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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2010-018661-35
    Sponsor's Protocol Code Number:C21004
    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:2010-09-24
    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 number2010-018661-35
    A.3Full title of the trial
    Ensayo fase 3, aleatorizado, doble ciego, multicéntrico para comparar Orteronel (TAK 700) más prednisona frente a placebo más prednisona en pacientes con cáncer de próstata metastásico resistente a la castración no tratados previamente con quimioterapia.

    A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
    A.4.1Sponsor's protocol code numberC21004
    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 SponsorMillennium Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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.3.1Product nameDCI propuesta - Orteronel
    D.3.2Product code TAK-700
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDCI propuesta - Orteronel
    D.3.9.1CAS number 566939-85-3
    D.3.9.2Current sponsor codeTAK-700
    D.3.9.3Other descriptive name6-[(7S)-7-hidroxi-6,7-dihidro-5H-pirrolo[1,2-c]imidazol-7-il]-N-metil-2- naftamida
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    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 Decortin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDecortin
    D.3.2Product code Prednisona
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONA
    D.3.9.1CAS number 53-03-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cáncer de próstata metastásico resistente a la castración no tratado previamente con quimioterapia.

    Chemotherapy-naive Metastatic Castration-resisitant Prostate Cancer.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si orteronel más prednisona mejora la supervivencia sin progresión radiográfica (SSPr).
    Determinar si orteronel más prednisona mejora la supervivencia global (SG).
    E.2.2Secondary objectives of the trial
    • Determinar si orteronel más prednisona mejora la respuesta del antígeno prostático específico (PSA) del 50% a las 12 semanas.
    • Evaluar las variaciones de los recuentos de células tumorales circulantes (CTC).
    • Evaluar si orteronel mejora el tiempo hasta la progresión del dolor.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Dos subestudios, de biomarcadores óseos y del perfil de biomarcador de CTC se realizarán en los centros escogidos, no obstante España no será escogida para esta parte del estudio. Se proporciona información sobre estos subestudios en el protocolo C21004, de fecha 21 de julio de 2010.
    E.3Principal inclusion criteria
    Todos los pacientes deberán cumplir la totalidad de los criterios siguientes para ser incluidos en el estudio:
    • Consentimiento voluntario por escrito
    • Varones de 18 años de edad en adelante
    • Adenocarcinoma de próstata confirmado por histología o por citología
    • Enfermedad metastásica confirmada por TC/RM
    • Enfermedad progressiva
    • Castración quirúrgica previa o el uso concurrente de un fármaco para la castración médica
    • Ausencia de dolor o presencia de dolor que no precisa el uso de ningún opiáceo ni narcótico en las 2 semanas previas a la aleatorización
    • Estado funcional de Cooperative Oncology Group (ECOG) de 0 ó 1.
    • Aunque estén esterilizados quirúrgicamente, los pacientes deben Utilizar un método anticonceptivo de barrera eficaz hasta un mes después de la última dósis del fármaco del estudio, O Abstenerse de mantener relaciones heterosexuales.
    • Cumplir los valores de laboratorio de selección como se especifica en el protocolo.
    • Situación médica estable.
    E.4Principal exclusion criteria
    No podrán participar en el estudio los pacientes que cumplan cualquiera de los siguientes criterios de exclusión:
    Hipersensibilidad conocida a orteronel, prednisona o al análogo de la hormona que libera gonadotropina (GnRH).
    Tratamiento previo con orteronel, aminoglutetimida, ketoconazol o abiraterona
    Tratamiento con un antiandrógeno en las 6 semanas anteriores para bicalutamida y en las 4 semanas anteriores para los demás antes de la primara dosis del fármaco del estudio.
    Uso diario continuo de prednisona oral o dexametasona oral durante más de 14 días en los 3 meses previos al estudio.
    Quimioterapia previa para el cancer de prostata.
    Exposición a tratamiento con isótopos radiactivos en las 4 semanas previas a la administración de la primera dosis del fármaco del estudio; exposición a radiación externa desde 2 semanas antes del inicio de la selección hasta la administración de la primera dosis del fármaco del estudio.
    Metástasis documentadas en el sistema nervioso central.
    Tratamiento con cualquier fármaco en investigación en los 30 días anteriores a la administración de la primera dosis del fármaco del estudio.
    Presencia en la actualidad de compresión de la médula espinal, hidronefrosis bilateral u obstrucción del flujo de salida del cuello de la vejiga.
    Diagnóstico o tratamiento para otra neoplasia maligna en los 2 años previos a la administración de la primera dosis del fármaco del estudio, salvo en el caso de cáncer de piel distinto del melanoma o cáncer in situ completamente extirpado.
    Enfermedad cardiovascular no controlada como se especifica en el protocolo del estudio.
    Antecedente conocido de infección por el virus de la inmunodeficiencia humana (VIH), de hepatitis B, o de hepatitis C.
    No querer o no ser capaz de cumplir el protocolo.
    Enfermedad que ponga en peligro la vida no relacionada con el cáncer.
    Náuseas, vómitos o diarrea no controlados
    Enfermedad o procedimiento gastrointestinal conocidos que puedan interferir con la absorción oral o la tolerabilidad del orteronel
    E.5 End points
    E.5.1Primary end point(s)
    Determinar si orteronel más prednisona mejora la supervivencia sin progresión radiográfica (SSPr).
    Determinar si orteronel más prednisona mejora la supervivencia global (SG).
    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 No
    E.6.10Pharmacogenetic Yes
    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 EEA198
    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
    Se hará un seguimiento de todos los pacientes para la supervivencia (seguimiento a largo plazo) tras la interrupción del tratamiento/parte de seguiemiento a corto plazo del estudio. El seguimiento a largo plazo continuará hasta la muerte o la finalización del estudio por parte del promotor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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 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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 798
    F.4.2.2In the whole clinical trial 1454
    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 Decision2011-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-07
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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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