecocardiografía, dentro de los 14 días previos al inicio del tratamiento. Los valores deberán estar dentro de los valores de normalidad para el centro (habitualmente ≥ 50%).
    8) Requisitos de laboratorio (en los 14 días anteriores al registro)
    Hematología:
    Neutrófilos  2,0 x109/l
    Plaquetas  100 x109/l
    Hemoglobina  10 g/dl
    Función hepática:
    Bilirrubina total < 1x Límite Superior de la Normalidad (LSN).
    ASAT (SGOT) y ALAT (SGPT)  2,5 x LSN.
    Fosfatasa alcalina  2,5x LSN.

    Función renal:
    Creatinina  1 x LSN.
    Si los valores son límites, el aclaramiento de creatinina calculado debe ser 60 ml/min.
    9) Los pacientes deben estar accesibles para el tratamiento y el seguimiento. Los pacientes registrados en este ensayo deberán ser tratados y seguidos en el centro participante.
    10) Prueba de embarazo negativa (en orina o suero) durante los 14 días anteriores al registro en todas las mujeres con potencial de fertilidad.
    11) Las pacientes en edad fértil deberán tomar medidas anticonceptivas adecuadas durante su participación en el estudio, y hasta 3 meses después de la cirugía definitiva.
    E.4Principal exclusion criteria
    1) Pacientes con afectación neoplásica ganglionar y/o metastásica (cualquier N>0 y/o M>0)
    2) Quimioterapia sistémica anterior para el sarcoma de partes blandas.
    3) Terapia anterior con antraciclinas para cualquier neoplasia.
    4) Radioterapia anterior para el tumor primario, objeto del estudio
    5) Pacientes con sarcomas de células redondas pequeñas de alto grado (rabdomiosarcoma, sarcoma de Ewing, sarcomas desmoplásicos) ó leiomisarcoma.
    6) Pacientes embarazadas o en período de lactancia. Las pacientes con potencial de fertilidad deben utilizar anticonceptivos no hormonales adecuados durante el tratamiento del estudio y deben presentar un resultado negativo en la prueba de embarazo en orina o suero, realizada durante los 14 días anteriores al registro.
    7) Neurotoxicidad motora o sensorial preexistente de severidad  grado 2, según los criterios del NCI.
    8) Otras enfermedades o patologías médicas graves:
    - Insuficiencia cardiaca congestiva (clase III-IV de la NYAHA) o angina pectoris inestable, historia anterior de infarto de miocardio durante el año anterior a la inclusión en el estudio, hipertensión no controlada (presión arterial diastólica en reposo > 115mmHg) o arritmias no controladas de riesgo alto.
    - Antecedentes de trastornos neurológicos o psiquiátricos significativos, incluidos trastornos psicóticos, demencia o ataques que impedirían al paciente entender y otorgar el consentimiento informado.
    - Infección activa no controlada.
    - Úlcera péptica activa, diabetes mellitus inestable.
    - Disnea de reposo u oxigenoterapia crónica.
    9) Antecedentes o neoplasia actual distinta al sarcoma, a excepción de cáncer de piel no melanoma, carcinoma de cérvix uterino in situ u otro tipo de tumor tratados de forma curativa y sin indicios de enfermedad durante, al menos, diez años.
    10) Tratamiento crónico con corticosteroides, a menos que se haya iniciado > 6 meses antes de la inclusión en el estudio y a dosis bajas ( 20 mg de metilprednisolona o equivalente).
    11) Contraindicaciones para el uso de corticosteroides, antraciclinas, ovoderivados.
    12) Contraindicaciones para el uso de radioterapia.
    13) Tratamiento concomitante con otros fármacos en investigación. Participación en otro ensayo clínico con cualquier fármaco en investigación no comercializado durante los 30 días previos a la inclusión en el estudio.
    14) Tratamiento concomitante con cualquier otra terapia anticancerosa, o con otra medicación que pueda interferir con el tratamiento del estudio o con la acción del producto en estudio o confundir la evaluación de los resultados del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la respuesta a la quimioterapia previa a la cirugía y radioterapia.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 36
    F.4.2.2In the whole clinical trial 36
    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 Decision2007-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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