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    The EU Clinical Trials Register currently displays   42733   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-001694-32
    Sponsor's Protocol Code Number:9785-CL-0123
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 number2016-001694-32
    A.3Full title of the trial
    A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
    Studio di estensione, di fase 2, in aperto per soggetti affetti da tumore alla prostata che in precedenza hanno partecipato a uno studio clinico su enzalutamide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to provide access to continued treatment for subjects with prostate cancer who are currently participating in an enzalutamide clinical study
    Studio per fornire accesso continuato al trattamento con enzalutamide a soggetti affetti da tumore alla prostata che stanno partecipando a uno studio clinico su enzalutamide
    A.3.2Name or abbreviated title of the trial where available
    Protocol 9785-CL-0123
    Protocollo 9785-CL-0123
    A.4.1Sponsor's protocol code number9785-CL-0123
    A.5.4Other Identifiers
    Name:INDNumber:74,563
    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.
    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 AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715455050
    B.5.5Fax number0031715455051
    B.5.6E-mailastellas.registration@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 - "40 MG - CAPSULA MOLLE - USO ORALE - BLISTER (PVC/PCTFE/ALU)" 112 CAPSULE
    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
    D.3.2Product code [Xtandi]
    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.3.9.4EV 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic castration-resistant prostate cancer
    Carcinoma prostatico metastatico resistente alla castrazione
    E.1.1.1Medical condition in easily understood language
    cancer of the prostate
    tumore alla prostata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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
    The objective of the study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide (as assessed by the investigator) from their participation
    in an enzalutamide clinical study sponsored by Astellas or Medivation Inc., a wholly owned subsidiary of Pfizer Inc. (Medivation/Pfizer) which
    has completed, at a minimum, the primary analysis or the study specified evaluation period.
    L’obietto dello studio è acquisire dati sulla sicurezza a lungo termine relativamente a soggetti che continuano a trarre beneficio clinico dal trattamento con enzalutamide (in base alla valutazione dello Sperimentatore) dalla loro partecipazione in uno studio clinico su enzalutamide sponsorizzato da Astellas o Medivation, Inc., una società interamente controllata di Pfizer Inc. (Medivation/Pfizer), per cui sia stata completata almeno l’analisi primaria o il periodo di valutazione specifico dello studio.
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    1. IRB/ IEC approved written Informed Consent and privacy language as per national regulations [e.g., Health Insurance Portability and Accountability Act authorization for the United States sites] must be
    obtained from the subject prior to any study-related procedures.
    2. Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
    3. Subjects are able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment a change is needed to the subject's regimen approval (e.g., dose change in androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
    4. Subject is able to swallow enzalutamide capsules and comply with study requirements. 5. Subject and his female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective† and 1 must be a barrier method‡ throughout the study and for 3 months after final enzalutamide administration.
    Two acceptable forms of birth control include:
    ‡ Condom (barrier method of contraception), AND
    † In addition to a condom, 1 of the following acceptable forms of contraception is required:
    ¿ Established use of oral, injected or implanted hormonal methods of contraception
    ¿ Placement of an intrauterine device or intrauterine system
    ¿ Tubal ligation
    ¿ Vasectomy or other surgical castration prior to initial screening.
    6. Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
    7. Subject agrees not to participate in another interventional study while on treatment.
    Waivers to the inclusion criteria will NOT be allowed
    I soggetti risulteranno idonei per lo studio se vengono soddisfatte tutte le seguenti condizioni:
    1. Prima di qualunque procedura correlata allo studio è necessario ottenere dal soggetto il consenso informato e il consenso per l’Informativa sulla privacy per iscritto, come approvati dall’IRB/IEC, e come da normativa nazionale (ad es., la Health Insurance Portability and Accountability Act authorization per i centri ubicati negli Stati Uniti).
    2. I soggetti devono essere attualmente in trattamento con enzalutamide per il tumore alla prostata nell’ambito di uno studio sponsorizzato da Astellas o Medivation/Pfizer e, sulla base della valutazione da parte dello Sperimentatore, devono trarre beneficio dalla continuazione del trattamento. I soggetti che stanno partecipando a sperimentazioni avviate su iniziativa dello Sperimentatore non sono idonei.
    3. I soggetti devono essere in grado di continuare ad assumere il regime di trattamento ricevuto nell’ambito dello studio precedente. Nel caso in cui, secondo la valutazione dello Sperimentatore, si renda necessaria una modifica al regime del soggetto [ad es., una modifica della dose relativamente alla terapia di deprivazione androgenica (Androgen Deprivation Therapy, ADT) o l’interruzione di una terapia di combinazione], prima dell’arruolamento è necessaria l’approvazione del supervisore medico.
    4. I soggetti devono essere in grado di deglutire le capsule di enzalutamide e di attenersi ai requisiti dello studio.
    5. I soggetti e le partner di sesso femminile in grado di procreare, devono continuare ad utilizzare, per l’intera durata dello studio e per 3 mesi dopo la somministrazione finale di enzalutamide, 2 metodi contraccettivi, di cui 1 deve essere un metodo contraccettivo altamente efficace† e 1 deve essere un metodo a barriera‡.
    Due metodi contraccettivi accettabili comprendono:
    ‡ Il preservativo (metodo contraccettivo a barriera), E
    † in aggiunta a un preservativo, è richiesto 1 dei seguenti metodi contraccettivi accettabili:
    ¿ l’uso accertato di contraccettivi ormonali orali, iniettabili o impiantati,
    ¿ il posizionamento di un dispositivo intrauterino o di un sistema intrauterino,
    ¿ legatura delle tube,
    ¿ vasectomia o altra tipologia di castrazione chirurgica prima dello screening iniziale.
    6. I soggetti devono accettare di evitare la donazione di sperma durante lo studio e per almeno 3 mesi dopo la somministrazione finale di enzalutamide.
    7. I soggetti devono accettare di non partecipare ad altri studi interventistici durante il trattamento.
    NON sono ammesse deroghe ai criteri di inclusione.
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:
    1. Subject met any of the discontinuation criteria or progressed on the current enzalutamide clinical study in which they are enrolling from.
    2. Subject requires treatment with or plans to use either of the following:
    ¿ New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous
    studies which was stopped and then restarted during this study does not represent new treatment (e.g., ADT).
    ¿ Investigational therapy other than enzalutamide
    3. Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
    4. Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.
    Waivers to the exclusion criteria will NOT be allowed.
    I soggetti saranno esclusi dalla partecipazione se viene soddisfatta una qualunque delle seguenti condizioni:
    1. I soggetti soddisfano uno qualunque dei criteri di interruzione o presentano una progressione nello studio clinico attuale su enzalutamide da cui vengono arruolati.
    2. I soggetti necessitano di un trattamento o prevedono di utilizzare uno dei seguenti:
    ¿ Nuova terapia sistemica antitumorale (è consentita la radioterapia palliativa). Il trattamento con agenti somministrati durante studi precedenti, interrotto e quindi riavviato nell’ambito del presente studio, non costituisce un “nuovo trattamento” (ad es., l’ADT).
    ¿ Terapia sperimentale diversa da enzalutamide.
    3. Soggetti che stiano attualmente partecipando a una sperimentazione interventistica avviata su iniziativa dello Sperimentatore e che stanno ricevendo enzalutamide.
    4. Soggetti che abbiano qualunque malattia, infezione concomitante o condizione di comorbilità che, secondo il parere dello Sperimentatore, interferisce con la capacità dei soggetti di partecipare allo studio, li pone a un rischio inutile o che complica l’interpretazione dei dati.
    NON sono ammesse deroghe ai criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    N/A
    N/A
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    In Aperto: il valore corretto per il campo E.8.1.2 è SI
    Open: correct selection for E.8.1.2 is YES
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA118
    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
    Canada
    Chile
    Czechia
    Denmark
    Finland
    France
    Georgia
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Moldova, Republic of
    Netherlands
    New Zealand
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    LVLS
    LVLS
    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 months5
    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 months5
    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 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: 117
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 353
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 222
    F.4.2.2In the whole clinical trial 470
    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)
    N/A
    N/A
    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 Decision2018-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-29
    P. End of Trial
    P.End of Trial StatusOngoing
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