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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41230   clinical trials with a EudraCT protocol, of which   6756   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2006-001671-38
    Sponsor's Protocol Code Number:C0328T07
    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:2010-03-11
    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 number2006-001671-38
    A.3Full title of the trial
    Estudio Fase 2, abierto, multicéntrico de CNTO 328 (Anticuerpo Monoclonal Anti-IL-6) en combinación con mitoxantrona versus mitoxantrona en sujetos con Cáncer de Próstata Metastásico Hormono-Resistente (CPHR)
    A.4.1Sponsor's protocol code numberC0328T07
    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 B.V.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CNTO 328
    D.3.4Pharmaceutical form 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 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 typeMonoclonal Antibody
    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 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 nameMitoxantrone
    D.3.2Product code 1276 IS 220 F 12
    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.3.8INN - Proposed INNmitoxantrone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 typeAnthracycline
    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
    Cáncer de Próstata Metastático Hormono-Resistente
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo principal: El objetivo principal de la parte 1 de este protocolo es evaluar la seguridad de CNTO 328 administrado como infusión IV en combinación con mitoxantrona en sujetos con CPHR metastásico que sólo han recibido un régimen previo de quimioterapia basado en docetaxel.El objetivo principal de la parte 2 es comparar CNTO 328 combinado con mitoxantrona frente a mitoxantrona sola en cuanto a la SSP de sujetos con CPHR metastásico que sólo han recibido un régimen previo de quimioterapia basado en docetaxel.
    E.2.2Secondary objectives of the trial
    Objetivos secundarios: Los objetivos secundarios de la parte 2 son evaluar y comparar los criterios de valoración de la seguridad y otros criterios de valoración de la eficacia de CNTO 328 en combinación con mitoxantrona frente a mitoxantrona en sujetos con CPHR metastásico que sólo han recibido un régimen previo de quimioterapia basado en docetaxel. Además, se evaluarán las respuestas de los biomarcadores farmacodinámicos y de los resultados de salud.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Varones ≥ 18 años
    2.Consentimiento informado firmado obtenido antes de cualquier procedimiento de selección específico del estudio
    3.Adenocarcinoma de próstata confirmado histológica o citológicamente
    4.Enfermedad metastásica documentada radiológicamente
    5.Al menos 6 semanas de tratamiento con régimen previo de quimioterapia basado en docetaxel por CPHR metastásico
    6.Progresión de la enfermedad durante el tratamiento previo con docetaxel o en los 6 meses posteriores a su interrupción, basada en uno de los siguientes parámetros:
    a.Progresión del nivel sérico de PSA, definida como el incremento de al menos 2 valores consecutivos de PSA en suero obtenidos con un intervalo mínimo de 1 semana
    b.Progresión radiológica de la enfermedad: si la progresión de la enfermedad sólo se demuestra con una gammagrafía, esta se definirá por la presencia de dos o más lesiones óseas nuevas
    7.Orquiectomía o testosterona ≤ 50 ng/dl por castración farmacológica/química
    8.Período mínimo de 4 semanas desde el tratamiento antineoplásico previo
    9.ECOG ≤ 2
    10.Valores de laboratorio de selección para ser incluido en el estudio:
    a.RL ≥ 3,0 x 109/l y recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 109/l
    b.Hemoglobina ≥ 9,0 g/dl
    c.Recuento de plaquetas ≥ 100 x 109/l
    d.AST y ALT ≤ 2,5 x LSN
    e.Bilirrubina ≤ 1,5 x LSN
    f.Creatinina ≤ 1,5 x LSN
    11.FEVI ≥ 50%
    E.4Principal exclusion criteria
    Los sujetos que cumplan cualquiera de los criterios siguientes no podrán ser admitidos en el estudio:
    1.Cáncer de próstata que no expresa PSA o que el nivel de PSA es < 5,0 ng/ml en el periodo de selección.
    2.Metástasis conocidas en el SNC.
    3.Tratamiento con un agente/fármaco experimental en los 30 días o en 5 semividas previas, aquello que sea mayor.
    4.Tratamiento con más de una línea de quimioterapia sistémica para el CPHR metastásico.
    5.Tratamiento previo con mitoxantrona para el CPHR.
    6.Neoplasia maligna previa (distinta del cáncer de próstata) salvo cáncer de vejiga superficial correctamente tratado, carcinoma de células basales o de células escamosas de la piel u otro cáncer sin progresión durante ≥ 3 años.
    7.Seropositividad conocida al VIH o infección conocida por el virus de la hepatitis B o C.
    8.Cirugía mayor programada durante el estudio.
    9.Tratamiento con cualquier AM en 60 días posteriores a la primera dosis del agente del estudio.
    10.Enfermedad concomitante grave o cardiopatía significativa caracterizada por cardiopatía isquémica importante, arritmias significativas o insuficiencia cardíaca congestiva (clase ≥ II de la New York Heart Association [NYHA]; Apéndice B) o infarto de miocardio en los últimos 6 meses.
    11.Cualquier trastorno médico, infección grave o presencia de alteraciones analíticas clínicamente importantes no controladas que supongan un riesgo inaceptable para el sujeto debido a su participación en el estudio o que interfieran con la capacidad para interpretar los datos del estudio.
    12.Tratamiento con bisfosfonatos iniciado < 6 semanas antes de la primera administración de CNTO 328.
    13. Anemia que requiera transfusión
    14. Administración de vacunas vivas atenuadas en las 4 semanas anteriores a la primera administración de CNTO 328. La vacuna inactivada inyectable para el virus de la gripe está permitida.
    15. Alergias conocidas o reacciones clínicamente significativas a proteínas murinas, quiméricas o humanas.
    16. Historial médico que sugiera una médula ósea sospechosa de cumplir con los criterios de inclusión del estudio (p. ej, neutropenia febril recurrente, infección neutropénica, múltiples retrasos de dosis durante el tratamiento previo con docetaxel, el uso necesario
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de la parte 1 es la seguridad y el de la parte 2 es la SSP (Supervivencia sin progresión)
    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 Yes
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Ver protocolo
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 No
    F.2.2Male Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 134
    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)
    No diferente del tratamiento normal esperado
    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 Decision2007-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-20
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