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    Summary
    EudraCT Number:2011-001076-18
    Sponsor's Protocol Code Number:26481585LYM2001
    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:2012-02-27
    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 number2011-001076-18
    A.3Full title of the trial
    A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
    Uno studio multicentrico, in aperto, a braccio singolo, di fase 2 sull`inibitore dell`istone deacetilasi (HDACi) JNJ-26481585, nei soggetti con linfoma cutaneo a cellule T di stadio Ib-IVa precedentemente trattato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Histone Deacetylase Inhibitor JNJ-26481585 in Previously Treated Patients with Stage Ib-IVa Cutaneous T-cell Lymphoma
    Uno studio dell'inibitore dell'istone deacetilasi JNJ-26481585 in pazienti gia' trattati con limfoma a cellule T della pelle di stadio Ib-IVa
    A.4.1Sponsor's protocol code number26481585LYM2001
    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 AddressArchimdesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+ 31(0)715242166
    B.5.5Fax number+ 31(0)715242110
    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 nameJNJ-26481585
    D.3.2Product code NA
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeJNJ-26481585
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 nameJNJ-26481585
    D.3.2Product code NA
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeJNJ-26481585
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    previously treated stage Ib-IVa Cutaneous T-cell Lymphoma
    Linfoma cutaneo precedentemente trattato a cellule T di stadio Ib-IVa
    E.1.1.1Medical condition in easily understood language
    Skin T cell lymphoma (a type of cancer of the immune system)
    Linfoma della pelle a cellule T (un tipo di cancro del sistema immunitario)
    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 10051708
    E.1.2Term Lymphoma cutis
    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 the overall cutaneous response rate (RR) based on the modified Severity Weighted Assessment Tool (mSWAT) criteria.
    L`obiettivo primario e' quello di determinare il tasso di riposta cutanea generale (RR) sulla base dei criteri del tool di valutazione ponderata della gravita' modificato (Severity Weighted Assessment Tool, mSWAT).
    E.2.2Secondary objectives of the trial
    * To determine the overall global RR based on consensus global response score for mycosis fungoides (MF) / Se'zary Syndrome (SS) (mSWAT + nodes/viscera + blood) * To evaluate the safety profile of JNJ-26481585 * To determine the duration of response (DOR) * To estimate progression free survival (PFS) * To estimate 1-year overall survival (OS)rate * To explore the effect of JNJ-26481585 on symptoms and capacity to function [patient reported outcomes (PROs)] * To assess pharmacodynamic markers of JNJ-26481585 activity in tumor biopsies and surrogate tissues * To explore biomarkers predictive of response to JNJ-26481585 * To explore the population PK of JNJ-26481585
    • Determinare l`RR globale generale sulla base del punteggio di riposta globale sul consenso per micosi fungoide (MF) / sindrome di Se'zary (SS) (mSWAT + linfonodi/viscere + sangue) • Valutare il profilo di sicurezza di JNJ-26481585 • Determinare la durata della risposta (DOR) • Determinare la sopravvivenza senza progressione (PFS) • Stimare il tasso di sopravvivenza generale a 1 anno (OS)• Analizzare l`effetto di JNJ-26481585 sui sintomi e sulla funzionalita' corporea [risultati riferiti dai pazienti (PRO)] • Valutare i marcatori farmacodinamici dell`attivita' di JNJ-26481585 nelle biopsie dei tumori e nei tessuti surrogati • Analizzare i biomarcatori predittivi di risposta a JNJ-26481585 • Analizzare la farmacocinetica della popolazione di JNJ-26481585
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place 2. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2 3. Histopathologically confirmed CTCL, either mycosis fungoides or Se'zary syndrome Stage Ib-IVa 4. Relapsed or refractory disease following at least 1 prior systemic XML File Identifier: yRzLWZHEasNV085BKFawfkXRQgc= Page 10/26 therapy for CTCL. PUVA is considered skin-directed therapy and not systemic therapy. Subjects must have recovered from toxicity related to prior systemic therapy after at least 2 weeks wash-out period. 5. Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days 6. Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) ≥ 1 cm in the longest diameter 7. Adequate liver function as determined by serum total bilirubin levels ≤ 1.5 x upper limit of normal (ULN), and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤2.5 x ULN 8. Adequate bone marrow function, as determined by an absolute neutrophil count (ANC)≥1200/mm3 (or ≥1.2x10 to the 9th/L); a platelet count ≥100,000/mm3 (or ≥100x10 to the 9th/L) and a hemoglobin level greater than 9 g/dL (or≥90 g/L), in the absence of transfusion requirements or cytokine support for 7 days prior to enrolling on the study 9. Serum potassium, calcium (corrected for albumin level), magnesium must be within institutional normal limits. Electrolyte supplementation is recommended to mantain electrolyte levels toward the high end of the normal limits. 10. LVEF within institutional normal limits, as determined by MUGA or echocardiography 11. Adequate renal function as determined by serum creatinine levels ≤ 1.5xULN 12. If a woman, before study entry she must be * postmenopausal (> 45 years of age with amenorrhea for at least 18 months) * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy) * if heterosexually active, practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization) before enrollment, throughout the study, and up to 6 months after stopping study drug 13. Negative pregnancy test (urine or serum β-hCG) at Screening (applicable to women of child bearing potential who are sexually active) at most 7 days prior to starting treatment 14. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 6 months after receiving the last dose of study drug 15. Subjects must have signed an informed consent document indicating that they understand the purpose and procedures required, and are willing to participate in the study 16. To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study
    1. Eta' di almeno 18 anni oppure maggiore eta' legale secondo la giurisdizione del paese in cui si svolge lo studio. 2. Stato di prestazione ECOG (Eastern Cooperative Oncology Group) da 0 a 2 (Allegato 1). 3. CTCL con conferma istopatologica, in forma di micosi fungoide o sindrome Se'zary di stadio Ib-IVa (Allegato 2). 4. Malattia resistente o refrattaria, che segue ad almeno 1 terapia sistemica precedente per CTCL. PUVA e' considerata una terapia per la pelle, non sistemica. I soggetti devono essersi ripresi dalla tossicita' correlata alla terapia sistemica precedente dopo un periodo di sospensione di almeno 2 settimane. 5. Regime anti-prurito stabile (corticosteroidi o antistaminici a uso topico) nei 28 giorni precedenti. 6. Malattia misurabile con almeno 1 lesione cutanea (cerotto, placca o tumore) con diametro massimo ≥ 1 cm. 7. Funzione epatica adeguata, definita tramite livelli di bilirubina sierica totale ≤1,5 volte il limite superiore della norma e livelli di alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) ≤2,5 volte il limite superiore della norma. 8. Funzione del midollo osseo adeguata, come stabilito tramite conteggio assoluto dei neutrofili (ANC) ≥1200/mm3 (o ≥1.2x109/L), conta piastrinica ≥100,000/mm3 (o ≥100x109/L) e livello di emoglobina superiore a 9 g/dL (o≥90 g/L), in assenza di necessita' di trasfusioni o supporto con citokina nei 7 giorni precedenti l`arruolamento nello studio. 9. Il valore sierico di potassio, calcio (corretto per livello di albumina) e magnesio deve essere nella norma. L`integrazione con elettroliti e' raccomandato per mantenere i livelli di elettroliti entro il limite superiore nella norma. 10. LVEF nella norma, come determinato tramite MUGA o ecocardiografia. 11. Funzione renale adeguata, come determinato da livelli sierici di creatinina ≤1,5 volte il limite superiore della norma. 12. I soggetti di sesso femminile prima dell`ingresso nello studio devono essere in post-menopausa (eta' &gt; 45 anni con amenorrea da almeno 18 mesi) essere state sottoposte a sterilizzazione chirurgica (donne sottoposte a isterectomia o ooforectomia bilaterale, legatura delle tube o non considerate fertili) se eterosessualmente attive, utilizzare un metodo contraccettivo efficace (ad es. contraccettivi orali con obbligo di prescrizione, iniezioni contraccettive, cerotto contraccettivo, dispositivo intrauterino, metodo a doppia barriera, sterilizzazione del partner maschile) prima dell’ arruolamento, nel corso dello studio stesso e nei 6 mesi successivi all`interruzione del farmaco sperimentale 13. Test di gravidanza negativo (BETA hCG in siero o urina) allo screening (per donne potenzialmente fertili e sessualmente attive) e al piu' tardi 7 giorni prima dell`inizio del trattamento. 14. Gli uomini devono essere d’accordo sull’uso di metodi contraccettivi a doppia barriera e non devono donare lo sperma durante lo studio e per i 6 mesi successivi all`ultima dose del farmaco dello studio. 15. I soggetti devono aver firmato un modulo di consenso informato indicante che hanno compreso lo scopo e le procedure e che intendono prendere parte allo studio. 16. Per partecipare alla parte di farmacogenomica facoltativa di questo studio, i soggetti devono aver firmato il modulo di consenso informato per la ricerca di farmacogenomica indicante che intendono prendervi parte (ove consentito dalla legislazione locale). 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 histone-deacetylase inhibitor therapy for CTCL 2. Concurrent systemic corticosteroid dose > 10 mg/day of prednisone or equivalent (stable use of ≤10 mg/day of prednisone for ≥1 month before study entry is allowed) 3. Major surgery or radiotherapy within 3 weeks before study drug administration. Focal radiotherapy for local disease control is allowed. Subjects must have recovered from prior radiotherapy or surgery related toxicity 4. Other malignancy within past 5 years. Exceptions include: basal or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Fe'de'ration Internationale de Gyne'cologie et d`Obste'trique Stage 1 carcinoma of the cervix, prostate intraepithelial neoplasia and biochemical relapse free ≥ 3 years 5. Unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure New York Heart Association Class II-IV; known presence of dilated, hypertrophic, or restrictive cardiomyopathy; or any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the subject at an unacceptably increased risk with study drug 6. History of any of the following: sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, atrial fibrillation, cardiac arrest, Mobitz II second degree heart block, or third degree heart block; QTc at Screening > 450 ms in males / > 470 ms in females; family history of short QT syndrome, long QT syndrome; obligate use of a cardiac pacemaker. Use of medications that may cause Torsades de Pointes; any of these medications must be discontinued for at least 5 half-lives prior to the first dose of JNJ-26481585. 7. Use of potent inhibitors of CYP3A4/A5 8. Known HIV/AIDS 9. Uncontrolled concurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing clinically significant active infection requiring systemic antibiotics, or psychiatric illness/social situation that may potentially impair subject`s compliance with study procedures 10. Planned major surgery during study period 11. Inadequate gastrointestinal absorption status (status postgastrectomy, upper gastrointestinal tract obstruction, inability to swallow) 12. Requires hematopoietic growth factors or transfusion of blood products to meet eligibility criteria 13. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study, or prevent the subject from meeting or performing study requirements 14. Pregnant or breast-feeding.
    1. Precedente terapia con inibitore dell`istone deacetilasi per CTCL. 2. Dose concomitante di corticosteroidi sistemici &gt; 10 mg/giorno di prednisone o equivalente (l`uso stabile di ≤10 mg/giorno di prednisone per ≥ 1mesi prima dell`ingresso nello studio e' consentito). 3. Intervento chirurgico importante o radioterapia nelle 3 settimane precedenti la somministrazione del farmaco sperimentale. La radioterapia focale per il controllo di una patologia locale e' consentita. I soggetti devono essersi ripresi dalla tossicita' correlata a radioterapia o intervento chirurgico precedente. 4. Altro tumore maligno nei 5 anni precedenti. Fanno eccezione: carcinoma cutaneo a cellule basali o squamose non metastatico, carcinoma della cervice in situ o carcinoma della cervice di stadio 1 secondo la definizione della Fe'de'ration Internationale de Gyne'cologie et d’Obste'trique, neoplasia intraepiteliale della prostata e assenza di recidive confermata da analisi biochimiche ≥ 3 anni. 5. Angina instabile o infarto miocardico nei 12 mesi precedenti; insufficienza cardiaca congestizia di classe II-IV secondo i criteri di New York Heart Association (vedere Allegato 4); presenza nota di cardiomiopatia dilatata, ipertrofica o restrittiva; oppure qualsiasi altra anomalia cardiaca che, secondo lo sperimentatore, il monitor medico o il consulente cardiologo, puo' comportare rischi inaccettabili per il paziente in combinazione con il farmaco sperimentale. 6. Storia di uno degli eventi riportati di seguito: tachicardia ventricolare sostenuta, fibrillazione ventricolare, torsades de pointes, fibrillazione atriale, arresto cardiaco, blocco cardiaco di secondo grado di tipo Mobitz II oppure blocco cardiaco di terzo grado; QTc allo screening &gt; 450 ms nei soggetti maschili / &gt; 470 ms nei soggetti femminili; storia familiare di sindrome QT corto, sindrome QT lungo; uso obbligatorio di pacemaker cardiaco. Uso di farmaci in grado di causare torsades de pointes (Allegato 5); l`assunzione di farmaci di questo tipo deve essere stata interrotta da almeno 5 emivite prima del primo dosaggio di JNJ-26481585. 7. Uso di inibitori potenti di CYP3A4/A5 (vedere Sezione 8.1) 8. Condizione di HIV/AIDS nota. 9. Malattia concomitante non controllata, comprese, pur senza limitazione, ipertensione o diabete non ben controllati, infezione attiva clinicamente significativa in corso, che richiede antibiotici sistemici oppure malattia psichiatrica/situazione sociale potenzialmente in grado di pregiudicare la conformita' del soggetto con le procedure dello studio. 10. Intervento chirurgico importante in programma nel periodo dello studio. 11. Stato di assorbimento gastrointestinale inadeguato (stato di post-gastrectomia, ostruzione del tratto gastrointestinale superiore, incapacita' di ingerire). 12. Necessita' di fattori di crescita ematopoietici o di trasfusione di prodotti ematici per soddisfare i criteri di idoneita'. 13. Qualsiasi condizione che, secondo il giudizio dello sperimentatore, comprometterebbe il benessere del soggetto o lo studio o che impedirebbe al soggetto di corrispondere o adempiere ai requisiti dello studio. 14. Gravidanza o allattamento al seno.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the overall cutaneous RR (as determined by mSWAT criteria), defined as the proportion of evaluable subjects who achieve a CR (complete disappearance of all cutaneous disease) or PR (≥ 50% reduction in mSWAT score compared to baseline).
    End point primario: tasso di risposta cutanea generale (determinato da criteri di mSWAT) definito come proporzione di soggetti valutabili che raggiungono una risposta cutanea completa oppure una risposta parziale (riduzione di almeno 50% nel punteggio mSWEAT in confronto alla baseline)
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 6 weeks
    ogni 6 settimane
    E.5.2Secondary end point(s)
    Overall global RR, defined as the proportion of subjects who achieve CR or PR based on the consensus global response score for MF/SS [defined as the total score of tumor, lymph nodes, metastasis, blood (TNMB) staging, ie, cutaneous disease, lymph nodes, viscera and blood] * PFS, defined as the interval between the date of randomization and the date of disease progression or death from any cause, whichever occurs first
    Il tasso di risposta globale generale definito come la proporzione di soggetti che conseguono la risposta completa o la risposta parziale sul punteggio di risposta globale sul consenso per micosi fungoidee e sindrome di Sezary (definito come il punteggio totale della stadiazione del tumore, linfonodi, metastasi e sangue, per esempio malattia cutanea, linfonodi, viscere e sangue), sopravvivenza senza progressione definita come l’intervallo tra la data di randomizzazione e la data della progressione della malattia o morte per qualsiasi causa qualunque cosa accade prima.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 12 weeks
    ogni 12 settimane
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory Biomarkers Evaluations
    Valutazione dei biomarcatori esplorativi
    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 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 Yes
    E.8.2.3.1Comparator description
    A braccio singolo
    Single-arm
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    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
    The Study is considered completed with the last study assessment for the last subject participating in the study.
    Lo studio si considera concluso con l'ultima valutazione dello studio per l'ultimo paziente arruolato
    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 months0
    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 months0
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 23
    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 may enter a Long-term Extension Phase and continue to receive study treatment until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective drugs that the subject may receive, or treating physician advice). The Long-term Extension Phase will continue for a maximum of 2 years beyond the clinical cut-off for primary analysis.
    I pazienti possono entrare in una fase di estensione a lungo termine e continuare a ricevere il trattamento in studio fino al versificarsi di una ragione di discontinuazione (progressione della malattia, tossicita', disponibilita' di altri farmaci efficaci che il paziente potrebbe assumere o per decisione del medico dello studio). La fase di estensione a lungo termine durera' al massimo per 2 anni oltre il cut-off clinico dell`analisi primaria
    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 Decision2011-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-22
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