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    Summary
    EudraCT Number:2013-000698-57
    Sponsor's Protocol Code Number:MDV3100-11
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000698-57
    A.3Full title of the trial
    A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Clinical Activity and Safety
    of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple-Negative
    Breast Cancer
    Studio di fase 2, a braccio singolo, in aperto, multicentrico, per la valutazione dell'efficacia clinica e della sicurezza dell'Enzalutamide in pazienti affette da cancro della mammella triplo negativo in stadio avanzato, positivo al recettore degli androgeni
    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 Activity of Enzalutamide in Women Whose Breast Cancer Expresses the Androgen Receptor but Does Not Express Estrogen or Progesterone Receptors, and is Not Amplified for the Epidermal Growth Factor Receptor, HER2
    Studio multinazionale per valutare dell'efficacia clinica e della sicurezza di Enzalutamide in donne di cui il cancro al seno esprime il recettore degli androgeni ma non esprime estrogeni o recettori del progesterone, e non è amplificata dal recettore del fattore di crescita dell'epidermide, HER2
    A.4.1Sponsor's protocol code numberMDV3100-11
    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.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 pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address525 Market Street, 36th Floor
    B.5.3.2Town/ citySan Francisco
    B.5.3.3Post codeCA 94105
    B.5.3.4CountryUnited States
    B.5.6E-mailinfomdv3100-11trial@medivation.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 Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Capsule
    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.3.9.3Other descriptive nameMDV3100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Breast Cancer
    Carcinoma Mammario
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Carcinoma Mammario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast 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
    The primary objective is to determine clinical benefit rate in patients with AR+ triple-negative breast cancer (TNBC).
    L'obiettivo primario è di determinare il tasso di beneficio clinico in pazienti affette da cancro della mammella triplo negativo (TNBC), positivo al recettore degli androgeni (AR+).
    E.2.2Secondary objectives of the trial
    To determine additional measures of clinical benefit including response rate, duration of response and PFS
    To assess the safety, tolerability and PK of enzalutamide and its active metabolite
    Determinare misure aggiuntive di beneficio clinico includendo il tasso, la durata della risposta e la sopravvivenza libera da progressione (PFS);
    Valutare la sicurezza, la tollerabilità e la farmacocinetica (PK)dell'enzalutamide e del suo metabolita attivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Advanced AR+ (any nuclear AR staining by IHC) TNBC, where advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent;
    • Availability of a tumor specimen that enabled the definitive diagnosis of breast cancer;
    • Either measurable disease or bone-only nonmeasurable disease;
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • TNBC AR+ avanzato, dove per malattia in stadio avanzato si intende la malattia metastatica o localmente avanzata non assoggettabile a intervento chirurgico o a radioterapia con intento curativo;
    • Disponibilità di un campione tumorale che abbia permesso la diagnosi conclusiva di cancro della mammella;
    • Malattia misurabile o malattia solo ossea non misurabile;
    • Performance stato secondo l'Eastern Cooperative Oncology Group (ECOG) di 0 o 1.
    E.4Principal exclusion criteria
    • Current or previously treated brain metastasis or active leptomeningeal disease;
    • Current hormone replacement therapy;
    • Abnormal hematology, liver function tests and creatinine laboratory values at screening;
    • History of seizure or any condition that may predispose to seizure;
    • History of loss of consciousness or transient ischemic attack within past 12 months;
    • An active gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease; uncontrolled celiac disease);
    • Treatment with any approved or investigational agent that blocks androgen synthesis or targets the AR (e.g., abiraterone acetate, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700); patients who received treatment for < 28 days or placebo on an investigational study are acceptable;
    • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
    • Metastasi cerebrale in atto o trattata in precedenza oppure malattia leptomeningea in atto;
    • Terapia ormonale sostitutiva in corso;
    • Ematologia anormale, test di funzionalità epatica e valori di laboratorio di creatinina allo screening;
    • Anamnesi di crisi convulsiva o qualsiasi condizione che possa predisporre alle crisi convulsive;
    • Anamnesi di perdita di coscienza o attacco ischemico transitorio nei 12 mesi precedenti;
    • Disturbo gastrointestinale in atto che influisce sull'assorbimento (ad es. gastrectomia, ulcera peptica attiva, malattia celiaca non controllata);
    • Trattamento con qualsiasi farmaco approvato o sperimentale che blocchi la sintesi degli androgeni o sia mirato all'AR (ad es. abiraterone acetato, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700); sono accettabili le pazienti trattate per < 28 giorni o con placebo in uno studio sperimentale;
    • Reazione da ipersensibilità all'ingrediente farmaceutico attivo o a uno qualsiasi dei componenti della capsula, compresi Labrasol, idrossianisolo butilato e idrossitoluene butilato.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical benefit rate, defined as the proportion of evaluable patients with a best response of CR, PR, or SD > 16 weeks
    Tasso di beneficio clinico definito come percentuale di pazienti valutabili la cui risposta migliore è CR, PR o SD ≥ 16 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to disease progression
    Tempo dalla randomizzazione alla progressione della malattia
    E.5.2Secondary end point(s)
    Additional measures include clinical benefit at >24 weeks, best objective response rate, duration of response and PFS, will be evaluated
    Le ulteriori misure che saranno valutate includono il beneficio clinico ≥ 24 settimane, tasso di risposta obiettiva migliore, durata della risposta e PFS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from randomization to disease progression
    Tempo dalla randomizzazione alla progressione della malattia
    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 Yes
    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 Yes
    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 No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Belgium
    Canada
    France
    Germany
    Ireland
    Italy
    Spain
    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 years3
    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 years3
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 80
    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)
    Standard therapy for progressive metastatic breast cancer patients
    Terapia standard per pazienti con carcinoma mammario metastatico progressivo
    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 Decision2013-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
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