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    Summary
    EudraCT Number:2016-003716-12
    Sponsor's Protocol Code Number:C34004
    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:2020-11-05
    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 number2016-003716-12
    A.3Full title of the trial
    Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy
    Studio di fase 2 su TAK-659 in pazienti con linfoma diffuso a grandi cellule B recidivante o refrattario dopo almeno 2 linee precedenti di chemioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    TAK-659 in pazienti con linfoma diffuso a grandi cellule B recidivante o refrattario
    A.3.2Name or abbreviated title of the trial where available
    TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    TAK-659 in pazienti con linfoma diffuso a grandi cellule B recidivante o refrattario
    A.4.1Sponsor's protocol code numberC34004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03123393
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1187-6208
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorMILLENNIUM PHARMACEUTICALS, INC.
    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 supportMillennium Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointStudy Registration Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018668352233
    B.5.5Fax number0010000000000
    B.5.6E-mailGlobalOncologyMedinfo@takeda.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.2.1.1.1Trade name NA
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 nameTAK-659
    D.3.2Product code [TAK-659]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNTAK-659
    D.3.9.2Current sponsor codeTAK-659
    D.3.9.4EV Substance CodeSUB179395
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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.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.2.1.1.1Trade name NA
    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 nameTAK-659
    D.3.2Product code [TAK-659]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNTAK-659
    D.3.9.2Current sponsor codeTAK-659
    D.3.9.3Other descriptive nameTAK-659
    D.3.9.4EV Substance CodeSUB179395
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Linfoma diffuso a grandi cellule B recidivante o refrattario
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Linfoma diffuso a grandi cellule B recidivante o refrattario
    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 HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of TAK-659 as measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in patients with diffuse large B-cell lymphoma (DLBCL) - (Stage 2).
    Valutare l’efficacia di TAK-659 misurata in base al tasso di risposta complessiva (ORR) secondo l’IRC in pazienti con DLBCL - (Fase 2).
    E.2.2Secondary objectives of the trial
    • To assess complete response (CR) rate per IRC in patients with DLBCL - (Stage 2).
    • To select the Stage 2 dose regimen of TAK-659 from the lead-in dose exploration phase (Stage 1) and assess the efficacy and safety using ORR per IRC (Stage 2).
    • To assess ORR per IRC at 3, 6, and 9 cycles in patients with DLBCL - (Stage 2).
    • To assess duration of response (DOR) and duration of CR per IRC in patients with DLBCL - (Stage 2).
    • To assess overall response rate (ORR) per IRC in the subgroup of patients with germinal center B-cell (GCB) DLBCL - (Stage 2).
    • To assess ORR per IRC in the subgroup of patients with DLBCL transformed from indolent lymphoma - (Stage 2).
    • To assess progression-free survival (PFS) per IRC in patients with DLBCL - (Stage 2).
    • To assess overall survival (OS) in patients with DLBCL - (Stage 2).
    • Valutare il tasso di CR secondo l’IRC in pazienti con DLBCL - (Fase 2).
    • Selezionare il regime di dosaggio di TAK-659 per la Fase 2 dalla fase di valutazione preliminare della dose (Fase 1) e valutare l’efficacia utilizzando l’ORR secondo l’IRC (Fase 2).
    • Valutare l'ORR secondo l'IRC ai cicli 3, 6 e 9 nei pazienti con DLBCL - (Fase 2).
    • Valutare la DOR e la durata della CR secondo l’IRC in pazienti con DLBCL - (Fase 2).
    • Valutare l’ORR secondo l’IRC nel sottogruppo dei pazienti con DLBCL a cellule B del centro germinale (GCB) - (Fase 2).
    • Valutare l’ORR secondo l’IRC nel sottogruppo dei pazienti con DLBCL derivante dalla trasformazione di un linfoma non-Hodgkin (LNH) indolente - (Fase 2).
    • Valutare la PFS secondo l’IRC in pazienti con DLBCL - (Fase 2).
    • Valutare l’OS in pazienti con DLBCL - (Fase 2).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18 years or older.
    2. Patients must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL. High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations (double-hit
    DLBCL under DLBCL, NOS, based on the 2008 WHO classification criteria) is not eligible for this study.
    a. Local pathology review for histological confirmation:
    - A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
    3. Relapsed or refractory to =2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy.
    4. For patients who have relapsed or progressed after achieving a response, documented, investigator-assessed relapse or progression after the last treatment is required.
    5. Must have FDG-PET–avid measurable disease that meets the size criteria per IWG as assessed on cross-sectional imaging by CT/MRI.
    6. ECOG performance status score of 0 or 1.
    7. Life expectancy of >3 months
    8. Patients must have adequate organ function, including the following:
    a. Bone marrow reserve: absolute neutrophil count (ANC) =1000/µL, platelet count =75,000/µL (=50,000/µL for patients with bone marrow involvement), and hemoglobin =8 g/dL (red blood cell [RBC] and
    platelet transfusion allowed =14 days before assessment).
    b. Hepatic: total bilirubin =1.5 times the upper limit of the normal range (ULN); ALT and AST =2.5xULN.
    c. Renal: creatinine clearance =60 mL/min either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).
    d. Others:
    •Lipase =1.5xULN and amylase =1.5xULN with no clinical symptoms suggestive of pancreatitis or cholecystitis.
    •Blood pressure =Grade 1 (hypertensive patients are permitted if their blood pressure is controlled to =Grade 1 by hypertensive medications and glycosylated hemoglobin is =6.5%).
    1. Pazienti di entrambi i sessi, di età pari o superiore a 18 anni
    2. Pazienti affetti da DLBCL istologicamente confermato, inclusa la malattia de novo o la malattia derivante dalla trasformazione di un LNH indolente. Il linfoma a cellule B ad alto grado con traslocazioni di MYC e BCL-2 e/o BCL-6 (DLBCL “double-hit” nell’ambito dei DLBCL, NAS, in base ai criteri della classificazione WHO 2008) non è considerato eleggibile per questo studio
    a. Revisione patologica locale per la conferma istologica: - Sono richiesti un blocchetto tumorale fissato in formalina, incluso in paraffina o vetrini opportunamente colorati ottenuti da una biopsia fresca.
    3. Malattia recidivante o refrattaria a =2 linee precedenti di chemioterapia basata sullo standard di cura con determinati requisiti per la terapia precedente.
    4. Per i pazienti che hanno manifestato recidiva o progressione dopo ottenimento di una risposta è necessario che la comparsa secondo la valutazione dello sperimentatore di recidiva o progressione dopo l’ultimo trattamento sia documentata
    5. Presentare una malattia captante alla tomografia a emissione di positroni con [18F]fluorodesossiglucosio (FDG-PET) che risponda ai criteri di dimensione per IWG misurabile mediante tomografia computerizzata (TC)/risonanza magnetica (RM)
    6. Punteggio dello stato di validità ECOG di 0 o 1
    7. Aspettativa di vita >3 mesi
    8. Presentare una funzione d’organo adeguata, incluso quanto indicato di seguito:
    a. Riserva midollare: conta assoluta dei neutrofili =1000/µl, conta piastrinica =75.000/µl (=50.000/µl per i pazienti con coinvolgimento del midollo osseo) ed emoglobina =8 g/dl (trasfusioni di emazie e piastrine consentite =14 giorni prima della valutazione).
    b. Funzione epatica: bilirubina totale =1,5 volte il limite superiore dell’intervallo di normalità (ULN); alanina aminotransferasi e aspartato aminotransferasi =2,5 x l’ULN.
    c. Funzione renale: clearance della creatinina =60 ml/min, come stimata mediante equazione di Cockcroft-Gault o in base alla raccolta delle urine (delle 12 o delle 24 ore).
    d. Altro:
    i. Lipasi =1,5 x ULN e amilasi =1,5 x ULN senza sintomi clinici suggestivi di pancreatite o colecistite.
    ii. Pressione sanguigna di grado =1 (i pazienti ipertesi sono ammessi se la pressione sanguigna è controllata a un grado =1 dai farmaci antipertensivi e l’emoglobina glicosilata è =6,5%)
    E.4Principal exclusion criteria
    1. CNS lymphoma; active brain or leptomeningeal metastases.
    2. Known human immunodeficiency virus (HIV)–related malignancy.
    3. Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment.
    4. Radiotherapy less than 3 weeks before the first dose of study treatment.
    5. Known HIV positive (testing not required).
    6. Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
    7. Prior ASCT within 6 months or prior ASCT at any time without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell transplant any time.
    8. Participants with certain cardiovascular conditions are excluded.
    9. Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
    10. Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
    11. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
    12. Patients with another malignancy within 2 years of study start. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are
    considered disease-free at the time of study entry.
    13. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
    14. Certain wash-out restrictions before the first dose of study drug on inhibitors of P-gp and/or strong reversible inhibitors of CYP3A, strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or Pgp inducers, grapefruit containing food or beverages.
    1. Linfoma del SNC; metastasi cerebrali o leptomeningee attive
    2. Malignità nota associata a infezione da virus dell’immunodeficienza umana
    3. Trattamento antitumorale sistemico (agenti sperimentali inclusi) meno di 3 settimane prima della prima dose di trattamento dello studio
    4. Radioterapia meno di 3 settimane prima della prima dose di trattamento dello studio
    5. Positività nota a infezione da virus dell’immunodeficienza umana (test non richiesto)
    6. Positività nota all'Antigene di superficie dell'epatite B o infezione attiva nota o sospetta per epatite C
    7. ASCT entro i 6 mesi precedenti o precedente ASCT eseguito in qualsiasi momento senza recupero ematopoietico completo prima del Ciclo 1 Giorno 1, oppure trapianto allogenico di cellule staminali eseguito in qualsiasi momento
    8. Presenza di determinate patologie cardiovascolari
    9. Interventi di chirurgia maggiore entro i 14 giorni precedenti la somministrazione della prima dose del farmaco in studio o guarigione incompleeta da qualsiasi complicanza esito di intervento chirurgico
    10. Infezione sistemica che richieda terapia antibiotica parenterale o altre infezioni gravi (batteriche, micotiche o virali) entro i 21 giorni precedenti la somministrazione della prima dose del farmaco in studio
    11. Trattamento con corticosteroidi ad alto dosaggio a scopo anticancerogeno entro i 7 giorni precedenti la prima somministrazione di TAK-659
    12. Pazienti con differente tumore maligno insorto entro 2 anni dall'inizio dello studio. I pazienti con tumore della pelle diverso dal melanoma o carcinoma in situ di qualsiasi tipo non saranno esclusi se sottoposti a resezione completa e considerati liberi da malattia al momento dell'ingresso nello studio.
    13. Patologia gastrointestinale (GI) nota o procedure GI che possano interferire con l'assunzione orale o la tolleranza diTAK-659
    14. Specifiche restrizioni di wash-out, prima della somministrazione della prima dose di farmaco in studio, di inibitori di P-gp e/o potenti inibitori reversibili di CYP3A, potenti inibitori del meccanismo del CYP3A o potenti induttori del CYP3A e/o induttori della P-gp, assunzione di alimenti o bevande contenenti pompelmo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is ORR as assessed by IRC according to the modified 2007 International Working Group (IWG) criteria for malignant lymphoma – (Stage 2).
    ORR come valutato dall’IRC in base ai criteri dell’ International Working Group (IWG) 2007 modificati per il linfoma maligno – (Fase 2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis - after all patients enrolled in the study have had the opportunity to complete 6 cycles of treatment with study drug. Conclusion of the study - when OS events have occurred in 70% of patients, or 24 months after last patient in, whichever occurs earlier.
    Analisi primaria - dopo che tutti i pazienti arruolati nello studio avranno avuto l'opportunità di completare 6 cicli di trattamento con il farmaco in studio. Conclusione dello studio - quando la sopravvivenza complessiva (OS) sarà occorsa nel 70% dei pazienti, o 24 mesi dopo l'arruolamento dell'ultimo paziente, quale dei due eventi occorra prima
    E.5.2Secondary end point(s)
    • CR rate as assessed by IRC according to the modified 2007 IWG criteria (Stage 2). • ORR per IRC according to the 2014 IWG (Lugano) criteria (Stage 2). • CR rate per IRC according to the 2014 IWG (Lugano) criteria (Stage 2). • ORR per IRC to select the Stage 2 dose regimen of TAK-659 from the lead-in dose exploration phase (Stage 1). • ORR per IRC at 3, 6, and 9 cycles, respectively (Stage 2). • DOR and duration of CR per IRC (Stage 2). • ORR per IRC in patients with GCB DLBCL (Stage 2). • ORR per IRC in patients with DLBCL transformed from indolent NHL (Stage 2). • PFS per IRC (Stage 2). • OS (Stage 2).
    • Tasso di CR come valutato dall’IRC in base ai criteri IWG 2007 modificati (Fase 2). • ORR secondo l’IRC in base ai criteri IWG 2014 (Lugano) (Fase 2). • Tasso di CR secondo l’IRC in base ai criteri IWG 2014 (Lugano) (Fase 2). • ORR secondo l’IRC per selezionare il regime di dosaggio di TAK-659 per la Fase 2 dalla fase di valutazione preliminare della dose (Fase 1) • ORR secondo l’IRC rispettivamente ai cicli 3, 6, e 9 cicli (Fase 2) • DOR e durata della CR secondo l’IRC (Fase 2). • ORR secondo l’IRC in pazienti con DLBCL GCB (Fase 2). • ORR secondo l’IRC in pazienti con DLBCL derivante dalla trasformazione di un LNH indolente (Fase 2). • PFS secondo l’IRC (Fase 2). • OS (Fase 2).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary analysis - after all patients enrolled in the study have had the opportunity to complete 6 cycles of treatment with study drug. Conclusion of the study - when OS events have occurred in 70% of patients, or 24 months after last patient in, whichever occurs earlier.
    Analisi primaria - dopo che tutti i pazienti arruolati nello studio avranno avuto l'opportunità di completare 6 cicli di trattamento con il farmaco in studio. Conclusione dello studio - quando la sopravvivenza complessiva (OS) sarà occorsa nel 70% dei pazienti, o 24 mesi dopo l'arruolamento dell'ultimo paziente, quale dei due eventi occorra prima
    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 No
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Canada
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    Conclusion of the study will be considered when OS events have occurred in 70% of patients, or 24 months after last patient in, whichever occurs earlier.
    Verrà considerata la conclusione dello studio quando gli eventi OS (sopravvivenza complessiva) saranno occorsi nel 70% dei pazienti, o 24 mesi dopo l'inclusione dell'ultimo paziente, quale dei due eventi si verifichi per primo
    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 months11
    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 months11
    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: 49
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 73
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 122
    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)
    The patient will receive the normal treatment of that condition, at investigator's discretion
    Il paziente riceverà il trattamento usuale per la condizione, a discrezione dello Sperimentatore
    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 Decision2017-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-09
    P. End of Trial
    P.End of Trial StatusCompleted
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