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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2012-005665-12
    Sponsor's Protocol Code Number:MDV3100-14
    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:2013-08-08
    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 number2012-005665-12
    A.3Full title of the trial
    A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer
    Estudio multinacional, de fase III, aleatorizado, con doble enmascaramiento y controlado con placebo, de la eficacia y la seguridad de la enzalutamida en los pacientes con cáncer de próstata no metastatizante, resistente a la castración
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multinational study to evaluate the safety and effectiveness of enzalutamide in patients whose prostate cancer has not metastasized
    Estudio multinacional para evualuar la seguridad y efectividad de la enzalutamida en pacientes cuyo cáncer de próstata no tiene metástasis.
    A.4.1Sponsor's protocol code numberMDV3100-14
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedivation, 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 supportMedivation, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAstellas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedivation, Inc.
    B.5.2Functional name of contact pointMedical Officer
    B.5.3 Address:
    B.5.3.1Street Address525 Market Street, 36th Floor
    B.5.3.2Town/ citySan Francisco, CA
    B.5.3.3Post code94105
    B.5.3.4CountryUnited States
    B.5.4Telephone number14155433470
    B.5.5Fax number14155433411
    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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameXtandi (enzalutamide)
    D.3.2Product code MDV3100
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.2Current sponsor codeMDV3100
    D.3.9.3Other descriptive nameXtandi
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboCapsule, soft
    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
    Patients With Nonmetastatic Castration Resistant Prostate Cancer
    pacientes con cáncer de próstata no metastatizante resistente a la castración?
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cáncer de próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    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
    To determine the efficacy of enzalutamide compared with placebo as assessed by metastasis free survival (MFS).
    Determinar la eficacia de la enzalutamida en comparación con un placebo evaluada en función de la supervivencia sin metástasis (MFS, por sus siglas en inglés)
    E.2.2Secondary objectives of the trial
    ? To evaluate the benefit of enzalutamide compared with placebo as measured by the following:
    -Overall survival;
    -Time to pain progression;
    -Time to opiate use for prostate cancer pain;
    -Time to pain progression or opiate use for prostate cancer pain;
    -Time to first use of cytotoxic chemotherapy;
    -Time to first use of new antineoplastic therapy;
    -Time to prostate specific antigen (PSA) progression;
    -PSA response rates;
    -Time to functional status deterioration as assessed by the Functional Assessment of Cancer Therapy Prostate (FACT P) global score;
    -Quality of life as assessed by the European Quality of Life 5 Dimensions 5 Levels (EQ 5D 5L) health questionnaire and Quality of Life Questionnaire Prostate 25 (QLQ PR25) module.
    AND
    ?To evaluate safety.
    . Evaluar las ventajas de la enzalutamida en comparación con un placebo, medidos según los siguientes aspectos:
    - La supervivencia global
    - El tiempo hasta la progresión del dolor
    - el tiempo hasta el uso de opiáceos para el dolor de cáncer de próstrata;
    - El tiempo hasta el uso inicial de la quimioterapia citotóxica;
    - el tiempo hasta el uso inicial del nuevo tratamiento antineoplásico;
    - el tiempo hasta la progresión del antígeno prostático específico (PSA);
    - La tasa de respuesta del PSA;
    - el tiempo hasta el deterioro dle estado funcional, evaluado según la puntuación global de la Evaluación Funcional de la terapia Oncológica-Prostata(FACT-P)
    - La calidad de vida, evaluada según el cuestionario de salud de calidad de vida europea, 5 dimensiones y 5 niveles (EQ-5D-5L) y el módulo Cuestionario sobre calidad de vida-Prostata 25 (QLQ-PR25)
    Y
    . Evaluar la seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age 18 years or older and willing and able to provide informed consent;
    2.Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
    3.Ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
    4.Testosterone ? 50 ng/dL (? 1.73 nmol/L) at screening;
    5.For patients receiving bisphosphonates or denosumab, dose must be stable for at least 4 weeks before randomization;
    6.Progressive disease on androgen deprivation therapy at enrollment defined as a minimum of 3 rising PSA values (PSA1 < PSA2 < PSA3) assessed by a local laboratory (local PSA) with an interval of ? 1 week between each determination.
    1.Tener 18 años o más y estar dispuestos a prestar su consentimiento informado, además de disponer de capacidad para hacerlo;
    2.Padecer adenocarcinoma de próstata confirmado mediante histología o citología sin diferenciación neuroendocrina, células en sello, ni características microcíticas;
    3.estar sometidos a tratamiento de deprivación andrógena en curso con un agonista/antagonista de la GnRH u orquiectomía bilateral anterior (castración quirúrgica o médica)
    4.Testosterona ? 50 ng/dL (? 1.73 nmol/L) durante la selección
    5. En el caso de los pacientes que reciban bisfosfonatos o denosumab, la dosis debe ser estable durante al menos 4 semanas antes de la aletorización
    6.presentar una enfermedad progresiva con tratamiento de deprivación andrógena durante la inscripción, definida como un mínimo de tres valores del PSA en aumento (PSA1 < PSA2 < PSA3), con una evaluación por un laboratorio local (PSA local), con un intervalo de ? 1 semana entre cada determinación;
    E.4Principal exclusion criteria
    1.Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
    2.Treatment with hormonal therapy (eg, androgen receptor inhibitors, estrogens, 5 alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization;
    3.Use of an investigational agent within 4 weeks of randomization;
    4.Known or suspected brain metastasis or active leptomeningeal disease;
    5.History of another invasive cancer within 3 years of randomization, with the exception of fully treated cancers with a remote probability of recurrence in the opinion of both the medical monitor and investigator.
    1.quimioterapia citotóxica, aminoglutetimida, ketoconazol, acetato de abiraterona o enzalutamida anterior, durante el tratamiento del cáncer de próstata, o participación en un ensayo clínico de una medicamento en fase de investigación que inhiba el receptor de andrógenos o la síntesis de andrógenos (a menos que el tratamiento fuera un placebo)
    2.hormonoterapia (p. ej., inhibidores de los receptores de andrógenos, estrógenos, inhibidores de la 5-? reductasa) o tratamiento biológico para el cáncer de próstata (aparte de los medicamentos aprobados que actúan en las zonas óseas y del tratamiento con agonistas/antagonistas de la GnRH) en el plazo de 4 semanas antes de la aleatorización;
    3. el uso de un medicamento en fase de investigación en las 4 semanas anteriores a la aleatorización;
    4. metástasis encefálica conocida o sospechada, o enfermedad leptomeníngea activa;
    5. antecedentes de otro cáncer invasivo en los tres años anteriores a la aleatorización, con excepción del cáncer tratado completamente, con una probabilidad remota de recurrencia, en opinión tanto del monitor médico como del investigador;
    E.5 End points
    E.5.1Primary end point(s)
    Metastasis free survival (MFS)
    Supervivencia sin metástasis (MFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    MFS is defined as the time from randomization to radiographic progression or death on study (death within 112 days of treatment discontinuation without evidence of radiographic progression), whichever occurs first.
    MFS se define como el periodo que va de la aleatorización a la progresión radiográfica o al fallecimiento durante el estudio (fallecimiento en un plazo de 112 días después de la interrupción del tratamiento sin indicios de progresión radiográfica), lo que ocurra en primer lugar.
    E.5.2Secondary end point(s)
    Overall survival
    Supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    The time from randomization to death due to any cause.
    el tiempo desde la aleatorización hasta el fallecimiento por cualquier causa.
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Calidad de vida
    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) 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.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    Italy
    Korea, Republic of
    Malaysia
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Russian Federation
    Serbia
    Singapore
    Slovakia
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    United Kingdom
    United States
    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
    Study drug administration should continue until radiographic progression as specified in the protocol.
    La administración del medicamento del estudio debe continuar hasta que se produzca la progresión radiográfica, tal y como se especifica en el protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 390
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1170
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 860
    F.4.2.2In the whole clinical trial 1560
    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)
    Patients will have safety follow up approx. 30 days after the last dose of study drug. If a new antineoplastic treatment is initiated before 30 days after the last dose of study drug, then safety follow up will occur immediately before starting the new treatment. Long term follow up assessments will include monitoring for survival status, new antineoplastic therapies for prostate cancer, opiate medications, skeletal related events, and interventions due to locoregional progression.
    Segui de la seguridad se hara aprox.30 días después de la última dosis.Si se inicia un nuevo trata. antineoplásico antes de que pasen 30 días desde la toma de la última dosis,el segu. de la seguridad tendrá lugar justo antes de comenzar el nuevo trata.Las evalua. de segur.consistirán en la supervisión del estado de supervivencia, de los nuevos trata. antineoplásicos para cáncer de próstata,de los medica opiáceos,de los aconteci. óseos y las intervenciones a causa de la progresión locorregional.
    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 Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-28
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