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    Summary
    EudraCT Number:2010-018478-19
    Sponsor's Protocol Code Number:GEICO-1001
    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:2010-03-30
    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 number2010-018478-19
    A.3Full title of the trial
    Ensayo fase II para evaluar la eficacia y seguridad de catumaxomab como tratamiento de consolidación en pacientes con un cáncer epitelial de ovario en una segunda o tercera remisión completa
    A.4.1Sponsor's protocol code numberGEICO-1001
    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 SponsorGrupo Español de Investigación en Cáncer de Ovario - GEICO
    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 REMOVAB 10 microgramos concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS BIOTECH GMBH
    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 nameCatumaxomab
    D.3.2Product code Catumaxomab
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCATUMAXOMAB
    D.3.9.3Other descriptive nameCATUMAXOMAB
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number280
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticuerpo monoclonal quimerico anti EpCAM y anti CD3
    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
    eficacia y seguridad de catumaxomab como tratamiento de consolidación en pacientes con un cáncer epitelial de ovario en una segunda o tercera remisión completa
    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
    evaluar el efecto de la administración intraperitoneal de catumaxomab como tratamiento de consolidación en la supervivencia libre de progresión de los pacientes en una segunda o tercera respuesta completa clínica
    E.2.2Secondary objectives of the trial
    - determinar la seguridad del tratamiento seleccionado, el cumplimiento terapéutico y porcentaje de pacientes que reciben la 4ª dosis de catumaxomab según el esquema terapéutico (día 10), el intervalo libre de tratamiento, y la supervivencia global. Se recogerá de forma retrospectiva la supervivencia libre de progresión del tratamiento inicial de la enfermedad (SLP1) para compararlo con la obtenida tras el tratamiento de consolidación en segunda o tercera remisión completa

    - se explorará una posible asociación entre el nivel de de células inmunes medido en una muestra del cáncer de ovario, el intervalo entre la última dosis de quimioterapia y el inicio del catumaxomab, y el cumplimiento terapéutico con la eficacia del tratamiento de consolidación con catumaxomab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estudio biológico para la determinación de posibles factores predictivos de respuesta al tratamiento de consolidación con catumaxomab en pacientes con cáncer epitelial de ovario en una segunda o tercera remisión completa
    E.3Principal inclusion criteria
    - Consentimiento informado firmado y fechado por el paciente
    - Mujeres &#8805; 18 años
    - Estado funcional 0 o 1 por el Eastern Cooperative Oncology Group (ECOG)
    - Diagnóstico histológico de carcinoma epitelial de ovario, carcinoma primario peritoneal, o carcinoma del trompa de Falopio
    - El paciente deberá haber sido tratado mediante cirugía citorreductora combinado con una quimioterapia estándar basada en platino, y presentar un fallo a dicho tratamiento en forma de recurrencia. Se permitirá quimioterapia intravenosa, intraperitoneal o neoadjuvante, y también una intervención de intervalo. Deberemos disponer del intervalo entre el inicio del tratamiento (cirugía citorreductora, no diagnóstica, o quimioterapia neoadjuvante) y la recurrencia/ progresión de enfermedad según criterios GCIG.
    - Deberán estar en segunda o tercera remisión completa tras la administración de una quimioterapia de rescate, basada o no en platino, para la enfermedad recurrente. Se permitirá la realización de una cirugía de rescate en combinación con dicha quimioterapia
    - La respuesta clínica completa a la segunda o tercera línea de tratamiento se define como la ausencia de síntomas que sugieran la persistencia de cáncer, CA-125 normal (&#8804; 35 U/L), exploración física negativa y no evidencia de enfermedad por un TAC torácico/ abdominal/ pélvico. Anormalidades en ganglios linfáticos y/o partes blandas < 1 cm son frecuentes y no deben ser consideradas como evidencia de enfermedad.
    - Deberán haber recibido un mínimo de 4 ciclos de la quimioterapia que proporcione la segunda o tercera remisión completa
    - Los pacientes se deberán haber recuperado suficientemente del tratamiento previo con quimioterapia, basándose en los valores analíticos y el estado general descrito en los demás criterios de inclusión/ exclusión. De hecho podría suponer menos de 1 ó 2 semanas tras una pauta terapéutica estándar
    E.4Principal exclusion criteria
    - Infección aguda o crónica documentada
    - Participación actual, reciente (menos de 4 semanas) o planeada en un estudio con un fármaco experimental mientras esté participando en este estudio
    - Los pacientes no deben haber estado expuestos a las nitrosoureas o la mitomicina C o bevacizumab en las 6 semanas previas a la primera infusión de catumaxomab.
    - Tratamiento previo con anticuerpos monoclonales completamente murinos
    - Tratamiento con esteroides a largo plazo (&#8805; 7 días). Sólo se incluirán los pacientes tras la suspensión gradual del tratamiento esteroideo y la ausencia de éste durante un mínimo de 5 días.
    - Conocimiento o sospecha de hipersensibilidad a catumaxomab o anticuerpos similares
    - Función renal inadecuada: creatinina >1,5 x límite superior normal (LSN), y/o aclaramiento calculado de creatinina < 50 mL / minuto
    - Función hepática inadecuada: aspartato aminotransferasa (AST) y/o alanino aminotransferasa (ALT), >2,5 x LSN, y/o bilirrubina >1,5 x LSN
    - Plaquetas <80.000 células/mm3; recuento absoluto de neutrófilos (RAN) <1.000 células/mm3
    - Hemoglobina <8g/dL
    - Hipoalbuminemia: menor a 3 g/dL
    - Tiempo parcial de tromboplastina (TPT) > 2 x LSN
    - Pacientes con oclusión intestinal o suboclusión intestinal sintomática en los últimos 30 días
    - Signos o síntomas de enfermedad cardiovascular relevante, fallo cardíaco congestivo o arritmias cardiacas clínicamente relevantes o angor inestable o infarto de miocardio en los últimos 6 meses
    - El sujeto presenta un trastorno de cualquier tipo que compromete su capacidad de proporcionar el consentimiento informado escrito y/o cumplir con los procedimientos del estudio
    - Pacientes con cualquier otra enfermedad grave cuya participación en el estudio, implicara un riesgo excesivo, a criterio del investigador
    - Historial médico de otros cánceres en los últimos 5 años, excepto tumores con un riesgo insignificante de metástasis o muerte, como por ejemplo el carcinoma basocelular o escamoso cutáneo, el carcinoma in situ de mama, el carcinoma in situ de cervix, etc.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal del estudio es evaluar el efecto de la administración intraperitoneal de catumaxomab como tratamiento de consolidación en la supervivencia libre de progresión de los pacientes en una segunda o tercera respuesta completa clínica.
    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 Yes
    E.6.13.1Other scope of the trial description
    Estudio de Biomarcadores moleculares predictivos
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned18
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state39
    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 Decision2010-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
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