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    Summary
    EudraCT Number:2015-003869-28
    Sponsor's Protocol Code Number:9785-CL-0335
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2018-02-06
    Trial 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 ConcernedItaly - Italian Medicines Agency
    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).
    Studio multinazionale di fase 3, randomizzato, in doppio cieco, controllato con placebo, di valutazione dell'efficacia e della sicurezza di enzalutamide associato a terapia di deprivazione androgenica (ADT) rispetto a placebo associato ad ADT in pazienti affetti da carcinoma alla prostata ormone-sensibile metastatico (mHSPC).
    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).
    Studio multinazionale di fase 3, randomizzato, in doppio cieco, e controllato verso placebo, che studia l'efficacia e la sicurezza di enzalutamide associato a terapia di deprivazione androgenica (ADT) rispetto a placebo associato ad ADT in pazienti affetti da carcinoma alla prostata ormone-sensibile metastatico (mHSPC).
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number9785-CL-0335
    A.5.4Other Identifiers
    Name:NDNumber:ND
    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.
    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+31 071 5455050
    B.5.5Fax number+31 071 5455840
    B.5.6E-mailcontact@nl.astellas.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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 nameENZALUTAMIDE
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    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)
    Carcinoma alla prostata ormone-sensibile metastatico (mHSPC)
    E.1.1.1Medical condition in easily understood language
    Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
    Carcinoma alla prostata ormone-sensibile metastatico (mHSPC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    Determinare i benefici di enzalutamide associato ad ADT rispetto a placebo associato ad ADT valutati in base a sopravvivenza libera da progressione radiografica (rPFS) basata su revisione a livello centrale
    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 InventoryShort
    Form [BPI-SF])
    Determinare i benefici di enzalutamide associato ad ADT rispetto a placebo associato ad ADT
    - valutati in base a sopravvivenza globale (OS)
    - valutati in base al tempo alla comparsa del primo Evento Scheletrico Sintomatico (SSE)
    - valutati in base al tempo all'insorgenza di resistenza alla castrazione
    - valutati in base alla Qualità della vita (QoL) (misurata in base al questionario sulla Qualità della vita)
    Questionario Prostata-specifico [QLQ-PR25] / Valutazione funzionale della terapia antitumorale per il carcinoma prostatico [FACT-P] e strumento del gruppo EuroQol a 5 Dimensioni e 5 livelli [EQ-5D-5L])
    - valutati in base al tempo all'inizio di una nuova terapia antineoplastica
    - valutati in base al tempo alla progressione dell'antigene prostata-specifico (PSA)
    - valutati in base a tasso di PSA non rilevabile (< 0,2 ng/ml)
    - valutati in base al Tasso di risposta obiettiva (ORR)
    - valutati in base al peggioramento del dolore (misurato in base al Breve questionario per la valutazione
    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 soggetto è stato diagnosticato adenocarcinoma della prostata confermato istologicamente o citologicamente senza differenziazione neuroendocrina, istologia di cellule a sigillo o piccole cellule;
    Il soggetto è affetto da carcinoma alla prostata metastatico documentato da scintigrafia ossea positiva o lesioni metastatiche rilevate con TAC o RM. I soggetti in cui la diffusione della malattia è limitata ai linfonodi dell'area pelvica non sono eleggibili;
    Una volta randomizzato al giorno 1, il soggetto deve continuare l'ADT con un agonista o antagonista di LHRH durante il trattamento in studio o avere un’anamnesi di orchiectomia bilaterale (ossia castrazione medica o chirurgica);
    Il soggetto presenta stato di performance ECOG (Eastern Cooperative Oncology Group) di 0 o 1 allo screening;
    Il soggetto ha un'aspettativa di vita ≥ 12 mesi secondo la valutazione dello sperimentatore.
    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-α 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
    Il soggetto ha ricevuto in precedenza qualsiasi terapia farmacologica, terapia a base di radiazioni o intervento chirurgico per il carcinoma alla prostata metastatico (le seguenti eccezioni sono consentite):
    * Fino a 3 mesi di ADT con agonisti o antagonisti dell'ormone di rilascio dell'ormone luteinizzante (LHRH) oppure orchiectomia con o senza antiandrogeni concomitanti prima del giorno 1, in assenza di evidenza radiografica di progressione della malattia o aumento dei livelli di PSA prima del giorno 1;
    * I soggetti possono essersi sottoposti a 1 ciclo di radiazioni palliative o terapia chirurgica per il trattamento dei sintomi derivanti da malattia metastatica se la somministrazione risale ad almeno 4 settimane prima del giorno 1;
    *Fino a 6 cicli di terapia con docetaxel e somministrazione finale del trattamento completata entro 2 mesi dal giorno 1 e nessuna evidenza di progressione della malattia durante o dopo il completamento della terapia con docetaxel;
    * Fino a 6 mesi di ADT con agonisti o antagonisti dell'ormone di rilascio dell'ormone luteinizzante (LHRH) oppure orchiectomia con o senza antiandrogeni concomitanti prima del giorno 1 se il soggetto è stato trattato con docetaxel, in assenza di evidenza radiografica di progressione della malattia o aumento dei livelli di PSA prima del giorno 1;
    *Precedente ADT somministrata per un periodo di durata < 36 mesi e > 9 mesi prima della randomizzazione come terapia neoadiuvante/adiuvante.
    - Il soggetto ha ricevuto trattamento con inibitori di 5-α reduttasi (finasteride, dutasteride) entro 4 settimane prima del giorno 1.
    - Il soggetto ha ricevuto trattamento con estrogeni, ciproterone acetato o androgeni entro 4 settimane
    prima del giorno 1.
    - Il soggetto ha ricevuto trattamento con glucocorticoidi sistemici in dosi superiori all'equivalente di 10 mg al giorno di prednisone entro 4 settimane prima del giorno 1.
    - Il soggetto ha ricevuto trattamento con farmaci erboristici che hanno nota attività ormonale contro il tumore alla prostata e/o notoriamente riducono i livelli di PSA entro 4 settimane prima del giorno 1.
    - Il soggetto ha ricevuto in precedenza aminoglutetimide, ketoconazolo, abiraterone acetato o enzalutamide per il trattamento del carcinoma prostatico o ha partecipato a uno studio clinico con un agente sperimentale che inibisce il recettore androgenico o la sintesi androgenica (per esempio, 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.
    rPFS: Definito come il tempo dalla randomizzazione alla prima evidenza obiettiva di progressione radiografica della malattia valutata in base a revisione centrale o decesso (definito come decesso per qualsiasi causa entro 24 settimane dall'interruzione del trattamento con il farmaco in studio), qualunque di questi eventi si verifichi per primo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ITT
    ITT
    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
    - OS
    - Tempo alla comparsa del primo SSE
    - Tempo all'insorgenza di resistenza alla castrazione
    - Tempo al peggioramento della QoL
    - Tempo all'inizio di una nuova terapia antineoplastica
    - Tempo alla progressione di PSA (≥ 2 ng/ml) (criteri del Gruppo di Lavoro sul Carcinoma Prostatico 2)
    - tasso di PSA non rilevabile (< 0,2 ng/ml)
    - ORR
    - Tempo alla progressione del dolore
    E.5.2.1Timepoint(s) of evaluation of this end point
    ITT
    ITT
    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 concerned8
    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 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
    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
    al raggiungimento dei 510 rPFS eventi
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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.1.1Number of subjects for this age range: 1
    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.1.2.1Number 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 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 state48
    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
    Continuare con il trattamento standard
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-17
    P. End of Trial
    P.End of Trial StatusRestarted
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