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    Summary
    EudraCT Number:2015-003869-28
    Sponsor's Protocol Code Number:9785-CL-0335
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2016-02-03
    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 number2015-003869-28
    A.3Full title of the trial
    A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC).
    Estudio de eficacia y seguridad de fase 3, multinacional, aleatorizado, doble ciego y controlado con placebo de enzalutamida más tratamiento de privación androgénica (TPA) frente a placebo más TPA en pacientes con cáncer de próstata metastásico hormonosensible (CPmHS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multinational study, Phase 3, Randomized, Double-blind, and controlled against a Placebo that studies the Efficacy and the Safety of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC).
    Un estudio multinacional, fase 3, aleatorizado, doble ciego y controlado con un placebo que estudia la eficacia y la seguridad de la Enzalutamida más terapia de deprivación androgénica (ADT) comparado frente a placebo más ADT en pacientes con cáncer de próstata metastático hormonosensible (mHSPC).
    A.3.2Name or abbreviated title of the trial where available
    Protocol 9785-CL-0335
    Protocolo 9785-CL-0335
    A.4.1Sponsor's protocol code number9785-CL-0335
    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 SponsorAstellas Pharma Global Development, Inc (APGD)
    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 supportAstellas Pharma Global Development, Inc (APGD)
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMedivation, Inc and its Subsidiaries
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSlyviusweg 62
    B.5.3.2Town/ citySlyviusweg 62
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+34900 834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.com
    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 nameEnzalutamide
    D.3.2Product code MDV3100
    D.3.4Pharmaceutical form Tablet
    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.3.9.4EV 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 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
    Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
    Cáncer de próstata metastásico hormonosensible (CPmHS)
    E.1.1.1Medical condition in easily understood language
    Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
    Cáncer de próstata metastásico hormonosensible (CPmHS)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central review
    Determinar el beneficio de enzalutamida más TPA en comparación con placebo más TPA según la SSPr en función de la revisión centralizada.
    E.2.2Secondary objectives of the trial
    To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as
    - assessed by overall survival (OS)
    - assessed by time to first Symptomatic Skeletal Event (SSE)
    - assessed by time to castration resistance
    - assessed by Quality of Life (QoL) (as measured by Quality of Life Prostate-specific Questionnaire [QLQ-PR25] / Functional Assessment of Cancer Therapy-Prostate [FACT-P] and EuroQol Group-5 Dimension-5 Level Instrument [EQ-5D-5L])
    - assessed by time to start of new antineoplastic therapy
    - assessed by time to prostate-specific antigen (PSA) progression
    - assessed by PSA undetectable rate (< 0.2 ng/mL)
    - assessed by objective response rate (ORR)
    - assessed by worsening of pain (as measured by Brief Pain Inventory-Short Form [BPI-SF])
    Para determinar el beneficio de Enzalutamida además ADT en comparación con placebo más ADT:
    - Evaluado por la supervivencia global (SG)
    - Evaluado por el tiempo hasta el primer acontecimiento óseo sintomático (SSE).
    - Evaluado por el tiempo a la resistencia a la castración
    - Evaluado por la CdV (conforme al Cuestionario de calidad de vida específico para próstata [QLQ PR25], la FACT P y el Instrumento de 5 dimensiones y 5 niveles del EuroQol Group [EQ 5D 5L]).
    - Evaluado por el tiempo hasta el inicio del nuevo tratamiento antineoplásico.
    - Evaluado por el tiempo hasta la progresión según el PSA
    - Evaluado por la tasa de PSA indetectable (<0,2 ng / mL)
    - Evaluado por la tasa de respuesta objetiva (TRO)
    - Evaluado por el empeoramiento del dolor (medido por el Inventario breve del dolor Cuestionario abreviado [BPI SF]).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.

    - Subject has metastatic prostate cancer documented by positive bone scan or metastatic lesions on CT or MRI scan. Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible.

    - Once randomized at day 1, subject must maintain ADT with an LHRH agonist or antagonist during study treatment or have a history of bilateral orchiectomy (i.e., medical or surgical castration).

    - Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.

    - Subject has an estimated life expectancy of ? 12 months as assessed by the Investigator.
    - Al sujeto se le diagnostica adenocarcinoma de la próstata confirmado histológica o citológicamente sin histología de diferenciación neuroendocrina, células en anillo de sello ni células pequeñas.

    - El sujeto sufre cáncer de próstata metastásico documentado por una gammagrafía ósea positiva o lesiones metastásicas en las exploraciones de TC y RMN. Los sujetos cuya diseminación de la enfermedad esté limitada a los ganglios linfáticos de la zona pélvica no son elegibles.

    - Tras la aleatorización del día 1, el sujeto deberá mantener el TPA con un agonista o antagonista de la LHRH durante el tratamiento del estudio o presentar antecedentes de orquiectomía bilateral (es decir, castración médica o quirúrgica).

    - El sujeto presenta un estado funcional de 0 o 1 según el Eastern Cooperative Oncology Group (ECOG) en la visita de selección.

    - El sujeto tiene una esperanza de vida ? 12 meses según el criterio del investigador.
    E.4Principal exclusion criteria
    - Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
    * Up to 3 months of ADT with luteinizing hormone-releasing hormone (LHRH) agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
    * Subject may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to day 1;
    *Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of day 1 and no evidence of disease progression during or after the completion of docetaxel therapy;
    *Up to 6 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
    *Prior ADT given for < 36 months in duration and > 9 months before randomization as neoadjuvant/adjuvant therapy.

    - Subject received treatment with 5-? reductase inhibitors (finasteride, dutasteride) within 4 weeks prior to day 1.

    - Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks
    prior to day 1.

    - Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1.

    - Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.

    - Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for the treatment of prostate cancer or participation in a clinical study of an investigational agent that inhibits the androgen receptor or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
    - Aquellos sujetos que hayan recibido anteriormente farmacoterapia, radioterapia o se hayan sometido a cirugía para cáncer de próstata metastásico (se permiten las siguientes excepciones):
    * Hasta 3 meses de TPA con agonistas o antagonistas de la LHRH u orquiectomía con o sin antiandrógenos simultáneos antes del día 1, sin evidencia radiográfica de progresión de la enfermedad ni aumento de los niveles de PSA antes del día 1.
    * El sujeto puede someterse a 1 ciclo de radioterapia paliativa o tratamiento quirúrgico para tratar los síntomas provocados por la enfermedad metastásica si se administró como mínimo 4 semanas antes del día 1.
    * Hasta 6 ciclos de tratamiento con docetaxel si la última administración del tratamiento tuvo lugar 2 meses antes del día 1 y no existe evidencia de progresión de la enfermedad durante o después de la finalización del tratamiento con docetaxel.
    * Hasta 6 meses de TPA con agonistas o antagonistas de la LHRH u orquiectomía con o sin antiandrógenos simultáneos antes del día 1 si el sujeto fue tratado con docetaxel, sin evidencia radiográfica de progresión de la enfermedad ni aumento de los niveles de PSA antes del día 1.
    * TPA previo administrado durante < 36 meses de duración y > 9 meses antes de la aleatorización como tratamiento adyuvante o neoadyuvante.

    - El sujeto ha recibido tratamiento con inhibidores de la 5 ? reductasa (finasterida, dutasterida) 4 semanas antes del día 1.
    - El sujeto ha recibido tratamiento con estrógenos, acetato de ciproterona y andrógenos 4 semanas antes del día 1.
    - El sujeto recibió tratamiento con glucocorticoides sistémicos a dosis superiores al equivalente de 10 mg al día de prednisona 4 semanas antes del día 1.
    - El sujeto recibió tratamiento con medicamentos herbarios con actividad hormonal conocida contra el cáncer de próstata o que se sabe que reducen los niveles de PSA 4 semanas antes del día 1.
    - El sujeto recibió tratamiento previo con aminoglutetimida, ketoconazol, acetato de abiraterona o enzalutamida contra el cáncer de próstata o participó en un estudio clínico de un fármaco en investigación que inhibiera el RA o la síntesis androgénica (por ejemplo, TAK 700, ARN 509, ODM 201).
    E.5 End points
    E.5.1Primary end point(s)
    rPFS: Defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review or death (defined as death from any cause within 24 weeks from study drug discontinuation), whichever occurs first.
    SSPr: Definida como el tiempo desde la aleatorización hasta la primera evidencia objetiva de progresión radiográfica de la enfermedad, según el revisor central, o fallecimiento (definido como muerte por cualquier causa en el plazo de 24 semanas desde la interrupción del fármaco del estudio), lo que ocurra primero.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ITT
    Intención de tratamiento
    E.5.2Secondary end point(s)
    - OS
    - Time to first SSE
    - Time to castration resistance
    - Time to deterioration of QoL
    - Time to initiation of new antineoplastic therapy
    - Time to PSA progression (? 2 ng/mL) (Prostate Cancer Clinical Trials Working Group 2 criteria)
    - PSA undetectable rate (< 0.2 ng/mL)
    - ORR
    - Time to pain progression
    - SG
    - Tiempo hasta el primer SSE.
    - Tiempo hasta resistencia a la castración.
    - Tiempo hasta el deterioro de la CdV.
    - Tiempo hasta el inicio de un nuevo tratamiento antineoplásico.
    - Tiempo hasta la progresión según el PSA (? 2 ng/ml) (criterios del Prostate Cancer Clinical Trials Working Group 2).
    - Tasa indetectable de PSA (< 0,2 ng/ml).
    - TRO
    - Tiempo hasta la progresión del dolor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ITT
    Intención de tratamiento
    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 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 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 No
    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 EEA135
    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
    Belgium
    Bulgaria
    Canada
    Chile
    China
    Denmark
    Finland
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Ukraine
    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
    At the time the required minimum of 510 rPFS events has been occured
    El momento en el que se hayan producido 510 acontecimientos de SSPr (progresión radiográfica o fallecimiento en el estudio).
    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 months3
    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 months3
    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: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 550
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1100
    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)
    continue with standard of care treatment
    Continuar con el tratamiento estándar
    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 Decision2016-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-08
    P. End of Trial
    P.End of Trial StatusRestarted
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