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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2007-000509-31
    Sponsor's Protocol Code Number:206-OC-202
    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:2007-07-10
    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 number2007-000509-31
    A.3Full title of the trial
    Estudio en fase 1/2, abierto, adaptativo, aleatorio de doxorrubicina liposómica con o sin M200 (volociximab) para el tratamiento de pacientes con cáncer de ovario epitelial avanzado o cáncer peritoneal primario que han recaído después de una terapia previa con una quimioterapia basada en platinos / taxanos.

    A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy
    A.4.1Sponsor's protocol code number206-OC-202
    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 SponsorBiogen Idec Ltd
    B.1.3.4CountryUnited Kingdom
    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.3.1Product namevolociximab
    D.3.2Product code M200
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvolociximab
    D.3.9.2Current sponsor codeM200
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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 Caelyx
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical 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 drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdoxorubicin hydrochloride
    D.3.9.1CAS number 25316409
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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
    Cáncer de ovario epitelial avanzado o cáncer peritoneal primario

    Advanced epithelial ovarian cancer or primary peritoneal cancer
    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 eficacia de volociximab en combinación con doxorrubicina liposómica en cáncer de ovario epitelial avanzado o cáncer peritoneal primario
    • Evaluar la seguridad y tolerabilidad de volociximab en combinación con doxorrubicina liposómica
    E.2.2Secondary objectives of the trial
    •Evaluar la farmacocinética (PK) de volociximab en combinación con doxorrubicina liposómica.
    •Evaluar los beneficios en la calidad de vida (QoL) de de volociximab en combinación con doxorrubicina liposómica.

    Adicionales:
    •Evaluar la actividad farmacodinámica de volociximab a través de estudios de los biomarcadores proteínicos en suero.
    •Investigar la posible relación entre la expresión tumoral de α5β1 u otros biomarcadores relevantes y la respuesta clínica a volociximab.
    •Medir volociximab y posiblemente otros biomarcadores proteínicos en el líquido ascítico obtenido de las pacientes a las que se pueda realizar una paracentesis segura e investigar la posible correlación con la respuesta clínica a volociximab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Las pacientes deberán otorgar su consentimiento informado por escrito y cualquier autorización que requiera la legislación nacional (por ejemplo, información sanitaria protegida [PHI]).

    2)Mujeres con una edad ≥ 18 años en el momento de la obtención del consentimiento informado.

    3)Enfermas con un cáncer de ovario epitelial o cáncer peritoneal primario (excluyendo histologías pequeñas de células redondas) avanzado (Estadio III o IV) histológicamente documentado.

    4)Pacientes con una enfermedad recurrente o persistente

    5)Pacientes que no hayan recibido más de 2 tratamientos antineoplásicos previos. Al menos uno de los tratamientos deberá haber estado compuesto de platinos o taxanos (carboplatino, cisplatino u otro compuesto organoplatino). Si se administra el mismo régimen más de una vez, sólo se contará como un régimen. Asimismo, si los componentes de un régimen se administran más de una vez usando la misma pauta, sólo contará como un régimen.

    6)Pacientes con una enfermedad mensurable según RECIST, o una enfermedad evaluable (es decir, sólo lesiones no-diana).

    7)Pacientes con un Estado General según ECOG ≤1.

    8)Pacientes con una expectativa de vida > 12 semanas

    9)Las mujeres fértiles deberán estar dispuestas a usar un método anticonceptivo efectivo durante el estudio y continuar usando el anticonceptivo durante, al menos, 6 meses tras su última dosis de tratamiento del estudio (alrededor de 5 semi-vidas).
    E.4Principal exclusion criteria
    1)Enfermas con valores analíticos superiores o inferiores a los límites indicados a continuación:

    •Cifras de granulocitos < 1500/µL
    •Cifras de plaquetas < 75.000/µL
    •Hemoglobina < 8.5 g/dL (la hemoglobina puede estar apoyada por transfusión o eritropoyetina u otros factores de crecimiento hematopoyético aprobados; se permite el uso de darbopoyetina [Aranesp®[).
    •Bilirrubina sérica > 2.0 x límite superior de la normalidad (LSN)
    •AST y ALT > 2.5 x LSN (ST y ALT > 5 x LSN para pacientes con metástasis hepáticas)
    •Creatinina sérica > 2.0 mg/dL
    •Cociente Internacional Normalizado (INR) > 1.5
    •Tiempo de tromboplastina parcial activada (TTPa) > 1.5 x LSN.

    2)Pacientes con angina inestable o antecedentes de infarto de miocardio en los 6 meses previos al Día 1.

    3)Pacientes con una insuficiencia cardíaca congestiva de grado ≥ II del New York Heart Associaton (NYHA).

    4)Pacientes que hayan recibido un tratamiento previo con una antraciclina (liposómica) o antracenediona.

    5)Pacientes que hayan recibido cualquier terapia antineoplásica experimental en las 6 semanas previas al Día 1.

    6)Pacientes que hayan recibido cualquier terapia antineoplásica no experimental en las 4 semanas previas al Día 1.

    7)Pacientes que hayan recibido cualquier tratamiento previo con agentes anti-angiogénicos.

    8)Pacientes que estén tomando agentes inmunomoduladores concomitantes, incluidos pero no limitados a, interferones, interleuquinas, esteroides sistémicos, ciclosporina, tacrolimus, inhibidores de calcineurina, metotrexato crónico a bajas dosis o azatioprina (se permite el uso de esteroides inhalados o intranasales o esteroides orales a una dosis ≤10 mg/día de prednisona o su equivalente).

    9)Pacientes que requieran tratamiento con un anticoagulante con la excepción de la Aspirina® a bajas dosis (≤81 mg/día), warfarina ((≤1 mg/día) o heparina para mantener la permeabilidad del catéter IV.

    10)Pacientes con una fracción de eyección ventricular izquierda (FEVI) < 50%.

    11)Pacientes con antecedentes de ictus o ataque isquémico transitorio en los 6 meses previos al Día 1.

    12)Pacientes con una enfermedad vascular periférica clínicamente significativa

    13)Pacientes con evidencia de diatesis hemorrágica o coagulopatía. (Nota: un antecedente de trombosis venosa profunda no impedirá que las pacientes que participen en el estudio).

    14)Pacientes con antecedentes de fístula abdominal, perforación gastrointestinal o absceso intra-abdominal en los 6 meses previos al Día 1.

    15)Pacientes con heridas que no cicatrizan, úlceras o fracturas óseas graves

    16)Pacientes con evidencia de una enfermedad autoinmune, incluida aunque no limitada a colitis ulcerativa, enfermedad de Crohn, artritis reumatoide, lupus eritematoso sistémico, esclerodermia, y otra enfermedad en la que la función inmunológica o la competencia inmunológica esté deteriorada.

    17)Pacientes con una infección activa que requiera antibióticos, antivíricos o antifúngicos sistémicos, incluida el VIH/SIDA, infección por hepatitis B o C.

    18)Pacientes con antecedentes de trastornos linfoproliferativos

    19)Pacientes con anticuerpos anti-murinos humanos (HAMA) y/o anticuerpos anti-quiméricos humanos (HACA).

    20)Pacientes con metástasis conocidas en el sistema nervioso central o en el cerebro.

    21)Pacientes con antecedentes de otros procesos malignos en los 3 años previos al Día 1, excepto un carcinoma in situ del cuello uterino, carcinoma ductal in situ (DCIS) de la mama, o cáncer cutáneo basocelular o escamocelular tratados adecuadamente.

    22)Pacientes embarazadas (test de embarazo positivo) o en periodo de lactancia.

    23)Pacientes incapaces de cumplir con los procedimientos del estudio y de seguimiento.

    24)Pacientes con cualquier otra enfermedad, trastorno metabólico, dato de la exploración física o dato analítico que, en opinión del investigador, proporcione una sospecha razonable de una enfermedad o afección que contraindique el uso de un fármaco experimental o que pueda afectar a la interpretación de los resultados o poner a la paciente en un alto riesgo de sufrir complicaciones por el tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia sin progresión
    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 Yes
    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
    Evaluación de la Calidad de Vida
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cuidados estándar
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 No
    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 state
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    El tratamiento continuará hasta la progresión de la enfermedad. En ese momento el paciente y el médico hablarán sobre otras opciones de tratamiento disponibles.

    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 Decision2007-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-20
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