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    Summary
    EudraCT Number:2009-012380-34
    Sponsor's Protocol Code Number:CNTO328MCD2001
    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:2009-10-08
    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 number2009-012380-34
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo para valorar la eficacia y seguridad de CNTO 328 (anticuerpo monoclonal anti-IL-6) junto con la mejor terapia de soporte comparado con la mejor terapia de soporte, en sujetos con enfermedad de Castleman multicéntrica.
    A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
    Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman’s
    Disease
    A.4.1Sponsor's protocol code numberCNTO328MCD2001
    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 SponsorCentocor BV
    B.1.3.4CountryNetherlands
    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/3/07/508
    D.3 Description of the IMP
    D.3.1Product nameCNTO328
    D.3.2Product code CNTO328
    D.3.4Pharmaceutical form Powder 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.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeCNTO 328
    D.3.9.3Other descriptive nameChimeric murine human anti-IL-6 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 monoclonal antibody
    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 placeboPowder 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
    enfermedad de Castleman multicéntrica
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10050251
    E.1.2Term Castleman's disease
    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 de este estudio es demostrar que CNTO 328 en combinación con el MTS es superior al MTS en cuanto a la respuesta objetiva (respuesta completa [RC] + respuesta parcial [RP]) en los sujetos con enfermedad de Castleman multicéntrica (ECM).
    The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superior
    to BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjects
    with multicentric Castleman?s disease (MCD).
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son:
    • Demostrar otros criterios de eficacia (duración de la respuesta tumoral; tiempo transcurrido hasta el fracaso del tratamiento; variación en los niveles de hemoglobina; capacidad de suspender los corticoides; y mejora de la fatiga, la función física y otros síntomas relacionados con la enfermedad)
    • Estudiar la seguridad de la administración prolongada
    • Determinar la farmacocinética de CNTO 328 en sujetos con ECM
    • Determinar un valor basal de hepcidina predictivo de un aumento &#8805; 2 g/dl de la hemoglobina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ECM sintomática y medible confirmada mediante biopsia. La enfermedad sintomática se define clínicamente por la presencia de síntomas o anomalías analíticas notables con un grado &#8805; 1 según los CTC-AA del NCI que sean atribuibles a la enfermedad (véase el anexo 1) y en las que está indicado el tratamiento. Los sujetos deberán tener una enfermedad medible, que puede estar limitada a lesiones cutáneas. Las elevaciones de proteínas de fase aguda (PCR, fibrinógeno) y el aumento de la VSG en ausencia de otros síntomas no cumplen los requisitos de enfermedad sintomática.
    2. Edad &#8805; 18 años.
    3. Los valores analíticos previos al tratamiento cumplen los criterios siguientes dentro de las 4 semanas previas al tratamiento:
    CNTO 328: Protocolo clínico CNTO328MCD2001
    Aprobado el 17 de julio de 2009 37
    a. Recuento absoluto de neutrófilos (RAN) &#8805; 1,0 x 109/l
    b. Plaquetas &#8805; 75 x 109/l
    c. ALT; fosfatasa alcalina no fraccionada dentro de 2,5 veces el límite superior de normalidad (LSN); si está por encima de 2,5 veces el LSN, los sujetos serán elegibles si la fracción hepática de la fosfatasa alcalina está dentro de 2,5 veces el LSN; bilirrubina total dentro de 2,5 veces el LSN
    d. Creatinina sérica &#8804; 3,0 mg/dl
    4. Estado funcional ECOG de 0, 1 ó 2 (véase el anexo 2).
    5. Dosis de corticoides que no superen 1 mg/kg/día de prednisona (o equivalente; véase el anexo 3) y que hayan permanecido estables o hayan disminuido durante las 4 semanas previas a la inclusión.
    6. Las mujeres en edad fértil deberán utilizar métodos anticonceptivos adecuados. Se requiere una prueba de embarazo negativa (gonadotropina coriónica humana beta [&#946;-HCG] en suero u orina) en la selección (aplicable a las mujeres en edad fértil).
    7. Los sujetos (o sus representantes legales) deberán haber firmado un documento de consentimiento informado que indique que entienden el objetivo del estudio y los procedimientos que exige y que están dispuestos a participar en él. El consentimiento informado deberá obtenerse antes de realizar ninguno de los procedimientos específicos del estudio.
    E.4Principal exclusion criteria
    1. Seropositivo para el VIH o el VHH-8.
    2. Linfoma previo.
    3. Neoplasias malignas, excepto carcinoma de piel basocelular o de células escamosas debidamente tratado, carcinoma in situ de cuello uterino u otro cáncer distinto de un linfoma del que el sujeto haya permanecido libre de enfermedad durante un mínimo de 3 años.
    4. Proceso médico o enfermedad concurrente (p. ej., enfermedad autoinmunitaria, infección sistémica activa, diabetes no controlada o enfermedad pulmonar infiltrativa difusa aguda) que probablemente interfiera en los procedimientos o resultados del estudio o que, en opinión del investigador, pueda suponer un riesgo para la participación en este estudio
    5. Empleo de tratamientos prohibidos: otros tratamientos antitumorales concomitantes contra la enfermedad de Castleman (p. ej., anticuerpos anti-CD20, tratamientos
    CNTO 328: Protocolo clínico CNTO328MCD2001
    Aprobado el 17 de julio de 2009 38
    dirigidos contra la IL-6 o su receptor y quimioterapia), tratamientos biológicos, como anticuerpos contra el factor de necrosis tumoral &#945; (TNF&#945;), inmunosupresores (excepto dosis estables de corticoides) y fármacos estimuladores de la eritropoyetina (FEE)
    6. Que haya recibido un fármaco en investigación (incluidas vacunas) o algún tratamiento sistémico contra la enfermedad de Castleman en las 4 semanas (o, en el caso de rituximab, en las 8 semanas) previas al comienzo previsto del tratamiento.
    7. Cirugía mayor en las 4 semanas anteriores al tratamiento.
    8. Antecedentes de cardiopatía no controlada, como angina de pecho inestable, insuficiencia cardíaca congestiva, infarto de miocardio en los 12 meses precedentes, inestabilidad hemodinámica o fracción de eyección del ventrículo izquierdo (FEVI) < 30 % o anomalías del ritmo o la conducción clínicamente significativos.
    9. Infecciones clínicamente significativas, como infección conocida por el virus de la hepatitis C o positivo para el antígeno de superficie del virus de la hepatitis B (HBsAg).
    10. Antecedentes de trasplante alogénico (excepto trasplantes corneales).
    11. Alergias, hipersensibilidad o intolerancia conocidas a anticuerpos monoclonales, a proteínas murinas, quiméricas o humanas o a sus excipientes.
    12. Embarazo o lactancia.
    13. Vacunación con vacunas de microorganismos vivos o atenuados en las 4 semanas previas a la primera administración del fármaco del estudio.
    14. Penfigo paraneoplásico o bronquiolitis obliterante.
    15. Cualquier trastorno que, en opinión del investigador, comprometería el bienestar del sujeto o el estudio o que impediría que el sujeto cumpliera o realizara los requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de la eficacia será la respuesta tumoral objetiva (RC + RP) modificada para permitir la evaluación de las lesiones cutáneas medibles, medidas según los criterios de Cheson (Cheson y cols., 2007; no se tendrán en cuenta los datos de PET, en caso de haberse obtenido).
    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 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) 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 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) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    La finalización del estudio se define en un año después que el último paciente empieza el tratamiento del estudio.
    The end of study is defined as one year after the last subject starts study treatment.
    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 months9
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days25
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    El representante legal del sujeto debe firmar el documento de consentimiento informado indicando que entienden el propósito y procedimientos requeridos del estudio y están dispuestos a participar en el estudio.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 75
    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 ensayo finalizará 1 año después del último paciente aleatorizado en el estudio. En ese momento, cualquier paciente que se esté beneficiando del tratamiento, podrá pasar a un protocolo de extensión del ensayo. De lo contrario, no hay más planes de tratamiento o cuidados que lo estandar para ECM.
    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 Decision2009-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-24
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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