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    Summary
    EudraCT Number:2015-000194-12
    Sponsor's Protocol Code Number:QUASAR-2014-001
    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:2016-10-18
    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 number2015-000194-12
    A.3Full title of the trial
    Isoquercetin as an adjunct therapy in patients with kidney cancer receiving first-line sunitinib: a phase I/II trial
    Isoquercetina come terapia di supporto nei pazienti affetti da tumore del rene in trattamento di I linea con sunitinib: uno studio di fase I/II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Isoquercetina come terapia di supporto nei pazienti affetti da tumore del rene in trattamento di I linea con sunitinib: uno studio di fase I/II
    Isoquercetin as an adjunct therapy in patients with kidney cancer receiving first-line sunitinib: a phase I/II trial
    A.3.2Name or abbreviated title of the trial where available
    QUASAR
    QUASAR
    A.4.1Sponsor's protocol code numberQUASAR-2014-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02446795
    A.5.4Other Identifiers
    Name:QUASARNumber:QUASAR - 2014 - 001
    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 SponsorCONSORZIO ONCOTECH
    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 supportAzienda Farmaceutica: Quercegen Pharma LLC - Stati Uniti d'America
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo traversa migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailhelpdesk.quasar@oncotech.org
    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 nameIQC-950AN
    D.3.2Product code Isoquercetin
    D.3.4Pharmaceutical form Capsule, soft
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced or metastatic renal cell carcinoma of any histology (equivalent to Stage IV RCC according to AJCC staging)
    Tumore renale localmente avanzato (definita come malattia non suscettibile di chirurgia curativa o radioterapia) o metastatico
    E.1.1.1Medical condition in easily understood language
    Locally advanced or metastatic renal cell carcinoma of any histology (equivalent to Stage IV RCC according to AJCC staging)
    Tumore renale localmente avanzato (definita come malattia non suscettibile di chirurgia curativa o radioterapia) o metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10061482
    E.1.2Term Renal neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10038389
    E.1.2Term Renal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10050018
    E.1.2Term Renal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    To evaluate the safety of concomitant oral administration of isoquercetin consumed at two dose levels of 450 and 900 mg daily, respectively, and administered in combination with sunitinib given according to the schedule preferred by the investigator (at least 14 days of sunitinib continuous daily administration is required).
    The primary objective of the phase II part of this study is to evaluate the effect on fatigue of isoquercetin administered at the maximum tolerated dose, by using the FACT-F questionnaire in patients with kidney cancer receiving first-line sunitinib. The anti-fatigue effect of isoquercetin will be measured as difference of the mean variation of the FACT-F score obtained in patients receiving sunitinib plus isoquercetin vs placebo.

    L’obiettivo primario della fase I è quello di valutare la sicurezza della somministrazione orale di isoquercetina, un flavonolo naturalmente presente in alimenti di origine vegetale, a due livelli di dose (450 mg e 900 mg) in concomitanza con sunitinib somministrato secondo la schedula scelta dallo sperimentatore (tale schedula deve prevedere almeno 14 giorni di sunitinib).
    L'obiettivo primario di questo studio è quello di valutare l'effetto dell’isoquercetina somministrata oralmente alla dose giornaliera stabilita nella fase I sulla fatigue in pazienti con cancro del rene in trattamento di prima linea con sunitinib, misurato attraverso il questionario FACT-F. L'effetto anti-fatigue dell’isoquercetina sarà misurato come differenza della variazione media del punteggio FACT-F ottenuto nei pazienti trattati con sunitinib in associazione a isoquercetina confrontato con placebo.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are:
    - to evaluate the effect of isoquercetin vs. placebo on quality of life as assessed by the FACT-G score
    - to evaluate the effect of the treatment on serum markers of inflammation (sedimentation rate, C reactive protein, cytokines)
    - to evaluate the effect of isoquercetin vs. placebo on sunitinib dose density and patient compliance
    - to evaluate the safety and tolerability of the treatment (including AEs, SAEs, withdrawal of treatment due to AE, vital signs, ECG and clinical laboratory)
    - to evaluate the effect of isoquercetin vs. placebo on muscle density using CT scans performed to evaluate response to treatment
    - to evaluate the effect of isoquercetin vs. placebo on the incidence of symptomatic and asymptomatic deep venous thrombosis
    Gli obiettivi secondari dello studio sono:
    -Valutare l'effetto dell’isoquercetina confrontato con placebo sulla qualità della vita, attraverso il questionario FACT-G;
    -Valutare l'effetto di sunitinib isoquercetina confrontato con sunitinib e placebo sui marcatori sierici di infiammazione (VES, proteina C reattiva, citochine)
    -Valutare l'effetto di isoquercetina confrontato con placebo sulla densità della dose di sunitinib e la compliance del paziente in trattamento con sunitinib
    -Valutare la sicurezza e la tollerabilità di sunitinib associato a isoquercetina vs sunitinib associato a placebo (compresi eventi avversi, eventi avversi gravi, l’interruzione del trattamento a causa di AE, segni vitali, ECG e laboratorio clinico).
    -Valutare l'effetto di isoquercetina confrontato con placebo sulla densità muscolare TAC effettuata per valutare la risposta al trattamento
    -Valutare l'effetto di isoquercetina confrontato con placebo sull'incidenza della trombosi venosa profonda sintomatica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Received no prior systemic therapy other than sunitinib (including interleukin-2,
    interferon-α, chemotherapy, bevacizumab, mTOR inhibitor sorafenib or other VEGF
    TKI) for advanced or metastatic RCC. Patients who received adjuvant treatment with
    a cancer vaccine are eligible;
    2. Patients with locally advanced (defined as disease not amenable to curative surgery or
    radiation therapy) or metastatic renal cell carcinoma of any histology (equivalent to
    Stage IV RCC according to AJCC staging) for whom treatment with sunitinib is either
    planned or ongoing. Patients with non-measurable disease are allowed if metastatic
    disease can be confirmed;
    3. Patients for whom treatment with sunitinib is planned must have had a whole body
    CT scan within 30 days prior to enrollment; patients who are already being treated
    with sunitinib at the time of enrollment must have had a whole body CT scan showing
    non progressive disease according to the RECIST criteria with respect to the
    assessment performed at sunitinib initiation within 30 days of enrollment;
    4. ECOG PS of 0 or 1;
    5. Age ≥18 years;
    6. A female is eligible to enter and participate in this study if she is non-childbearing
    potential (i.e. physiologically incapable of becoming pregnant).
    The need for a screening pregnancy test depends on whether a female subject is of
    childbearing potential or non-childbearing potential.
    7. A female of non-childbearing potential (i.e., physiologically incapable of becoming
    pregnant) is defined as any female who has had a hysterectomy, bilateral ophorectomy
    (ovariectomy) or bilateral tubal ligation, or is post-menopausal by NCCN
    criteria.Adequate organ system functions;
    8. Total serum calcium concentration <12.0mg/dL;
    9. Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN)
    as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan.
    The same modality used at baseline must be applied for subsequent evaluations;
    10. Patient is able to swallow and retain oral tablets;
    11. Written informed consent obtained before any screening procedure and according to
    local guidelines.
    Nessuna terapia sistemica precedente ad eccezione del sunitinib (compresa l'interleuchina-2, l'interferone-α, chemioterapia, bevacizumab, inibitore di mTOR, sorafenib o altro VEGF TKI) per RCC avanzato o metastatico. I pazienti che hanno ricevuto un trattamento adiuvante immunoterapico possono essere inclusi;
    2. Pazienti affetti da carcinoma localmente avanzato (definito come malattia non suscettibili di intervento chirurgico curativo o radioterapia) o metastatico delle cellule renali di qualsiasi istologia (equivalente a Stadio IV RCC secondo AJCC staging), per i quali il trattamento con sunitinib è previsto o in corso. I pazienti con malattia non misurabile sono ammessi che la malattia metastatica confermata.
    3. I pazienti per i quali il trattamento con sunitinib è previsto devono presentare CT scan del intero corpo entro 30 giorni precedenti l'arruolamento; pazienti già in trattamento con sunitinib al momento dell'iscrizione devono aver avuto una CT scan dell’ intero che mostra malattia non progressiva in base ai criteri RECIST rispetto alla valutazione effettuata a inizio sunitinib entro 30 giorni dall’arruolamento.
    4. ECOG PS di 0 o 1;
    5. Età ≥18 anni;
    6. Una paziente di sesso femminile può partecipare a questo studio se potenzialmente non fertile (fisiologicamente incapace di rimanere incinta).
    La necessità di un test di gravidanza dipende dal fatto che un soggetto femminile sia potenzialmente in età fertile o non fertile.
    Una paziente potenzialmente non fertile (vale a dire, fisiologicamente incapace di rimanere incinta) è definita come qualsiasi donna che ha avuto un intervento di isterectomia, ovariectomia bilaterale (ovariectomia) o di legatura delle tube bilaterale, o è in post-menopausa in accordo ai criteri NCCN.
    7. Adeguate funzionalità d'organo (cuore, polmoni, fegato, rene);
    8. Concentrazione totale di calcio nel siero <12.0 mg / dL;
    9. Frazione di eiezione ventricolare sinistra (FEVS) ≥ limite inferiore istituzionale normale (LLN) valutata mediante ecocardiografia (ECHO) o acquisizione porte multiple (MUGA) scan. La stessa modalità utilizzata al basale deve essere applicato per le valutazioni successive;
    10. Il paziente è in grado di deglutire compresse/capsule orali;
    11. Consenso informato scritto ottenuto prima di qualsiasi procedura di screening e secondo le linee guida locali.
    E.4Principal exclusion criteria

    1. History of another malignancy;
    2. History or clinical evidence of central nervous system (CNS) metastases;
    3. Any clinically significant gastrointestinal abnormalities that may increase the risk for
    gastrointestinal bleeding or affect absorption of investigational product;
    4. Unable to tolerate continuous daily administration of 50 mg sunitinib
    5. Presence of uncontrolled infection;
    6. Serum potassium < lower normal limits;
    7. Corrected QT interval (QTc) >480 msec using Bazett’s formula;
    8. History of one or more of the following cardiovascular conditions within the past 6
    months:
     Cardiac angioplasty or stenting;
     Myocardial infarction;
     Unstable angina;
     Coronary artery bypass graft surgery;
     Symptomatic peripheral vascular disease;
     Class III or IV congestive heart failure, as defined by the New York Heart
    Association (NYHA);
    9. Poorly controlled hypertension (defined as systolic blood pressure (SBP) of >
    150mmHg or diastolic blood pressure (DBP) of > 90mmHg) at baseline;
    10. History of cerebrovascular accident (CVA) including transient ischemic attack (TIA),
    pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6
    months;
    11. Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
    presence of any non-healing wound, fracture, or ulcer (procedures such as catheter
    placement not considered to be major);
    12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels;
    13. Evidence of active bleeding or bleeding diathesis;
    14. Significant hemoptysis within 6 weeks prior to first dose of study drug;
    15. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that
    could interfere with patient’s safety, obtaining informed consent or compliance to the
    study;
    16. Use any prohibited medications within 14 days of the first dose of study medication;
    17. Use of an investigational agent other than sunitinib, including an investigational anticancer
    agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose
    of study drug;
    18. Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose
    of study treatment;
    19. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
    chemically related to sunitinib;
    20. Clinically significant depression (PHQ-9 score >15), anxiety (GAD score >10),
    clinically significant insomnia (positivity of ISQ).
    1. Anamnesi di un altro tumore maligno;
    2. Anamnesi o evidenza clinica di metastasi al sistema nervoso centrale (SNC);
    3. Qualsiasi alterazione gastrointestinale che possa aumentare il rischio di sanguinamento gastrointestinale o influenzare l'assorbimento del prodotto sperimentale;
    4. Qualsiasi infezione non controllata;
    5. Incapacità di tollerare una dose continuativa giornaliera di 50 mg sunitinib;
    6. Livelli sierici di potassio inferiori ai limiti normali;
    7. Intervallo QT corretto (QTc)> 480 msec usando la formula di Bazett;
    8. Storia di una o più delle seguenti condizioni cardiovascolari all'interno ultimi 6 mesi:
     angioplastica cardiaca o stenting;
     infarto del miocardio;
     angina instabile;
     arteria intervento di bypass coronarico;
     malattia vascolare periferica sintomatica;
     Classe III o IV insufficienza cardiaca congestizia, come definito dal New York Heart Association (NYHA).
    9. Ipertensione scarsamente controllata (definita come pressione arteriosa sistolica (SBP) di> 150mmHg o pressione arteriosa diastolica (DBP) di> 90 mmHg) al basale;
    10. Storia di incidente cerebrovascolare (CVA) compreso l'attacco ischemico transitorio (TIA), embolia polmonare trombosi venosa profonda (TVP) negli ultimi 6 mesi;
    11. Chirurgia maggiore o traumi nei 28 giorni precedenti alla prima dose del farmaco in studio e / o la presenza di eventuali ferite non guarite, fratture, o ulcera (procedure, come il posizionamento del catetere non ritenuta grave);
    12. Lesioni endobronchiali note e / o lesioni infiltranti grandi vasi polmonari;
    13. Diatesi emorragica;
    14. Emottisi significativa entro 6 settimane prima della prima dose del farmaco in studio;
    15. Qualsiasi patologia grave e / o instabile preesistente di tipo psichiatrico, o altre condizioni che potrebbero interferire con la sicurezza del paziente, o la sua compliance allo studio;
    16. L’uso di qualunque medicazione proibita nei 14 giorni precedenti l’arruolamento;
    17. L'uso di un farmaco sperimentale, tra cui un agente anti-neoplastico in fase di sperimentazione, entro 28 giorni o 5 emivite, a seconda di quale dei due intervalli sia il più lungo, prima della prima dose del farmaco in studio.
    18. Radioterapia, chirurgia o tumore embolizzazione entro 14 giorni prima della prima dose del trattamento in studio;
    19. Nota reazione di ipersensibilità immediata o ritardata o idiosincrasia al sunitinib, all’isoquercetina o a farmaci chimicamente connessi;
    20. Depressione clinicamente significativa (PHQ-9 punteggio> 15), ansia (GAD punteggio> 10), insonnia clinicamente significativa (positività di ISQ).
    E.5 End points
    E.5.1Primary end point(s)
    The maximum tolerated dose (450/900 mg daily) of isoquercetin
    Dose Massima Tollerata di isoquercetina
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I 6 months
    Fase I: 6 mesi
    E.5.2Secondary end point(s)
    Fatigue as assessed by FACIT-Fatigue
    Fatigue as assessed by FACIT-Fatigue
    Quality of life as assessed by FACT-G score
    Incidence and severity of adverse events
    Changes from baseline of muscle index as measured on CT scan performed for radiological response
    Incidence of deep venous thrombosis, as assessed by doppler ultrasound
    Variation in serum markers of inflammation
    Stato di Fatigue del paziente valutato tramite il FACT-F
    Stato di Fatigue del paziente valutato tramite il FACT-F
    Qualità della vita valutato tramite il FACT-G
    Incidenza e severita degli eventi avversi
    Effetto di isoquercetina confrontato con placebo sulla densità muscolare TAC effettuata per valutare la risposta al trattamento
    Effetto di isoquercetina confrontato con placebo sull'incidenza della trombosi venosa profonda sintomatica e asintomatica
    Valutare l'effetto di sunitinib isoquercetina confrontato con sunitinib e placebo sui marcatori sierici di infiammazione (VES, proteina C reattiva, citochine)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase II 12 months
    Phase II 6 months
    Phase II 12 months
    During the study : 18 months
    During the study : 18 months
    During the study : 18 months
    During the study : 18 months
    Fase II 12 mesi
    Fase II 6 mesi
    Fase II 12 mesi
    Durante lo studio : 18 mesi
    Durante lo studio : 18 mesi
    Durante lo studio : 18 mesi
    Durante lo studio : 18 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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Nella fase I dello studio QUASAR due livelli di dosaggio di isoquercetina (450 e 900 mg) verranno st
    In the phase I part of the QUASAR trial, two dose levels of isoquercetin (450 and 900 mg) will be ex
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 trial5
    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 concerned5
    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
    LPLV after 56 days sunitinib treatment
    LPLV dopo 56 giorni di trattamento con sunitinib
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.1.1In 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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    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)
    Treatment Plans or care for subject has ended his/her partecipation in the trial will follow clinical practice
    I programmi di trattamento e di assistenza per i soggetti al termine della partecipazione allo studio seguono la normale pratica clinica
    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 Decision2016-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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