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    Summary
    EudraCT Number:2011-000621-80
    Sponsor's Protocol Code Number:212082BCA2001
    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:2012-09-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000621-80
    A.3Full title of the trial
    Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
    Studio randomizzato in aperto di abiraterone acetato (JNJ-212082) piu' prednisone con o senza exemestane, condotto su donne in post-menopausa affette da carcinoma mammario metastatico ER+ in progressione dopo terapia con letrozolo o anastrozolo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
    Uno studio su Abiraterone Acetato piu Prednisone con o senza Exemestane in donne post-menopausa affette da carcinoma mammario metastatico ER+ in progressione dopo terapia con letrozolo o anastrozolo
    A.4.1Sponsor's protocol code number212082BCA2001
    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 SponsorJANSSEN-CILAG INTERNATIONAL N.V.
    B.1.3.4CountryBelgium
    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 supportJANSSEN-CILAG SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG INTERNATIONAL NV
    B.5.2Functional name of contact pointCLINICAL REGISTRY GROUP
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code23333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 5242166
    B.5.5Fax number+31 71 5242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 No
    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 nameABIRATERONE ACETATE
    D.3.2Product code NA
    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 INNABIRATERONE
    D.3.9.1CAS number 154229-18-2
    D.3.9.4EV Substance CodeSUB07361MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 50-24-8
    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.IMP: 3
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Coated 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.3.9.1CAS number 107868-30-4
    D.3.9.4EV Substance CodeSUB07492MIG
    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
    metastatic brest cancer
    tumore della mammella metastatizzato
    E.1.1.1Medical condition in easily understood language
    brest cancer
    tumore del seno
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast 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 primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer progressing after letrozole or anastrozole therapy
    L'obiettivo primario è valutare la sicurezza e l'efficacia di abiraterone acetato più prednisone e abiraterone acetato più prednisone in combinazione con exemestano, in entrambi i casi rispetto al solo exemestano, nelle donne in post-menopausa con carcinoma mammario metastatico ER+ in progressione dopo terapia con letrozolo o anastrozolo.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess abiraterone acetate plus prednisone and abiraterone acetate plus prednisone combined with exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer progressing after letrozole or anastrozole therapy, with respect to the following: •Overall survival •Overall response rate •Patient-reported outcomes (PROs) EORTC-C30, EQ-5D-5L, and BPI-SF pain intensity scale •Endocrine markers estradiol, testosterone, estrone, and other biomarkers •PK characterization of abiraterone and exemestane
    Gli obiettivi secondari sono valutare abiraterone acetato più prednisone e abiraterone acetato più prednisone in combinazione con exemestano, in entrambi i casi rispetto al solo exemestano, nelle donne in post-menopausa con carcinoma mammario metastatico ER+ in progressione dopo terapia con letrozolo o anastrozolo. La valutazione riguarda gli aspetti seguenti: •Sopravvivenza globale •Tasso di risposta globale •Risultati riferiti dai pazienti (PRO), EORTC-C30, EQ-5D-5L e scala di intensità del dolore BPI-SF •Marcatori endocrini di estradiolo, testosterone, estrone e altri biomarcatori •Caratterizzazione farmacocinetica (PK) di abiraterone ed exemestano
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Woman >=18 years of age and postmenopausal determined by one of the following: •bilateral, surgical oophorectomy •age >=60 years •age <60 years, with amenorrhea >=24 months and follicle-stimulating hormone and luteinizing hormone concentrations within postmenopausal range 2. Subjects with ER+, Her2- metastatic breast cancer, confirmed within 7 days before randomization with FFPE tissue from either primary or metastatic breast cancer site. In a subject with multiple biopsies of metastatic sites, the most recent biopsy prior to study entry should be submitted for evaluation of hormone receptor status. 3. Subjects with disease confined only to bone may be included but subjects with purely sclerotic lesions may not participate in the study. 4. Disease must have been sensitive to anastrozole or letrozole therapy prior to disease progression. Sensitivity to anastrozole or letrozole is defined as either stable disease or better for >=6 months in the metastatic setting or relapse free for >=2 years in the adjuvant setting. 5.No more than two prior lines of therapy in the metastatic setting, of which no more than one was chemotherapy [Note: Simultaneous combination treatment is considered one line of therapy.] 6. Eastern Cooperative Oncology Group (ECOG) performance status score of <=1 7. Clinical laboratory values during Screening: •hemoglobin >=10.0 g/dL •neutrophils >=1.5 x 10^9/L •platelets >=100 x 10^9/L Note: Subjects need to meet the above 3 criteria independent of growth factors and transfusions •total bilirubin <=1.5 x upper limit of normal (ULN) •alanine (ALT) and aspartate (AST) aminotransferase <=2.5xULN •alkaline phosphatase <=6xULN unless bone metastases with no liver disorder •serum creatinine <1.5xULN or creatinine clearance >=50 mL/min •serum potassium >=3.5 mM •serum albumin >=3.0 g/dL •prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits [Exception: PT and international normalized ratio (INR) will be abnormally prolonged in subjects taking warfarin.] 8. Systolic blood pressure <160 mm Hg and diastolic blood pressure <95 mm Hg [Note: Hypertension controlled by antihypertensive therapy is permitted]. 9. Cardiac ejection fraction >=50% measured by MUGA or ECHO done within 4 weeks before randomization 10. A bisphosphonate or denosumab may be initiated on the same day as the assigned study. 11 Willing and able to adhere to prohibitions and restrictions specified in his protocol 12 Signs an informed consent document within 4 weeks before randomization indicating she understands the purpose of and procedures required for the study and is willing to participate in the study 13 Signs the informed consent document within 4 weeks before randomization for pharmacogenomics research indicating willingness to participate in the pharmacogenomic component of the study, where local regulations permit. [Note: Refusal to give consent for this component does not exclude a subject from participation in this clinical study.]
    1.Donne di età superiore ai 18 anni e in post-menopausa sulla base di uno dei seguenti criteri: •Ovariectomia chirurgica bilaterale •età maggiore o uguale a 60 anni •età inferiore o uguale a 60 anni, con amenorrea da più di 24 mesi e concentrazioni di ormone follicolo-stimolante e ormone luteinizzante nei range compatibili con quelli di post-menopausa 2. Soggetti con carcinoma mammario metastatico Her2- ER+, confermato entro 7 giorni dalla randomizzazione con tessuto FFPE (incluso in paraffina e fissato in formalina) ottenuto da localizzazione di carcinoma mammario primitivo o metastatico. In un soggetto con biopsie multiple dei siti metastatici, la biopsia più recente effettuata prima dell'ingresso nello studio deve essere inviata per la valutazione dello stato dei recettori ormonali 3. I soggetti con malattia limitata alle ossa possono essere inclusi, mentre i soggetti con lesioni puramente sclerotiche non possono partecipare allo studio (vedere Sezione 9.2.1). 4.La malattia deve essere risultata sensibile alla terapia con anastrozolo o letrozolo prima della progressione. La sensibilità a anastrozolo o letrozolo viene definita come stabilità o risposta della malattia metastatica superiore ai 6 mesi oppure assenza di recidive per più di 2 anni nel trattamento in adiuvante. 5.Non più di 2 precedenti linee di terapia per la malattia metastatica, delle quali non più di 1 di tipo chemioterapico [nota: le combinazioni terapeutiche vengono considerate come unica linea di terapia] 6. Stato ECOG (Eastern Cooperative Oncology Group) ≤1 7.Valori delle analisi cliniche di laboratorio allo screening: • emoglobina ≥10,0 g/dl • neutrofili ≥ 1,5 x 109/l • piastrine ≥ 100 x 109/l (NOTA: i soggetti devono soddisfare i 3 criteri sopra indipendentemente dai fattori di crescita e dalle trasfusioni) • bilirubina totale ≤1,5x il limite superiore della norma (ULN) • alanina (ALT) e aspartato (AST) aminotransferasi ≤2,5xULN • fosfatasi alcalina ≤6xULN tranne in caso di metastasi ossea senza disturbo epatico • creatinina nel siero &lt;1,5xULN oppure clearance della creatinina &gt;50 ml/min • potassio nel siero ≥3,5 mM • albumina sierica ≥3,0 g/dl • tempo di protrombina (PT) e tempo parziale di protrombina (PTT) entro i limiti europei [eccezione: PT e il rapporto normalizzato internazionale (INR) saranno prolungati in modo anomalo nei soggetti che assumono warfarina] 8.Pressione sanguigna sistolica &lt;160 mmHg e pressione sanguigna diastolica &lt;95 mmHg [nota: è ammesso il controllo dell'ipertensione tramite terapia antiipertensiva] 9.Frazione di eiezione cardiaca ≥50% misurata tramite MUGA o ECHO, 4 settimane prima della randomizzazione 10.Criterio modificato tramite emendamento 10. L'assunzione di bifosfonato o denosumab può iniziare lo stesso giorno del trattamento di studio assegnato 11. Volontà e capacità di conformarsi ai divieti e alle restrizioni specificati in questo protocollo 12.Firma di un modulo di consenso informato entro 4 settimane dalla randomizzazione indicante che il soggetto comprende lo scopo dello studio e le relative procedure e che intende prendervi parte 13.Firma di un modulo di consenso informato entro 4 settimane dalla randomizzazione per la ricerca farmacogenomica, indicante che il soggetto intende partecipare alla componente farmacogenomica dello studio, ove consentito dai regolamenti locali [nota: il rifiuto di fornire il consenso per partecipare a questa ricerca non esclude i soggetti dalla partecipazione allo studio clinico]
    E.4Principal exclusion criteria
    1. Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor [Note: Prior treatment with ketoconazole for <= 7 days is permitted and topical formulations of ketoconazole are permitted]
    2. Anticancer immunotherapy or investigational agent within 4 weeks before randomization, or anticancer radiotherapy (except palliative) or anticancer endocrine therapy within 2 weeks before randomization [Note: Potential subjects must not have taken anastrozole, letrozole fulvestrant, or any chemotherapy for at least 2 weeks (bevacizumab for at least 3 weeks) before randomization.]
    3. Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
    4. Clinical or biochemical evidence of hyperaldosteronism or hypopituitarism 5. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments
    6. Major thoracic or abdominal surgery or significant traumatic injury with 4 weeks before randomization or plans surgery during study participation or within 4 weeks after the last dose of study drug [Note: Patients with planned surgical procedures to be conducted under local anesthesia are not excluded from the study.]
    7. Persistent >=Grade 2 toxicity from any cause [Note: Chemotherapyinduced alopecia and Grade 2 peripheral neuropathy are allowed.]
    8. Symptomatic central nervous system disease or leptomeningeal disease
    9. Gastrointestinal disorder interfering with study drug absorption 10. Active or uncontrolled disease that may require oral corticosteroid therapy
    11. Positive serology for hepatitis B surface antigen or hepatitis C antibody
    12. Active or symptomatic viral hepatitis or chronic liver disease
    13. History of clinically significant heart disease, ie, myocardial infarction or arterial thrombotic event within 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
    14. Known allergies, hypersensitivity, or intolerance to abiraterone acetate, exemestane, prednisone, or their excipients
    15. Contraindications to the use of exemestane or prednisone per local prescribing information
    16. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study drug or is currently enrolled in an investigational study
    1. Precedente trattamento con exemestano, chetoconazolo, aminoglutetimide o un inibitore di CYP17 [nota: un trattamento precedente con chetoconazolo per meno di 7 giorni è ammesso, così come quello con formulazioni topiche di chetoconazolo] 2. Immunoterapia antineoplastica o agente sperimentale nelle 4 settimane precedenti la randomizzazione oppure radioterapia (tranne palliativa) o ormonoterapia antitumorale nelle 2 settimane precedenti la randomizzazione [nota: i potenziali soggetti non devono aver assunto anastrozolo, letrozolo, fulvestrant o un qualsiasi agente chemioterapico almeno nelle 2 settimane (bevacizumab almeno 3 settimane) precedenti la randomizzazione] 3.Patologia non maligna grave o non controllata, compresa infezione attiva o non controllata 4. Evidenza clinica o biochimica di iperaldosteronismo o ipopituitarismo 5. Qualsiasi condizione che, a parere dello sperimentatore, comprometterebbe il benessere del paziente o potrebbe prevenire, limitare o confondere le valutazioni specificate dal protocollo 6. Importante intervento chirurgico al torace o all'addome oppure lesione traumatica significativa nelle 4 settimane precedenti la randomizzazione oppure intervento chirurgico pianificato durante la partecipazione allo studio o nelle 4 settimane dopo l'ultima dose di farmaco sperimentale [nota: i pazienti con procedure chirurgiche programmate da effettuarsi in anestesia locale non sono esclusi dallo studio] 7. Tossicità persistente di grado superiore a 2 per una qualsiasi causa [nota: alopecia indotta da chemioterapia e neuropatia periferica di grado 2 sono ammesse] 8. Patologia sintomatica al sistema nervoso centrale o patologia leptomeningea 9. Disturbo gastrointestinale che interferisce con l'assorbimento del farmaco sperimentale 10. Criterio modificato tramite emendamento 10.1 Patologia attiva o incontrollata che può necessitare di terapia orale a base di corticosteroidi 11. Sierologia positiva per antigene di superficie dell'epatite B o anticorpo dell'epatite C 12. Epatite virale sintomatica o attiva oppure epatopatia cronica 13. Storia di patologia cardiaca clinicamente significativa, cioè infarto miocardico o evento trombotico arterioso nei 6 mesi precedenti, angina grave o instabile o patologia cardiaca di classe III o IV della New York Heart Association (NYHA) 14. Allergie note, ipersensibilità o intolleranza ad abiraterone acetato, examestane, prednisone o relativi eccipienti 15. Controindicazioni all'uso di exemestane o prednisone per informazioni di prescrizione locali 16. Assunzione di un farmaco sperimentale (compresi vaccini sperimentali) o uso di un dispositivo medico sperimentale invasivo nelle 4 settimane precedenti la prima dose programmata del farmaco dello studio oppure arruolamento in atto in uno studio sperimentale
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival
    Sopravvivenza senza progressione di malattia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 1.5 years
    Fino a circa 1.5 anni
    E.5.2Secondary end point(s)
    1. Overall survival 2. Overall response rate to treatment 3. Patient-reported outcomes 4. Pharmacodynamics 5. Pharmacokinetics
    1. Sopravvivenza globale 2. Tasso di risposta globale al trattamento 3.Risultati riferiti dai pazienti 4. Farmacodinamica 5 Farmacocinetica
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 3.5 years 2. Up to 1.5 years 3. Up to approximately 3.5 years 4. Up to approximately 1.5 years 5. Approximately 4 months
    1. Fino a circa 3.5 anni 2. Fino a circa 1.5 anni 3. Fino a circa 3.5 anni 4. Fino a circa 1.5 anni 5. Circa 4 mesi
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA51
    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
    Korea, Republic of
    Russian Federation
    Ukraine
    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
    The last follow-up of the last subject participating in the study
    ULTIMO FOLLOW-UP DELL'ULTIMO PAZIENTE IN STUDIO
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months42
    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: 0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects should enter the Follow-Up phase regardless of reason for
    study drug discontinuation and should be monitored every 3 months
    (±7 days) for up to 36 months (3 years) or until death, loss to followup,
    consent withdrawal, or AA development in this indication is
    discontinued
    I pazienti dovrebbero entrare nella fase di Follow-Up indipendentemente dal motivo dell'interruzione dell'assunzione del farmaco in studio e dovrebbero essere monitorati ogni 3 mesi (±7 giorni) fino a 36 mesi (3 anni) o fino a morte, perdita al follow up, ritiro del consenso, o per interruzione dello sviluppo di Abiraterone Acetatao in questa indicazione.
    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 Decision2012-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-11
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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