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    EudraCT Number:2014-004010-28
    Sponsor's Protocol Code Number:I3Y-MC-JPBO(a)
    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:2020-11-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-004010-28
    A.3Full title of the trial
    A Phase 2 Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma
    Studio di fase 2 di Abemaciclib in pazienti con metastasi cerebrali secondarie da carcinoma della mammella con recettori ormonali positivi, carcinoma polmonare non microcitoma o melanoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-Small Cell Lung Cancer, or Melanoma That Has Spread to the Brain
    Uno studio di Abemaciclib (LY2835219) in partecipanti con carcinoma della mammella, carcinoma polmonare non a piccole cellule o melanoma che ha invaso il cervello
    A.3.2Name or abbreviated title of the trial where available
    A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-Small Cell Lung Cancer, o
    A.4.1Sponsor's protocol code numberI3Y-MC-JPBO(a)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02308020
    A.5.4Other Identifiers
    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.1.3.4CountryUnited States
    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 supportEli Lilly and Company Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00390554257386
    B.5.5Fax number00390554257348
    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.2.1.2Country 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 nameAbemaciclib
    D.3.2Product code LY28335219
    D.3.4Pharmaceutical form Capsule, hard
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Brain tumors, Breast Cancer
    Tumore del cervello, Carcinoma della mammella
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Carcinoma della mammella
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    The primary objective of this study is to evaluate abemaciclib with respect to OIRR (complete response [CR] + partial response [PR]) based on tumor assessments and Response Assessment in Neuro-Oncology brain metastases response assessment criteria (RANO-BM):
    ¿ in patients with brain metastases secondary to HR+, HER2+ breast cancer.
    ¿ in patients with brain metastases secondary to HR+, HER2- breast cancer.
    ¿ in patients with brain metastases secondary to NSCLC.
    ¿ in patients with brain metastases secondary to melanoma.
    l¿obiettivo primario di questo studio ¿ esaminare abemaciclib in termini di OIRR (risposta completa [CR] + risposta parziale [PR]) in base alle valutazioni del tumore e ai criteri di valutazione della risposta RANO-BM (Response Assessment in Neuro-Oncology-Brain Mestastases):
    ¿ in pazienti con metastasi cerebrali secondarie a carcinoma mammario HR+, HER2+;
    ¿ in pazienti con metastasi cerebrali secondarie a carcinoma mammario HR+, HER2-;
    ¿ in pazienti con metastasi cerebrali secondarie a NSCLC;
    ¿ in pazienti con metastasi cerebrali secondarie a melanoma.
    E.2.2Secondary objectives of the trial
    Evaluate abemaciclib with respect to:
    - Intracranial disease per RANO-BM
    - Best overall intracranial response (BOIR)
    - Duration of intracranial response (DOIR) (CR + PR)
    - Intracranial disease control rate (IDCR) (CR + PR + stable disease [SD])
    - Intracranial clinical benefit rate (ICBR) (CR + PR + SD =6 months)
    - Overall survival (OS)
    - Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and RANO-BM
    - Disease control rate (DCR) (CR+ PR+ SD) per RECIST v1.1 and RANO-BM
    - Progression free survival (PFS) per RECIST v1.1 and RANO-BM
    - Change in symptoms as assessed by MD Anderson Symptom Inventory ¿ Brain Tumor (MDASI-BT)
    - Safety and tolerability
    - PK of abemaciclib and its metabolites
    Gli obiettivi secondari dello studio consistono nella valutazione di abemaciclib in termini di:
    ¿ Malattia intracranica secondo i criteri RANO-BM
    o migliore risposta intracranica globale (BOIR)
    o durata della risposta intracranica (DOIR) (CR + PR)
    o tasso di controllo della malattia intracranica (IDCR: CR + PR + malattia stabile [SD])
    o tasso di beneficio clinico intracranico (ICBR) (CR + PR + SD =6 mesi)
    ¿ Malattia nel suo complesso
    o sopravvivenza globale (OS)
    o tasso di risposta obiettiva (ORR) secondo i criteri RECIST (Response Evaluation Criteria in Solid Tumors) versione 1.1 e RANO-BM
    o tasso di controllo della malattia (DCR) (CR+ PR+ SD) secondo i criteri RECIST versione 1.1 e RANO-BM
    o Sopravvivenza libera da progressione (PFS) secondo i criteri RECIST versione 1.1 e RANO-BM
    ¿ Variazione dei sintomi valutata mediante il questionario MDASI-BT (MD Anderson Symptom Inventory ¿ Brain Tumor)
    ¿ Sicurezza e tollerabilit¿
    ¿ PK di abemaciclib e dei relativi metaboliti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] have brain metastases secondary to histologically or cytologically confirmed HR+ breast cancer, NSCLC, or melanoma.
    [2] Deleted criterion.
    [3] For Parts A,B, D and E: have =1 new or not previously irradiated measurable metastatic brain lesion =10 mm in the longest diameter (LD) or a progressive previously irradiated metastatic brain lesion on radiographic imaging by gadolinium-enhanced magnetic resonance imaging (Gd MRI).
    For Part C (surgical): have metastatic brain lesion(s) for which surgical resection is clinically indicated.
    [4] have completed local therapy (surgical resection, WBRT, or SRS) =14 days prior to initiating abemaciclib and recovered from all acute effects. Patients are not required to have received prior local therapy for study participation.
    [5] if receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
    [6] have a Karnofsky performance status of =70 (see Attachment 4)
    [7] have a life expectancy =12 weeks.
    [8] for HR+ breast cancer patients in Parts A, B, C, and F: if currently receiving endocrine therapy, a patient may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and CNS disease progression has occurred while on this endocrine therapy. If these conditions are not met, patients must discontinue endocrine therapy prior to initiation of abemaciclib.
    For HER2+ breast cancer patients in Parts A, C, and F: patients may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with intravenous (IV) trastuzumab. Concurrent treatment with trastuzumab emtansine (T-DM1) is not allowed.
    For NSCLC patients in Parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a patient may continue to receive 1 of these 2 therapies as a single agent provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy. Combination therapies (aside from gemcitabine or pemetrexed) must be discontinued for at least 14 days prior to initiation of abemaciclib.
    [9] have discontinued all previous therapies for cancer (including cytotoxic chemotherapy, targeted therapy [including, but not limited to, everolimus], radiotherapy, immunotherapy, and investigational therapy) for at least 14 days prior to receiving abemaciclib and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia or peripheral neuropathy.
    [10] for HER2+ breast cancer patients in Parts A, C, and F: patients receiving concurrent IV trastuzumab, must have left ventricular ejection fraction within investigative site’s normal range.
    1) metastasi cerebrali secondarie a carcinoma mammario HR+, NSCLC o melanoma confermato istologicamente o citologicamente; 2) criterio eliminato; 3) =1 lesione cerebrale metastatica misurabile di nuova formazione o precedentemente irradiata con diametro massimo di =10 mm o una lesione cerebrale metastatica progressiva precedentemente irradiata (Parti A, B, D ed E) o lesioni cerebrali metastatiche per le quali è clinicamente indicata la resezione chirurgica (Parte C [chirurgica]); 4) completamento della terapia a livello locale (resezione chirurgica, radioterapia panencefalica o radiochirurgia stereotassica) =14 giorni prima dell’inizio del trattamento con abemaciclib e risoluzione di tutti gli effetti acuti; 5) se in trattamento concomitante con steroidi, la dose deve essere stabile o in diminuzione da almeno 7 giorni prima della risonanza magnetica con gadolinio (Gd); 6) performance status di Karnofsky =70; 7) aspettativa di vita =12 settimane; 8) pazienti con carcinoma mammario HR+ nelle Parti A, B, C ed F: se in trattamento con terapia endocrina, potranno proseguirla a condizione che la malattia extracranica sia stabile da almeno 3 mesi e la progressione della malattia del SNC si sia verificata durante la terapia endocrina (in assenza di questi requisiti, i pazienti dovranno interrompere la terapia endocrina prima di iniziare il trattamento con abemaciclib); pazienti con carcinoma mammario HER2+ nelle Parti A, C ed F: i pazienti potranno essere sottoposti a trattamento concomitante (in corso o iniziato contemporaneamente ad abemaciclib) con trastuzumab per via endovenosa (ev). Il trattamento concomitante con trastuzumab emtansine (T-DMI1) non è consentito; pazienti con NSCLC nelle Parti C, D ed F: se attualmente in trattamento con gemcitabina o pemetrexed (in monoterapia o in associazione a un’altra terapia), i pazienti potranno continuare a ricevere 1 di questi 2 farmaci in monoterapia a condizione che la malattia extracranica sia stabile da almeno 6 settimane e la progressione della malattia del SNC sia avvenuta durante tale terapia. Le terapie di associazione (eccetto gemcitabina e pemetrexed) devono essere state interrotte almeno 14 giorni prima dell’inizio del trattamento con abemaciclib; 9) interruzione di tutte le precedenti terapie antitumorali da almeno 14 giorni prima di iniziare la somministrazione di abemaciclib e risoluzione di tutti gli effetti acuti della terapia (nota: le eccezioni relative ai trattamenti concomitanti sono indicate al criterio [8]; 10) pazienti con carcinoma mammario HER2+ nelle Parti A, C ed F:i pazienti in trattamento concomitante con trastuzumab devono presentare una frazione di eiezione ventricolare sinistra entro il normale intervallo previsto dal centro di sperimentazione
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [16] require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.
    [17] require concurrent anticancer treatment at any time during the study treatment period.
    [18] are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).
    [19] have evidence of significant (ie, symptomatic) intracranial hemorrhage.
    [20] for Parts A, B, C, D, and E: have evidence of leptomeningeal metastases by clinical signs and symptoms associated with abnormal MRI features or by documented CSF cytology.
    [21] have experienced >2 seizures within 4 weeks prior to study entry.
    [22] have visceral crisis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
    [23] for Parts A, B, D, E, and F: have previously received treatment with any CDK4 and CDK6 inhibitor. Part C patients may have received prior palbociclib or ribociclib, but not abemaciclib, treatment.
    [24] have known contraindication to Gd-MRI.
    [25] deleted criterion.
    [26] are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [27] have received treatment with a drug that has not received regulatory approval for any indication within 14 days of the initial dose of abemaciclib.
    [28] have a personal history within the last 12 months of any ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest.
    [29] have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel).
    [30] have a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea.
    [31] have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
    [32] are lactating.
    [33] have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies). Screening is not required for enrollment.
    [34] have an acute bacterial infection requiring IV antibiotics.
    [35] have received recent (within 28 days of initial dose of abemaciclib) or concurrent yellow fever vaccination.
    I pazienti saranno esclusi dallo studio se soddisferanno uno qualsiasi dei seguenti criteri: 16) necessità immediata di sottoporsi a terapie locali, quali, a titolo di esempio, radioterapia panencefalica, radiochirurgia stereotassica o resezione chirurgica, per il trattamento delle metastasi cerebrali; 17) necessità di terapie antitumorali concomitanti in qualsiasi momento durante il periodo di trattamento in studio (a eccezione delle terapie indicate al criterio [8] o della resezione chirurgica [solo pazienti nella Parte C]); 18) trattamento concomitante con farmaci antiepilettici induttori enzimatici; 19) evidenze di significativa (ovvero sintomatica) emorragia intracranica; 20) Parti A, B, C, D ed E: evidenze di metastasi leptomeningee in base a segni e sintomi clinici associati ad anomalie alla RM o in base a una citologia del LCS precedentemente documentata; 21) >2 crisi epilettiche nelle 4 settimane precedenti l’ingresso nello studio; 22) crisi viscerale; 23) Parti A, B, D, E ed F: pregresso trattamento con un qualsiasi inibitore della CDK4 e della CDK6; i pazienti nella Parte C potranno essere stati sottoposti a un precedente trattamento con palbociclib o ribociclib, ma non con abemaciclib; 24) controindicazione nota alla RM con Gd; 25) criterio eliminato; 26) attuale partecipazione a uno studio clinico che prevede l’impiego di un prodotto sperimentale o l’utilizzo non approvato di un farmaco o un dispositivo (diverso dal farmaco sperimentale utilizzato in questo studio) o partecipazione concomitante a qualsiasi altro tipo di ricerca medica giudicata non compatibile con il presente studio da un punto di vista scientifico o medico; 27) trattamento con un farmaco che non abbia ricevuto l’approvazione regolatoria per una qualsiasi indicazione nei 14 giorni precedenti la dose iniziale di abemaciclib; 28) anamnesi personale di aritmia ventricolare di qualsiasi tipo (inclusa a titolo di esempio la tachicardia ventricolare e la fibrillazione ventricolare) o arresto cardiaco improvviso negli ultimi 12 mesi; 29) condizioni mediche preesistenti serie che, secondo il giudizio dello sperimentatore, impedirebbero la partecipazione allo studio; 30) condizione cronica preesistente che provoca diarrea di grado pari o superiore a 2 al basale; 31) anamnesi positiva per qualsiasi altro tipo di cancro (a eccezione del tumore cutaneo non melanomatoso e del carcinoma in situ della cervice), salvo in caso di remissione completa senza terapia da almeno 3 anni; 32) donne in allattamento; 33) infezione fungina sistemica in atto e/o virale nota; 34) infezione batterica acuta che richiede la somministrazione di antibiotici per via endovenosa (ev); 35) vaccinazione per la febbre gialla recente o concomitante.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Intracranial Response Rate (OIRR) assessed using RANO-BM
    OIRR valutata utilizzando la RANO-BM
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Objective Disease Progression (Approximately 6 Months)
    Dal Basaline alla Progressione obiettiva della patologia (circa 6 mesi)
    E.5.2Secondary end point(s)
    Best Overall Intracranial Response (BOIR)
    Duration of intracranial response (DOIR) (CR + PR)
    Intracranial disease control rate (IDCR)
    Intracranial Clinical Benefit Rate (ICBR)
    Overall Survival (OS)
    Objective Response Rate (ORR)
    Disease Control Rate (DCR)
    Progression Free Survival (PFS)
    Change from Baseline to End of Study in Neurologic Symptoms on the MD
    Anderson Symptom Inventory-Brain Tumor (MDASI-BT) Scale
    Pharmacokinetics (PK): Minimum Concentration (Cmin) of Abemaciclib and its Metabolites
    ¿ Migliore risposta intracranica complessiva (BOIR)
    ¿ Durata della risposta intracranica (DOIR)
    ¿ Tasso di controllo della risposta intracranica (IDCR)
    ¿ Tasso di beneficio clinico a livello intracranico (ICBR)
    ¿ Sopravvivenza complessiva (OS)
    ¿ Tasso di risposta obiettiva (ORR)
    ¿ Tasso di controllo della patologia (DCR)
    ¿ Progressione libera da malattia (PFS)
    ¿ Cambiamento dal Basale alla Fine dello Studio nei sintomi neurologici sulla scala MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT)
    ¿ Farmacocinetica (PK): minima concentrazione (Cmin) di Abemaciclib e suoi metaboliti

    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Earliest Objective Progression or Start of New Anticancer
    Therapy (Approximately 6 Months)
    Date of Complete Response or Partial Response to Date of Objective
    Disease Progression or Death from Any Cause (Approximately 6 Months)
    Baseline to Disease Progression or Start of New Anticancer Therapy
    (Approximately 6 Months)
    Baseline to Death from Any Cause (Approximately 18 Months)
    Baseline to Disease Progression (Approximately 6 Months)
    Baseline to Disease Progression or Start of New Anticancer Therapy
    (Approximately 6 Months)
    Baseline to Objective Disease Progression or Death from Any Cause
    (Approximately 6 Months)
    Baseline, End of Study (Approximately 6 Months)
    Cycle 1 through Cycle 4 (Approximately 3 Months)
    ¿ Dal Basale alla prima progressione obiettiva o all'inizio di una nuova terapia anti-cancro (circa 6 mesi)
    ¿ Data di risposta completa o risposta parziale alla data dell'obiettivo di progressione di malattia o morte da qualsiasi altra causa (circa 6 mesi)
    ¿ Dal Baseline alla morte per qualsiasi causa (circa 18 mesi)
    ¿ Dal Baseline alla progressione di malattia (circa 6 mesi)
    ¿ Dal Baseline ala Progressione di malattia o l'inizio di una nuova terapia anti tumorale (circa 6 mesi)
    ¿ Dal Baseline alla progressione di malattia obiettiva o morte per qualsiasi causa (approssimativamente 6 mesi)
    ¿ Baseline, Fine dello Studio (circa 6 mesi)
    ¿ Dal Ciclo 1 al Ciclo 4 (Circa 3 mesi)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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. 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Information not present in EudraCT
    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 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
    End of trial refers to the date of the last visit or last scheduled procedure for the last patient. The end of trial occurs after study completion and after the last patient has discontinued study treatment and completed any applicable continued access follow-up
    La fine dello studio si riferisce all'ultima visita o all'ultima procedura programmata per l'ultimo paziente. La fine dello studio avviene dopo il completamento dello studio e dopo che l'ultimo paziente ha sospeso il trattamento in studio e completato ogni continued access follow up applicabile
    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 months3
    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 months3
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 120
    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)
    Post-treatment discontinuation follow up starts just after the last dose of study drug and ends when final safety assessments are completed 30 days (¿5) after last dose of study drug. Long term follow up begins after the day short term post discontinuation follow up visits is completed and continues until the patient¿s death, lost to follow-up, or overall study completion.
    Post-treatment discontinuation follow up inizia subito dopo l'ultima dose del farmaco in studio e finisce quando le valutazioni finali di sicurezza sono state completate 30 giorni (¿5) dopo l'ultima dose del farmaco in studio. Il follow up a lungo termine inizia il giorno dopo che ¿ stata completata la visita di follow up della sospensione a breve termine e continua fino alla morte del paziente, perdita al follow up o completamento complessivo dello studio.
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
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