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    Summary
    EudraCT Number:2014-002071-29
    Sponsor's Protocol Code Number:ITT012“ELISA”
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-11-04
    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 number2014-002071-29
    A.3Full title of the trial
    A RANDOMIZED PROSPECTIVE MULTICENTRE PHASE II STUDY OF ANDROGEN DEPRIVATION THERAPY (ADT) PLUS RADIOTHERAPY WITH OR WITHOUT ABIRATERONE ACETATE AND PREDNISONE IN LOCALLY ADVANCED VERY HIGH-RISK PROSTATE CANCER:
    ITT012 “ELISA” STUDY
    Studio di fase II multicentrico prospettico randomizzato di trattamento ormonale (ADT) associato a radioterapia, con o senza Abiraterone Acetato e Prednisone, nei pazienti con carcinoma prostatico localmente avanzato a rischio molto elevato (ITT 012 “ELISA” )
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY WITH RADIOTHERAPY TREATMENT WITH ANDROGEN DEPRIVATION THERAPY (ADT) WITH OR WITHOUT ABIRATERONE ACETATE AND PREDNISONE IN CRPC
    STUDIO CON RADIOTERAPIA E TERAPIA DI DEPRIVAZIONE ANDROGENICA CON O SENZA ABIRATERONE ACETATO PIù PREDNISONE IN CRPC
    A.3.2Name or abbreviated title of the trial where available
    ITT012“ELISA”
    ITT012“ELISA”
    A.4.1Sponsor's protocol code numberITT012“ELISA”
    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 SponsorDIPARTIMENTO DI ONCOLOGIA MEDICA USL8
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportjanssen cilag international
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportITT
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDIPARTIMENTO DI ONCOLOGIA MEDICA USL8
    B.5.2Functional name of contact pointU.O ONCOLOGIA MEDICA
    B.5.3 Address:
    B.5.3.1Street AddressVIA PIETRO NENNI 20
    B.5.3.2Town/ cityAREZZO
    B.5.3.3Post code52100
    B.5.3.4CountryItaly
    B.5.4Telephone number+390575255434
    B.5.5Fax number+390575255431
    B.5.6E-mailsergio.bracarda@usl8.toscana.it
    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 zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International S.p.a.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 acetato
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.2.1.1.1Trade name deltacortene
    D.2.1.1.2Name of the Marketing Authorisation holderbruno farmaceutici SPA
    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.3.1Product namePREDNISONE
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.2.1.1.1Trade name CASODEX
    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.3.1Product nameBICALUTAMIDE
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    LOCALLY ADVANCED VERY HIGH-RISK PROSTATE CANCER
    CARCINOMA PROSTATICO LOCALMENTE AVANZATO AD ALTO RISCHIO
    E.1.1.1Medical condition in easily understood language
    PROSTATE CANCER
    TUMORE ALLA PRSTATA
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10029002
    E.1.2Term Neoplasm of the prostate
    E.1.2System Organ Class 100000004864
    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 whether, following an integrated RT approach, Abiraterone Acetate in ombination with low-dose prednisone and ADT is superior to ADT alone in improving EFS in hormone naïve subjects diagnosed with very high-risk prostate cancer.
    L’ obiettivo primario dello studio è:
    Sopravvivenza Libera da Eventi (EFS) rappresentato dall’intervallo tra la randomizzazione e la recidiva biochimica (PSA-relapse), locale, recidiva a distanza o morte per qualsiasi causa.
    E.2.2Secondary objectives of the trial
    Safety; Biochemical Response Rate (PSA Response); overall survival, time to death due to prostate cancer; Biological end-points.
    Sopravvivenza globale (OS)
    Sopravvivenza cancro-specifica.Altri endpoints di efficacia: tasso di risposta biochimica (secondo i criteri PCWG2); sicurezza (sec. criteri RTOG e NCI CTC); endpoints biologici
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Two blood samples of 8 ml each will be drawn at baseline and at the time of disease progression or end of follow-up in responding patients to extract host germline and circulating tumor DNA.
    The following genetic polymorphisms associated with disease progression to castration-resistant prostate cancer will be investigated:
    1) androgen receptor-binding sites (ARRDC3 rs2939244, FLT1 rs9508016, and SKAP1 rs6504145); 2) CYP17A1 gene (rs743572, rs6162, rs6163, and rs1004467); 3) steroid transport proteins encoded by the solute carrier (SLCO) gene family (SLCO2B1 rs12422149 and SLCO1B3 rs4149117) that mediate the uptake of steroids into prostate cancer cells and thereby influence the clinical response to androgen suppression and 4) steroid 5-α-reductase type 2 (SRD5A2, rs523349C) gene that encodes a prostatic enzyme critical for androgen metabolism (irreversible conversion of testosterone into the more potent androgen, dihydrotestosterone).
    The polymorphisms will be investigated in the host germline DNA and in circulating DNA released from tumor to ascertain whether a genetic evolutionary process in the androgen response machinery occurs in tumors that undergo clinical progression.
    L’analisi genetica ha lo scopo di valutare l’importanza delle variazioni di sequenza dei seguenti geni:
    1) steroide 17-alfa-mono-ossigenasi che trasforma due ormoni, il 17-idrossi-progesterone e il 17-idrossi-pregnenolone in ormoni androgeni attivi che stimolano la crescita del tessuto prostatico normale e delle cellule malate in esso contenute;
    2) sito di legame dei recettori dell’ormone testosterone sul DNA; questa regione del gene è molto importante per regolare la stimolazione del testosterone sul tessuto prostatico normale e sulle cellule malate in esso contenute;
    3) sistema di trasporto cellulare degli steroidi (siglato SLCO2B1 e SLCO1B3) che viene impiegato dalle cellule normali, ma soprattutto da quelle malate, per acquisire testosterone dall’ambiente esterno per stimolare la loro crescita;
    4) steroide 5-alfa-reduttasi di tipo 2 che trasforma il testosterone nel suo ormone androgeno molto più potente, il diidrotestosterone che stimola in modo potente la crescita normale e patologica del tessuto prostatico.
    E.3Principal inclusion criteria
    1.Signed informed consent
    2.Histological diagnosis of prostate adenocarcinoma (with Gleason Score and centralized review)
    3.Hormone-Naive Very High-Risk Disease, defined as patients with “Very High Risk Prostate Cancer”, deriving, accordingly to the NCCN definition, to the following Groups:
    A) Patients with multiple (at least two) Risk parameters (stages T3a, N0, M0 / Gleason Score 8-10 / Baseline PSA > 20ng/ml) of the “High-Risk localized disease” group* (*who, according to “note c” may be shifted into the Highest Risk group)
    B) Patients with a Locally Advanced Disease (a stage T3b-T4, N0 M0)
    4.No other prior or concomitant anti-cancer therapy.
    5.Age between 18 and 80 years
    6.Life expectancy > 6 months
    7.PS ≤ 1 (ECOG scale)
    8.ANC ≥ 1.5 x 109/L; PLT ≥ 100 x 109/L; Hb ≥10 g/dl
    9.ASAT and ALAT ≤1.5 times the upper normal limit (UNL) of the institutions; serum bilirubin ≤ 1 time the UNL;
    10.Creatinine ≤1.5 times the UNL
    11.Patients must be accessible for treatment and follow up
    1. Capacità di fornire il proprio consenso informato allo studio.
    2. Diagnosi istologica di carcinoma prostatico con lo specifico Gleason Score.
    3. Pazienti naive alla terapia ormonale con patologia ad alto rischio secondo la definizione delle linee guida del National Comprehensive Cancer Network (NCCN) appartenenti ai seguenti gruppi:
    A) Pazienti con diagnosi di Malattia Localizzata ad alto rischio che presentano almeno due dei seguenti fattori di rischio: Stadio T3a, N0 M0/Gleason score ≥ 8/PSA Basale > 20ng/ml;
    B) Pazienti con diagnosi di Malattia Localmente Avanzata (Stadio T3b - T4, N0 M0);
    4. Nessun altra precedente o concomitante terapia antitumorale;
    5. Età tra i 18 e gli 80 anni;
    6. Aspettativa di vita superiore ai 6 mesi;
    7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1;
    8. Adeguata funzionalità ematologica, epatica e renale (vedere protocollo per dettagli);
    9. capacità di compliance per quanto riguarda le visite programmate, i trattamenti sperimentali, gli esami radiografici e di laboratotio ed altre procedure di studio;
    10. Capacità di deglutire le compresse medicinali;
    11. Consenso ad utilizzare il preservativo od un altro efficace metodo di contraccezione se il paziente ha rapporti con una donna in età fertile oppure consenso ad utilizzare il preservativo se il paziente ha rapporti con una donna in stato di gravidanza.
    E.4Principal exclusion criteria
    1.Distant Metastatic Sites or lymph node involvement
    2.Previous malignancies, except for basal cell skin cancer adequately treated or any other cancer from which the patient has been disease-free for ≥ 5 years
    3.Any of the concomitant illness or medical condition indicated below:
    Serious respiratory or cardiovascular disease (such as: congestive heart failure; previous history of myocardial infarction, angina pectoris or deep venous thrombosis within 6 months from study entry, uncontrolled hypertension or uncontrolled arrhythmias)
    Unstable diabetes mellitus, peptic ulcer or other contraindications to corticosteroids.
    Active infections.
    Significant neurological or psychiatric disorders.
    4.Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with other experimental drug
    1.Metastasi a distanza o coinvolgimento linfonodale documentato con scintigrafia ossea o CT scan;
    2.Precedenti malignità eccetto il cancro della pelle a cellule basali adeguatamente trattato o qualunque altro tipo di cancro da cui il paziente risulti disease-free da almeno 5 anni;
    3.Una delle seguenti condizioni concomitanti di malattia o condizione medica:
    - severa malattia respiratoria o cardiovascolare (come ad esempio: scompenso cardiaco congestizio, precedente storia di infarto del miocardio, angina pectoris o trombosi venosa profonda entro 6 mesi dall'entrata in studio od aritmie incontrollate);
    - diabete mellito instabile, ulcera peptica od altre controindicazioni ai corticosteroidi;
    - infezioni attive;
    - disordini neurologici o psichiatrici significativi;
    - epatite virale attiva o sintomatica o malattia cronica del fegato.
    4.Ipertensione non controllata (pressione sistolica > 160 mmHg o pressione diastolica > 95 mmHg). Ai pazienti con storia di ipertensione è permesso di seguire un trattamento anti-ipertensivo.
    5.Storia di disfunzione surrenalica.
    6.Partecipazione a studi clinici con altri agenti sperimentali o qualunque procedura invasiva chirurgica entro 30 giorni dall'entrata in studio.
    7.Qualunque trattamento medico precedente, RT, o chirurgia per il cancro alla prostata. Analoghi LH-RH od orchiectomia con o senza anti-androgeni concomitanti entro 2 settimane dalla randomizzazione sono permessi, premesso che sia disponibile un recente valore basale del PSA.
    8.Qualunque condizione medica che richieda una dose sistemica più alta di corticosteroidi rispetto ai 5 mg di prednisolone 2 volte al giorno.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is event‑free survival (EFS) and will be measured from the date of randomization to the first occurrence of biochemical (PSA) relapse (bNED), local failure, distant recurrence or death (whatever the cause).
    EFS time of patients living without any event at the end of the study will be censored on the last date a patient is known to be alive or lost to follow-up.
    EFS, calcolata come intervallo tra la randomizzazione e il primo evento di recidiva biochimica (PSA), locale, comparsa di metastasi a distanza o morte per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 MONTHS SINCE STUDY END
    3 MESI DALLA CHIUSURA DELLO STUDIO
    E.5.2Secondary end point(s)
    Overall survival (OS) will be measured from the date of randomization to the date of death (whatever the cause). Survival time of living patients will be censored on the last date a patient is known to be alive or lost to follow-up.
    Time to death due to prostate cancer will be measured from the date of randomization to the date of death caused by prostate cancer. Observation time of patients dead for causes other then prostate cancer, or living at the end of the study, will be censored on the last date a patient is known to be alive or lost to follow-up.
    Other efficacy endpoints
    Biochemical response rate (PSA Response), will be evaluated according to the PCWG2 Criteria.
    Safety (RTOG and NCI CTC Criteria).
    Biological end-points.
    OS calcolata dalla data della randomizzazione alla data della morte per qualsiasi causa.

    Sopravvivenza cancro – specifica calcolata dalla data della randomizzazione alla data di morte per tumore della prostata.

    Altri endpoints di efficacia: Sicurezza (Radiation Therapy Oncology Group [RTOG] e National Cancer Institute Common Terminology Criteria for Adverse Events [NCI - CTCAE]). Valutazione dei biomarkers. Nadir dei livelli di testosterone e valore medio durante il trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival (OS) will be measured from the date of randomization to the date of death (whatever the cause). Survival time of living patients will be censored on the last date a patient is known to be alive or lost to follow-up.
    Time to death due to prostate cancer will be measured from the date of randomization to the date of death caused by prostate cancer. Observation time of patients dead for causes other then prostate cancer, or living at the end of the study, will be censored on the last date a patient is known to be alive or lost to follow-up.
    Other efficacy endpoints
    Biochemical response rate (PSA Response), will be evaluated according to the PCWG2 Criteria.
    Safety (RTOG and NCI CTC Criteria).
    Biological end-points.
    OS calcolata dalla data della randomizzazione alla data della morte per qualsiasi causa.

    Sopravvivenza cancro – specifica calcolata dalla data della randomizzazione alla data di morte per tumore della prostata.

    Altri endpoints di efficacia: Sicurezza (Radiation Therapy Oncology Group [RTOG] e National Cancer Institute Common Terminology Criteria for Adverse Events [NCI - CTCAE]). Valutazione dei biomarkers. Nadir dei livelli di testosterone e valore medio durante il trattamento.
    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 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 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 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 Yes
    E.8.2.3.1Comparator description
    TRATTAMENTO INTEGRATO CON RADIOTERAPIA E TERAPIA DI DEPRIVAZIONE ANDROGENICA
    INTEGRATED TREATMENT WITH RADIOTHERAPY AND ANTIANDROGEN DEPRIVATION THERAPY
    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 concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    JULY 2017
    LUGLIO 2017
    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
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state172
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 172
    F.4.2.2In the whole clinical trial 172
    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)
    WILL BE EVALUATE FOR FOLLIWING TREATMENT AS STANDARD CARE
    IL PAZIENTE SARà VALUTATO PER ULTERIORI TERAPIE COME LO STANDARD CARE
    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 Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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