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    Summary
    EudraCT Number:2014-003798-41
    Sponsor's Protocol Code Number:GIM18-FUMANCE
    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:2016-10-19
    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 number2014-003798-41
    A.3Full title of the trial
    Randomized phase III study of fulvestrant as maintenance therapy after first-line chemotherapy in HER2 negative postmenopausal metastatic breast cancer patients
    Studio randomizzato di fase III di Fulvestrant come terapia di mantenimento dopo la I linea chemioterapica in pazienti in post-menopausa HER2-negativo con tumore della mammella avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized phase III study of fulvestrant as maintenance therapy after first-line chemotherapy in HER2 negative postmenopausal metastatic breast cancer patients
    Studio randomizzato di fase III di Fulvestrant come terapia di mantenimento dopo la I linea chemioterapica in pazienti in post-menopausa HER2-negativo con tumore della mammella avanzato
    A.3.2Name or abbreviated title of the trial where available
    GIM18-FUMANCE
    GIM18-FUMANCE
    A.4.1Sponsor's protocol code numberGIM18-FUMANCE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02383030
    A.5.4Other Identifiers
    Name:GIM18-FUMANCENumber:GIM18-FUMANCE
    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: Astra Zeneca S.p.a. - Italia
    B.4.2CountryItaly
    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 pointClinical Research Organization
    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.fumance@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 Yes
    D.2.1.1.1Trade name FASLODEX - 250MG/5ML SOLUZIONE INIETTABILE - USO INTRAMUSCOLARE - SIRINGA PRERIEMPITA(VETRO) - 5 ML 2 SIRINGHE PRERIEMPITE + 2 AGHI DI SICUREZZA
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA UK LIMITED
    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 nameFaslodex
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePR1
    D.3.9.3Other descriptive nameFULVESTRANT
    D.3.9.4EV Substance CodeSUB13933MIG
    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.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
    Women with HR+, HER2- metastatic breast cancer
    Carcinoma mammario metastatico con recettori ormonali positivi ed HER2 negativo
    E.1.1.1Medical condition in easily understood language
    Women with HR+, HER2- metastatic breast cancer
    Carcinoma mammario metastatico con recettori ormonali positivi ed HER2 negativo
    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 LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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
    To compare the maintenance Fulvestrant versus no therapy with respect to Progression-Free Survival (time to the start of Fulvestrant treatment to the progression) for women with hormone receptor positive, HER2 negative metastatic breast cancer
    and in response or stability after first-line chemotherapy
    Confrontare la terapia di mantenimento con Fulvestrant vs nessuna terapia in termini di Sopravvivenza libera da progressione (tempo dall'inizio del trattamento fulvestrant per la progressione) in donne con carcinoma mammario metastatico con recettori ormonali positivi ed HER2 negativo in risposta o in stabilità dopo chemioterapia di prima linea
    E.2.2Secondary objectives of the trial
    To compare the maintenance Fulvestrant versus no therapy with respect to
    objective response rate [ORR] (complete response [CR] + partial response [PR]).
    • To compare the maintenance Fulvestrant versus no therapy with respect to
    duration of response (CR + PR).
    • To compare maintenance Fulvestrant versus no therapy with respect to disease
    control rate [DCR] (complete response [CR] + partial response [PR] + stable
    disease [SD]).
    • In order to capture possible negative effects on next-line therapy and to outbalance tolerability and toxicity concerns related to maintenance therapy, we plan to evaluate Progression Free Survival 2 (PFS2), the comparing between maintenance
    - Confrontare la terapia di mantenimento con Fulvestrant vs nessuna terapia in termini di tasso di risposta obiettiva [ORR] (risposta completa [CR] + risposta parziale [PR]).
    - Confrontare la terapia di mantenimento con Fulvestrant vs nessuna terapia in termini di durata della risposta (CR + PR).
    - Confrontare la terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto al tasso di controllo della malattia [DCR] (risposta completa [CR] + risposta parziale [PR] + malattia stabile [SD])
    - Confrontare una terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto al PFS2 misurato dalla randomizzazione alla seconda progressione.
    - Confrontare una terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto alla sopravvivenza globale [OS]
    - Valutare la sicurezza e la tollerabilità della terapia con Fulvestrant vs nessuna terapia
    - Confrontare una terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto alla QoL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically diagnosis of breast cancer;
    2. Presence of metastatic disease either measureable or non-measureable but evaluable bone
    disease as defined by the Response Evaluation Criteria in Solid Tumors (38);
    3. Diagnosis of hormone receptor positive (HR+), HER2 negative breast cancer. To fulfill the
    requirement for HR+ disease, a breast cancer must express, by immunohistochemistry
    (IHC), at least one of the hormone receptors (estrogen receptor [ER], progesterone receptor
    [PR]). To fulfill the requirement for HER2 negative disease, a breast cancer must not
    demonstrate over-expression of HER2 by either IHC or fluorescence in-situ hybridization
    (FISH);
    4. Post-menopausal status at the time of randomization.
    5. Previous treatment with either an antiestrogen or an aromatase inhibitor for adjuvant or metastatic disease
    is allowed;
    6. Age >18;
    One line chemotherapy for metastatic disease discontinued for 21-28 days. Patient has to
    have response or stability from the first-line chemotherapy. The patient may have received
    prior systemic chemotherapy in the neo-adjuvant or adjuvant setting;
    8. Patients with measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors
    (RECIST) criteria;
    9. Performance Status (ECOG) <2;
    10. No brain metastases;
    11. No clinically serious concurrent illnesses;
    12. Adequate organ function (obtained within 14 days prior to treatment study) as evidenced
    by:
    a) Absolute neutrophil count (ANC) 1.5 X 109/L without myeloid growth factor support
    for 7 days preceding the lab assessment;
    b) Haemoglobin (Hb) 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if hemoglobin is
    corrected to 9 g/dL (90 g/L) as assessed by the central laboratory by growth factor or
    transfusion prior to randomization;
    c) Platelet count 75 X 109/L without blood transfusions for 7 days preceding the lab
    assessment;
    d) Bilirubin 1.5 X upper limit of normal (ULN), except for patients with a documented
    history of Gilbert’s disease; Alanine aminotransferase (ALT), and aspartate
    aminotransferase (AST) 2.5 X ULN (for patients with liver metastases 5 X ULN);
    e) Alkaline phosphatase 3 X ULN (for patients with liver metastases, 5 X ULN);
    f) Serum creatinine 1.5 mg/dL (133 mol/L) or calculated creatinine clearance 50 mL/min
    (using Cockcroft-Gault formula)
    13. Use of bisphosphonates are allowed;
    14. Use of antiangiogenetic drugs (bevacizumab associated to paclitaxel) is allowed, but
    discontinued 21-28 days before start study;
    15. Life expectancy > 12 weeks;
    16. Are willing to participate for the duration of the study and to follow study procedures;
    17. Written informed consent prior to any study-specific procedures Written informed consent;
    1. Diagnosi istologica o citologica di cancro al seno;
    2. Presenza di malattia metastatica o misurabile o non misurabile ma con una valutabile malattia ossea come definito dai criteri di valutazione della risposta nei tumori solidi;
    3. Diagnosi di neoplasia mammaria recettori ormonali positivi (HR+), HER2 negativo. Per soddisfare il requisito di HR+, un tumore mammario deve esprimere, mediante immunoistochimica (IHC), almeno uno dei recettori ormonali (recettore per gli estrogeni [ER], il recettore del progesterone [PR]). Per soddisfare il requisito per la malattia HER2 negativo, un tumore mammario non deve dimostrare over-espressione di HER2 da IHC o da una fluorescenza in situ (FISH);
    4. Stato di post-menopausa al momento della randomizzazione.
    5. E consentito un precedente trattamento sia con antiestrogeni o inibitore delle aromatasi come adiuvante o per malattia metastatica.
    6. Età > 18;
    7. Una linea di chemioterapia per la malattia metastatica sospesa da 21-28 giorni. Dopo chemioterapia di prima linea il paziente dovrà aver ottenuto una risposta o stabilità della malattia. Il paziente può aver ricevuto una precedente chemioterapia sistemica nel setting neo-adiuvante o adiuvante;
    8. Pazienti con misurabile o valutabile malattia in base ai criteri del Response Evaluation Criteria in Solid Tumours (RECIST)
    9. Performance Status (ECOG) <2;
    10. Assenza di metastasi cerebrali;
    11. Assenza di gravi malattie concomitanti;
    12. Funzione d'organo adeguata (ottenuto nei 14 giorni precedenti al trattamento di studio), come evidenziato da:
    - Conta assoluta dei neutrofili (ANC) 1,5 x 109/l senza supporto del fattore di crescita mieloide nei 7 giorni precedenti la valutazione di laboratorio;
    - Emoglobina (Hb) 9 g/dL (90 g/L); <9 g/dl (<90 g/L) è accettabile se l'emoglobina viene corretta a 9 g / dl (90 g/L) attraverso fattore di crescita o trasfusione, prima della randomizzazione;
    - Conta piastrinica 75 X 109 / L senza trasfusioni di sangue per i 7 giorni precedenti la valutazione di laboratorio;
    - Bilirubina 1.5 volte il limite superiore della norma (ULN), fatta eccezione per i pazienti con una storia documentata di malattia di Gilbert; Alanina aminotransferasi (ALT), e aspartato
    aminotransferasi (AST) 2,5 x ULN (per i pazienti con metastasi epatiche 5 x ULN);
    - Fosfatasi alcalina 3 x ULN (per i pazienti con metastasi epatiche, 5 x ULN);
    - Creatinina sierica 1,5 mg/dl (133 mmol/l) o clearance della creatinina calcolata a 50 ml/min (usando la formula di Cockcroft-Gault)
    13. È ammesso l’uso di bifosfonati;
    14. L'uso di farmaci antiangiogenetici (bevacizumab associato a paclitaxel) è consentito ma interrotto 21-28 giorni prima dell'inizio di studio;
    15. Aspettativa di vita> 12 settimane;
    16. Il paziente ha voglia di partecipare allo studio per tutta la sua durata dello studio e di seguire le procedure correlate;
    17. Consenso informato scritto prima di qualsiasi procedura specifica
    E.4Principal exclusion criteria
    1. Treatment with a drug that has not received regulatory approval for any indication within
    21-28 days from the randomization;
    2. Drug (chemotherapy or biological drug) after the end of first-line chemotherapy for
    manteinance phase;
    3. Significant known cardiovascular impairment (NYHA CHF > grade 2, unstable angina,myocardial infarction within the previous 6 months prior to randomization, or existing
    serious cardiac arrhythmia). VECF (Ventricular Ejecion Cardiac Fraction) [ 50%;
    4. Prior malignancy (other than breast cancer) except for non-melanoma skin cancer and
    carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more
    than 5 years prior to randomization;
    5. Severe/uncontrolled intercurrent illness within the previous 28 days prior to randomization.
    6. Any other significant co-morbid conditions that in the opinion of the Investigator would
    impair study participation or cooperation;
    7. Patients with psychiatric illness, social situation or geographical situation that would
    preclude informed consent or limit compliance with study requirements, as determined by
    the Investigator;
    Trattamento con un farmaco che non ha ricevuto approvazione per nessun tipo di indicazione nei 21-28 giorni dalla randomizzazione;
    2. L’utilizzo di un farmaco (Chemioterapico o biologico) per la fase di mantenimento dopo la fine della prima linea di chemioterapia;
    3. Insufficienza cardiovascolare (NYHA CHF > grado 2, angina instabile, infarto miocardico nei precedenti 6 mesi prima della randomizzazione, o esistente grave aritmia cardiaca). VECF (Ejecion Cardiac Fraction ventricolare) ≤ 50%;
    4. Diagnosi di precedente neoplasia maligna primitiva (diverso da cancro al seno), eccetto per il cancro non-melanoma della pelle e carcinoma in situ (della cervice della vescica), a meno che siano stati diagnosticati e trattati in via definitiva più di 5 anni prima della randomizzazione;
    5. Severa/ incontrollata malattia intercorrente nei 28 giorni precedenti la randomizzazione;
    6. Eventuali altre significative condizioni di co-morbidità che a giudizio dello sperimentatore potrebbe pregiudicare la partecipazione allo studio o di cooperazione;
    7. Pazienti con malattia psichiatrica, situazione sociale o situazione geografica che impediscono il consenso o la conformità con i requisiti dello studio, come determinato dallo sperimentatore;
    E.5 End points
    E.5.1Primary end point(s)
    The endpoint is maintenance-progression-free survival (mPFS) defined as the time between the date of randomization and the date of progression or death, whichever occurs first. A subject who dies without reported progression will be considered to have progressed on the date of death. For those subjects who remain alive and have not progressed, mPFS will be censored on the date of last evaluable tumor assessment.
    L'endpoint è maintenance-progression-free survival (mPFS),
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint is defined as the time between the date of randomization and the date of progression or death, whichever occurs first. A subject who dies without reported progression will be considered to have progressed on the date of death.
    L'endpoint è definito come il tempo tra la data di randomizzazione e la data di progressione o morte, a seconda di quale si verifichi prima. Un soggetto dichiarato deceduto senza riferita progressione sarà considerata progredito alla data del decesso
    E.5.2Secondary end point(s)
    To compare maintenance Fulvestrant versus no therapy with respect to overall survival [OS]
    To characterize the safety and tolerability the maintenance Fulvestrant versus no therapy
    To compare maintenance Fulvestrant versus no therapy with respect to QoL
    • In order to capture possible negative effects on next-line therapy and to outbalance tolerability and toxicity concerns related to maintenance therapy, we plan to evaluate Progression Free Survival 2 (PFS2), the comparing between maintenance Fulvestrant versus no therapy measured from randomization to second progression (progression of second-line treatment after progression of maintenance treatment.
    PFS2
    PFS2
    Confrontare la terapia di mantenimento con Fulvestrant vs nessuna terapia in termini di tasso di risposta obiettiva [ORR] (risposta completa [CR] + risposta parziale [PR]).
    Confrontare la terapia di mantenimento con Fulvestrant vs nessuna terapia in termini di durata della risposta (CR + PR).
    Confrontare la terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto al tasso di controllo della malattia [DCR] (risposta completa [CR] + risposta parziale [PR] + malattia stabile [SD]).
    Confrontare una terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto alla sopravvivenza globale [OS]
    Valutare la sicurezza e la tollerabilità della terapia con Fulvestrant vs nessuna terapia
    Confrontare una terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto alla QoL
    Confrontare una terapia di mantenimento con Fulvestrant vs nessuna terapia rispetto al PFS2 misurato dalla randomizzazione alla seconda progressione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time between the date of randomization and the date of progression or death, whichever occurs first.
    Time between the date of randomization and the date of progression or death, whichever occurs first.
    Time between the date of randomization and the date of progression or death, whichever occurs first.
    Time between the date of randomization and the date of progression or death, whichever occurs first.
    Time between the date of randomization and the date of progression or death, whichever occurs first.
    Time between the date of randomization and the date of progression or death, whichever occurs first.
    PFS2
    Tempo tra la data di randomizzazione e la data di progressione o decesso, a seconda di quale si verifichi prima
    Tempo tra la data di randomizzazione e la data di progressione o decesso, a seconda di quale si verifichi prima.
    Tempo tra la data di randomizzazione e la data di progressione o decesso, a seconda di quale si verifichi prima
    Tempo tra la data di randomizzazione e la data di progressione o decesso, a seconda di quale si verifichi prima
    Tempo tra la data di randomizzazione e la data di progressione o decesso, a seconda di quale si verifichi prima
    Tempo tra la data di randomizzazione e la data di progressione o decesso, a seconda di quale si verifichi prima
    PFS2
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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
    Nessun Trattamento
    No treatment
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    In Arm A maintenance Fulvestrant will be given until disease progression, unacceptable toxicity or refused of patient to the treatment.
    Nel braccio A il mantenimento con Fulvestrant verrà dato fino alla progressione della malattia, tossicità inaccettabile o rifiuto del paziente al trattamento 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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 state156
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 156
    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 Decision2015-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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