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    Summary
    EudraCT Number:2005-005026-31
    Sponsor's Protocol Code Number:EFC6125 [AVE0005A/3001]
    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:2006-03-02
    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 number2005-005026-31
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Effect of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites

    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos, del efecto de AVE0005 (VEGF Trap) intravenoso administrado cada 2 semanas en pacientes con cáncer de ovario avanzado con ascitis maligna sintomática recurrente
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberEFC6125 [AVE0005A/3001]
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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-Synthelabo Recherche, a subsidiary of sanofi-aventis group
    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 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 nameVEGF Trap
    D.3.2Product code AVE0005
    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.3.9.2Current sponsor codeAVE0005
    D.3.9.3Other descriptive nameVEGF Trap
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typedominios extracelulares del receptor VEGF humano fusionados con la porción Fc de la IgG1 humana
    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
    pacientes con cáncer de ovario avanzado con ascitis maligna sintomática recurrente
    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 el efecto de AVE0005 (VEGF Trap) frente al tratamiento con placebo en el tiempo hasta la repetición de la paracentesis (TRP) en pacientes con cáncer de ovario avanzado con ascitis maligna sintomática recurrente
    E.2.2Secondary objectives of the trial
    • Evaluar la seguridad y tolerabilidad general de AVE0005 (VEGF Trap) en pacientes con cáncer de ovario avanzado con ascitis maligna sintomática recurrente.
    • Comparar el efecto de AVE0005 (VEGF Trap) al tratamiento con placebo en la Medida del Impacto de Ascitis (AIM) y a los 60 días de frecuencia de paracentesis (FOP) en pacientes con cáncer de ovario avanzado con ascitis maligna sintomática recurrente.
    • Determinar si los anticuerpos humanos anti-AVE0005 (VEGF Trap) se desarrollan en pacientes con cáncer de ovario recurrente tratado con AVE0005 (VEGF Trap).
    • Establecer las propiedades psicométricas, incluyendo el constructo de validez, fiabilidad, y respuesta, del cuestionario (versión inglesa) de Medida del Impacto de Ascitis (AIM), y confirmar la validez de la portada y del contenido y las propiedades de medición de las versiones no inglesas del cuestionario AIM en pacientes con cáncer de ovario avanzado con ascitis maligna sintomática recurrente.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    •• Paciente con ascitis maligna sintomática, citológicamente confirmada (ICD-10 CM código C78.6) resultante de cáncer epitelial de ovario avanzado (incluyendo trompas de falopio y adenocarcinoma peritoneal primario) que hayan precisado al menos 2 paracentesis terapéuticas previas a una frecuencia de 1-4 paracentesis al mes para el control.
    • Enfermedad resistente a platino definida por recaída o progresión de la enfermedad durante o después del tratamiento, o intolerancia al fármaco.
    • Enfermedad resistente a topotecano y/o doxorubicina liposomal definida por recaída o progresión de la enfermedad durante o después del tratamiento, o intolerancia al fármaco.
    • Paciente a la que se realizó la paracentesis del Día 1 por síntomas de molestias, hinchazón, o dolor abdominal con eliminación ≥ 1 litro de líquido ascítico.
    • Paciente con un estado de actividad del Eastern Cooperative Oncology Group (ECOG) ≤ 2.
    E.4Principal exclusion criteria
    •• Que la paciente presente pseudomyxoma peritonei o mesotelioma periotoneal.
    • Que la paciente presente evidencias radiográficas de obstrucción intestinal (p.e., asas intestinales dilatadas acompañadas de niveles de aire-líquido) o perforación gastrointestinal (p.e., presencia de gas extraluminal) que precisa intervención quirúrgica.
    • Que la paciente presente asociada con ascitis transudativa (con frecuencia asociada con suero a gradiente de albúmina en ascitis >1,1), incluyendo pero no limitado a ascitis asociada con obstrucción mecánica, fallo cardiaco congestivo, pericarditis constrictiva, hipertensión portal, hipoproteinemia de insuficiencia hepática o síndrome nefrótico.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal será TRP definido como el número de días entre la fecha de aleatorización y la fecha de la primera paracentesis post-aleatorización. Para este criterio de valoración, se seguirá a cada paciente durante 6 meses, hasta la retirada del estudio, o hasta la primera paracentesis post-aleatorización, lo que suceda antes.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    detectar la inmunogenicidad tras exposición AVE005 validación psicométrica de la versión en inglés
    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) 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 Yes
    E.8.1.7.1Other trial design description
    el paciente podría recibir AVE0005 (VEGF Trap) después del Día 60 es decir, 60 días post-aleatorizac
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months10
    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 months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 54
    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 Decision2006-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-03
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