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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2010-021425-13
    Sponsor's Protocol Code Number:212082PCR3001
    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:2011-02-03
    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 number2010-021425-13
    A.3Full title of the trial
    Estudio abierto de acetato de abiraterona en pacientes con cáncer de próstata metastático resistente a la castración que han progresado después de la quimioterapia con taxanos
    A.4.1Sponsor's protocol code number212082PCR3001
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 nameAbiraterone acetate
    D.3.2Product code CB7630
    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 INNAbiraterone acetate
    D.3.9.2Current sponsor codeCB7630
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer de próstata metastásico resistente a castración (CPRC)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo de este estudio es obtener datos de seguridad adicionales durante el tratamiento con acetato de abiraterona y prednisona en pacientes con cáncer de próstata metastático resistente a la castración (CPRC) que hayan fracasado a 1 ó 2 pautas de quimioterapia, 1 de ellas con un taxano como Docetaxel que residan en áreas en las que el acetato de abiraterona todavía no está disponible a través de los profesionales sanitarios locales y que no sean candidatos para participar en algún estudio clínico sobre acetato de abiraterona que esté actualmente en curso.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1-Los pacientes deberán haber firmado un documento de consentimiento informado que indique que entienden el objetivo del estudio y los procedimientos que éste exige, y que están dispuestos a participar en él.
    2-Se ha obtenido la autorización por escrito para el Uso y Divulgación de Información de Salud y de Investigación (sólo para centros estadounidenses) o el Consentimiento para la Protección de Datos Personales (sólo para centros europeos).
    3-Se pedirá a pacientes de los centros que participen en la obtención de datos sobre CdV/URM que firmen el consentimiento informado por escrito para la recogida de estos datos personales.
    4-Edad 18 años y sexo masculino.
    5-Adenocarcinoma de próstata confirmado por medios histológicos o citológicos, sin diferenciación neuroendocrina ni histología de carcinoma de células pequeñas.
    6-Haber recibido al menos una pero no más de dos pautas de quimioterapia citotóxica para CPRC metastásico. Al menos una de las pautas debía contener un taxano como docetaxel. Si se ha utilizado una pauta de quimioterapia con un taxano en más de una ocasión, se considerará como una sola pauta.
    7-Progresión del cáncer de próstata evaluado por el investigador mediante uno de los siguientes métodos:
    -Progresión del PSA según los criterios del Prostate Cancer Working Group 2 (PCWG2).
    -Progresión radiológica en tejidos blandos según los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST), o en las gammagrafías óseas, con o sin progresión del PSA.
    8-Privación de andrógenos en curso, con concentración sérica de testosterona < 50 ng/dl (< 2,0 nM).
    9-Estado funcional 2 según el Eastern Cooperative Oncology Group (ECOG).
    10-Hemoglobina 9,0 g/dl con independencia de transfusiones.
    11-Recuento plaquetario 100.000/µl.
    12-Albúmina sérica 3,0 g/dl.
    13-Creatinina sérica < 1,5 x límite superior de la normalidad (LSN) o aclaramiento de creatinina calculado 60 ml/min.
    14-Potasio sérico 3,5 mmol/l.
    15-Capaz de tragar la medicación del estudio en comprimidos.
    E.4Principal exclusion criteria
    1-Elegible para otro estudio de acetato de abiraterona que esté abierto a reclutamiento. El monitor médico deberá autorizar la participación en este estudio si el paciente es elegible para otro estudio abierto sobre acetato de abiraterona.
    2-Haber recibido tratamiento con acetato de abiraterona en el pasado o haber sido reclutado en los estudios COU-AA-301 o COU-AA-302.
    3-Enfermedad no maligna grave o no controlada concurrente, incluida la infección activa y no controlada.
    4-Cualquiera de las siguientes anomalías en las pruebas funcionales hepáticas:
    -Bilirrubina sérica 1,5 x LSN (excepto pacientes con enfermedad de Gilbert documentada, en quienes el límite superior de la bilirrubina sérica es de 3 mg/dl).
    -Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) 2,5 x LSN.
    5-Hipertensión no controlada (presión arterial sistólica 160 mm Hg o presión arterial diastólica 95 mm Hg); podrán participar pacientes que presenten antecedentes de hipertensión si la presión arterial se controla con tratamiento antihipertensivo.
    6-Hepatitis viral activa o sintomática, o hepatopatía crónica.
    7-Antecedentes de disfunción hipofisaria o suprarrenal.
    8-Cardiopatía clínicamente significativa, como infarto de miocardio, o episodios trombóticos arteriales en los 6 meses anteriores, angina grave o inestable, o cardiopatía de clase III o IV de la New York Heart Association (NYHA), o fracción de eyección ventricular izquierda (FEVI) de < 50% en el momento basal.
    9-Metástasis cerebrales.
    10-Antecedentes de trastornos digestivos (enfermedades o cirugía extensa) que pueden interferir en la absorción del fármaco del estudio.
    11-Toda toxicidad aguda por quimioterapia o radioterapia previa que no se hayan resuelto a grado 1 de los NCI-CTCAE (versión 4.0). Se permiten la alopecia inducida por la quimioterapia y la neuropatía periférica de grado 2.3
    12-Tratamiento sistémico previo con un fármaco azólico (por ejemplo, fluconazol, itraconazol, ketoconazol) en las 4 semanas previas al día 1 del ciclo 1.
    13-Reclutamiento actual en un estudio con fármacos o dispositivos en investigación, o participación en un estudio de ese tipo en los 30 días previos al día 1.
    14-Trastorno o situación que, en opinión del investigador, pueda suponer un riesgo importante para los pacientes, confundir los resultados del estudio o interferir de forma significativa en la participación en el estudio.
    15-Pacientes que tengan parejas en edad fértil que no estén dispuestas a utilizar un método anticonceptivo con una protección de barrera adecuada que el investigador principal y el promotor consideren aceptable durante el estudio y hasta 13 semanas después de la última administración del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La principal variable a medir de este estudio son los acontecimientos adversos que ocurran durante el tratamiento y hasta 30 días después de la administración del fármaco de estudio.
    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 No
    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
    Facilitar el acceso precoz a acetato de abiraterona
    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 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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 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
    El estudio se considera finalizado con la última evaluación del último paciente participante en el estudio (es decir, cuando se obtenga la última evaluación antes de la autorización de comercialización en la región en que el paciente recibe tratamiento o hasta que acetato de abiraterona esté disponible por prescripción médica o por otro procedimiento regulado en el país donde el paciente es tratado).
    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 months0
    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 months0
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 960
    F.4.2.2In the whole clinical trial 5000
    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 Decision2011-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-19
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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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