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    Summary
    EudraCT Number:2008-005872-29
    Sponsor's Protocol Code Number:MORAb-003-004
    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:2009-04-20
    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 number2008-005872-29
    A.3Full title of the trial
    Estudio clínico de fase III randomizado, doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de farletuzumab (MORAb-003) administrado semanalmente en combinación con carboplatino y taxano en pacientes con cáncer de ovario sensible a platino en primera recidiva

    A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse
    A.4.1Sponsor's protocol code numberMORAb-003-004
    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 SponsorEisai Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/535
    D.3 Description of the IMP
    D.3.1Product nameFarletuzumab
    D.3.2Product code MORAb-003
    D.3.4Pharmaceutical form Intravenous 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 INNFarletuzumab
    D.3.9.1CAS number 896723-44-7
    D.3.9.2Current sponsor codeMORAb-003
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 5.5
    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 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 placeboIntravenous 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
    Primera recidiva del cáncer de ovario epitelial no mucinoso sensible a platino, incluyendo los tumores malignos primarios peritoneales o de trompas de Falopio.

    First relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer recurrent
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el efecto de dos dosis de MORAb-003 o placebo en combinación con carboplatino y un taxano sobre la supervivencia libre de progresión (SLP), determinada de acuerdo con los criterios RECIST, en pacientes con cáncer de ovario sensible a platino en primera recidiva.
    E.2.2Secondary objectives of the trial
    - Evaluar el efecto de MORAb-003 sobre la SG
    - Evaluar el efecto de MORAb-003 sobre la SLP definida por CA-125 y la respuesta serológica, basándose en los criterios de Rustin
    - Determinar si MORAb-003 produce una 2ª remisión más prolongada que la 1ª
    - Evaluar el efecto de MORAb-003 sobre el índice de mejor RO, el TR y la DR, de acuerdo con criterios RECIST
    - Comparar la respuesta serológica entre la dosis baja (1,25 mg/kg) y alta (2,5 mg/kg) de MORAb-003, ambas en combinación con un carboplatino y un taxano, y con placebo en combinación con carboplatino y un taxano
    - Evaluar la seguridad y la tolerancia de las dos dosis de MORAb-003
    - Evaluar el efecto de MORAb-003 sobre la CV valorada por las pacientes
    - Evaluar el efecto de MORAb-003 sobre la utilización de recursos
    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 FARMACOCINÉTICO EN ASOCIACIÓN CON EL ESTUDIO MORAb-003-004:
    - Determinar si existe una interaccion farmacocinética entre MORAb-003 y carboplatino, paclitaxel o docetaxel en un subestudio FC de interacciones farmacológicas (DDI).

    SUBESTUDIO FARMACOGENÓMICO EN ASOCIACIÓN CON EL ESTUDIO MORAb-003-004:
    - Análisis de ADN genómico, muestras de suero o tejido tumoral de archivo para identificar marcadores moleculares que puedan predecir la respuesta a la inmunoterapia.
    E.3Principal inclusion criteria
    1. Ser mujer > ó = 18 años de edad
    2. Las pacientes potencialmente fértiles deben estar esterilizadas quirúrgicamente o deben comprometerse a utilizar un método anticonceptivo médicamente aceptable durante todo el período del estudio. Las medidas anticonceptivas deben empezar a aplicarse antes de o en el período de selección y deben continuar utilizándose durante todo el período del estudio y hasta 2 meses después de la administración de la última dosis del fármaco del estudio. Las mujeres embarazadas y/o en período de lactancia no podrán ser incluidas en el estudio.
    3. Diagnóstico de cáncer de ovario epitelial no mucinoso, incluyendo tumores malignos primarios peritoneales o de trompas de Falopio, confirmado histológica o citológicamente
    4. Deben presentar enfermedad medible en TAC o RM
    5. Deben haber experimentado recidiva, confirmada radiológicamente, > ó = 6 y < 24 meses después de haber completado la quimioterapia con platino/taxanos en primera línea
    6. Deben ser candidatas a recibir tratamiento repetido con carboplatino/taxanos
    7. Esperanza de vida de > ó = 6 meses, estimada por el investigador
    8. Si las pacientes presentan otras patologías médicas significativas, éstas deben estar bien controladas y estabilizadas, de acuerdo con la opinión del investigador, como mínimo desde los 30 días previos al día 1 del estudio
    9. Estado funcional de Karnofsky (EFK) > ó = 70%
    10. Deben presentar los resultados de laboratorio y clínicos siguientes en las 2 semanas previas al día 1 del estudio:

    Recuento absoluto de neutrófilos (RAN) > ó = 1,5 x 10*9/l
    Recuento de plaquetas > ó = 100 x 10*9/l
    Hemoglobina > ó = 9 g/dl
    Creatinina < ó = 1,5 x LSN (grado 1 CTCAE)
    Bilirrubina < 1,5 x LSN (grado 1 CTCAE)
    Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) y fosfatasa alcalina < 2,5 x LSN (grado 1 CTCAE)

    11. Función neurológica: neuropatía (sensitiva y motora) < ó = grado1 CTCAE
    12. Las pacientes deben otorgar el consentimiento informado por escrito y ser capaces de cumplir los procedimientos del protocolo
    E.4Principal exclusion criteria
    1. No haber respondido nunca a tratamiento en primera línea basado en platino o haber experimentado una primera recidiva <6 ó >24 meses después de completar el último tratamiento con platino
    2. Haber recibido otros tratamientos para el cáncer de ovario desde la recidiva
    3. Afectación tumoral del sistema nervioso central (SNC) conocida
    4. Evidencia de otras neoplasias invasivas activas que han requerido tratamiento en los 5 últimos años
    5. Cardiopatías clínicamente significativas (p. ej. insuficiencia cardíaca congestiva clase 3 ó 4, de acuerdo con la New York Heart Association, o angina de pecho mal controlada con medicación o infarto de miocardio en los 6 meses previos)
    6. Arritmias clínicamente significativas demostradas en el electrocardiograma (ECG) (Nota: las pacientes con arritmia auricular crónica, es decir, fibrilación auricular o taquicardia supraventricular paroxística [TSP] podrán participar en el estudio)
    7. Enfermedad sistémica grave activa, incluyendo infecciones bacterianas o micóticas activas
    8. Infección activa por el virus de la hepatitis o de inmunodeficiencia humana (VIH). Las pacientes con serología positiva que sean asintomáticas no serán excluidas del estudio por tal motivo.
    9. Tratamiento concomitante con otro tipo de inmunoterapia (p. ej. inmunosupresores o tratamiento crónico con corticosteroides sistémicos, aunque está permitida la administración de dosis bajas de corticosteroides)
    10. Reacción alérgica conocida a un tratamiento previo con anticuerpos monoclonales o HAHA documentados
    11. Tratamiento previo con MORAb-003 (farletuzumab)
    12. Contraindicaciones clínicas al tratamiento con un taxano
    13. Tratamiento previo con cualquier agente en investigación en las 4 semanas previas a la inclusión en el estudio
    14. Mujeres en período de lactancia, embarazadas o con probabilidad de quedarse embarazadas durante el estudio
    E.5 End points
    E.5.1Primary end point(s)
    La supervivencia libre de progresión (SLP) es la variable de eficacia principal del estudio y se define como el tiempo transcurrido desde la randomización hasta que se manifiesta progresión de la enfermedad, de acuerdo con los criterios RECIST (se determinará mediante la revisión independiente de las evaluaciones con TAC/RM, conforme se describe en las Normas Centrales de Radiología y el Plan de Análisis Estadístico), o se produce la muerte por cualquier causa.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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 years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 900
    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 Decision2009-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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