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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2009-014076-22
    Sponsor's Protocol Code Number:IP-CAT-AC-04
    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:2009-12-17
    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 number2009-014076-22
    A.3Full title of the trial
    Phase II open label study to evaluate the safety of a second i.p. infusion cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study (IP-CAT-AC-03). Estudio abierto de fase II para evaluar la seguridad de un segundo ciclo de infusión i.p. de catumaxomab en pacientes con ascitis maligna causada por un carcinoma que precisan la primera punción terapéutica tras el tratamiento del estudio CASIMAS (IP-CAT-AC-03).
    A.3.2Name or abbreviated title of the trial where available
    SECIMAS
    A.4.1Sponsor's protocol code numberIP-CAT-AC-04
    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 SponsorFresenius Biotech GmbH
    B.1.3.4CountryGermany
    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 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this 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 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) 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 typeAntibody developed by hybridoma method
    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 REMOVAB 50 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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this 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 typeequal
    D.3.10.3Concentration number50
    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 typeAntibody developed by hybridoma method
    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
    malignant ascites / ascitis maligna
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10025538
    E.1.2Term Malignant ascites
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio consiste en evaluar la seguridad de un segundo ciclo de infusión i.p. durante tres horas, consistente en cuatro administraciones de dosis ascendentes de catumaxomab, tras haber completado las cuatro infusiones i.p. del estudio CASIMAS, en pacientes con ascitis maligna causada por un carcinoma que precisan la primera punción terapéutica.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del estudio consisten en determinar otros parámetros de seguridad, la eficacia, calidad de vida, el motivo de los síntomas relacionados con la ascitis, la manipulación del catéter, así como la farmacocinética y farmacodinámica de un segundo ciclo de infusión i.p. con catumaxomab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes serán incluidos en este estudio solamente si cumplen todos los criterios siguientes:
    -Pacientes capaces de entender los fines y riesgos del estudio, que deseen y puedan participar en el estudio, y que hayan dado su consentimiento informado por escrito y fechado para participar en el estudio.
    -Pacientes que hayan completado las cuatro infusiones de catumaxomab del estudio CASIMAS.
    -Edad: >/= 18 años
    -Índice de Karnofsky >/= 60%
    -Pacientes con ascitis maligna que precisan la primera paracentesis terapéutica de las ascitis, después de haber transcurrido al menos 60 días desde la última infusión de catumaxomab del estudio CASIMAS.
    -Pacientes para los que ya no existe o ya no es viable un tratamiento estándar
    -Índice de masa corporal (BMI) entre 17 y 40 kg/m2; antes del cálculo del BMI restar al «peso corporal» el peso estimado del volumen de la ascitis actual (el valor de exploración es suficiente).
    E.4Principal exclusion criteria
    Los pacientes no se incluirán en este estudio si cumplen alguno de los criterios siguientes:
    -Infección aguda o crónica documentada
    -Tratamiento concomitante con productos de investigación, que no sea catumaxomab, para la terapia contra el cáncer, quimioterapia o radioterapia.
    -En casos de exposición previa a un producto de investigación, que no sea el catumaxomab, para la terapia contra el cáncer, quimioterapia o radioterapia (salvo por el tratamiento de radiación local para las metástasis en la médula ósea), los pacientes deberán ser excluidos cuando no estén suficientemente recuperados del tratamiento anterior (toxicidad presente), basándose en los valores de laboratorio adecuados y en el estado general según otros criterios de inclusión y exclusión (por ejemplo, exclusión si ha transcurrido menos de una o dos semanas desde un régimen de tratamiento anterior semanal o quincenal). Los pacientes no deberán haber estado expuestos a nitrosoureas ni a mitomicina C durante las seis semanas previas a la primera infusión de catumaxomab.
    -Tratamiento previo con anticuerpos monoclonales murinos puros distintos al catumaxomab
    -Hipersensibilidad conocida o sospechada a catumaxomab o anticuerpos similares
    -Función respiratoria inadecuada, incluyendo efusión pleural sintomática, metástasis distante salvo la carcinomatosis peritoneal que provoque una dificultad respiratoria importante o muy grave y disnea en reposo, debido a complicaciones de un cáncer avanzado o de otra enfermedad, o pacientes que precisen apoyo ventilatorio.
    -Función renal inadecuada (creatinina > 1,5 ? límite máximo normal [ULN] o GFR (tasa de filtración glomerular) < 75% del límite mínimo normal [LLN])
    -Función hepática inadecuada (aspartato aminotransferasa [AST] > 5 x ULN; alanina aminotransferasa [ALT] > 5 x ULN; bilirrubina > 1,5 x ULN)
    -Plaquetas < 80 000 células/mm3; recuento absoluto de neutrófilos (ANC) < 1 500 células/mm3
    -Albúmina inferior a 3 g/dL o proteína total inferior a 6 g/dL
    -Tiempo parcial de tromboplastina (PTT) > 2 x ULN
    -Hemoglobina < 8 g/dL
    -Pacientes que precisan alimentación parenteral total
    -Pacientes con íleo o con subíleo sintomático en los últimos 30 días
    -Signos o síntomas de enfermedad cardiovascular, fallo cardíaco congestivo o arritmias cardíacas importantes (Asociación Cardíaca de Nueva York [NYHA] clase > II)
    -Metástasis hepática con un volumen > 70% de tejido hepático metastasiado
    -Obstrucción conocida de la vena portal
    -Metástasis cerebral conocida
    -Falta de capacidad o voluntad para cumplir plenamente el protocolo
    -Pacientes con enfermedades médicas o psicológicas, que, en opinión del investigador, podrían impedir el cumplimiento de los requisitos del estudio
    -Mujeres embarazadas, en período de lactancia y hombres o mujeres en edad fértil que no deseen utilizar métodos anticonceptivos fiables (métodos hormonales de control de la natalidad, incluyendo anticonceptivos orales, implantes anticonceptivos o métodos de barrera, tales como el preservativo masculino o femenino, el diafragma, el tapón cervical más un espermicida). Se deberá utilizar un método anticonceptivo efectivo durante todo el estudio y hasta seis semanas después de la conclusión del mismo
    -Pacientes con otra enfermedad grave que, en opinión del investigador, para los que la participación en el estudio podría suponer un riesgo innecesario
    -Pacientes enviados a una institución por las autoridades judiciales
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal es la proporción de pacientes a la que se le puede administrar un segundo ciclo de al menos tres infusiones i.p. de catumaxomab
    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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    in the protocol
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    standard treatment
    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 Decision2010-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-02
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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