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    Summary
    EudraCT Number:2019-003706-27
    Sponsor's Protocol Code Number:D8530C00002
    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:2021-01-22
    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 number2019-003706-27
    A.3Full title of the trial
    SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer
    SERENA-2: Studio randomizzato, in aperto, a gruppi paralleli, multicentrico, di Fase 2 per confrontare l’efficacia e la sicurezza di AZD9833 somministrato per via orale rispetto a fulvestrant in donne affette da carcinoma mammario ER-positivo HER2-negativo in stadio avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SERENA-2: A Randomised Comparative Phase 2 Study of AZD9833 versus Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast Cancer
    SERENA-2: Studio randomizzato comparativo di Fase 2 di AZD9833 rispetto a fulvestrant in donne affette da carcinoma mammario ER-positivo HER2-negativo in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    SERENA-2
    SERENA-2
    A.4.1Sponsor's protocol code numberD8530C00002
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number0013028851180
    B.5.5Fax number000000
    B.5.6E-mailinformation.center@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD9833
    D.3.2Product code [-]
    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.3.9.2Current sponsor codeAZD9833
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.2.5The 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 nameAZD9833
    D.3.2Product code [-]
    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.3.9.2Current sponsor codeAZD9833
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 250 mg solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje, Sweden
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 name-
    D.3.2Product code [-]
    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.3.8INN - Proposed INNFulvestrant
    D.3.9.1CAS number 129453-61-8
    D.3.9.2Current sponsor code-
    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 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
    Estrogen Receptor Positive HER2 Negative Advanced Breast Cancer
    Carcinoma mammario ER-positivo HER2-negativo in stadio avanzato
    E.1.1.1Medical condition in easily understood language
    Advanced Breast Cancer
    Carcinoma mammario in stadio avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced 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 determine the clinical efficacy (as assessed by PFS) of AZD9833 when compared to fulvestrant in women with advanced ER-positive HER2-negative breast cancer
    Determinare l’efficacia clinica (come valutato dalla PFS) di AZD9833 rispetto a fulvestrant in donne con carcinoma mammario ER-positivo HER2-negativo in stadio avanzato
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of AZD9833 when compared to fulvestrant in women with advanced ER positive HER2 negative breast cancer.

    To determine anti-tumour effect of AZD9833 when compared to fulvestrant in women with advanced ER positive HER2 negative breast cancer.

    To determine the effect of AZD9833 on survival and clinical benefit when compared to fulvestrant in women with advanced ER positive HER2 negative breast cancer

    To evaluate the PK of AZD9833 in this patient population at steady state.

    To evaluate the pharmacodynamics of AZD9833 and fulvestrant in a subgroup of patients with advanced ER positive HER2-negative breast cancer.

    To evaluate the effect of AZD9833 and fulvestrant on the patients' HRQoL, as assessed by patient completed HRQoL questionnaires.
    Determinare l’effetto antitumorale di AZD9833 rispetto a fulvestrant in donne con carcinoma mammario ER-positivo HER2-negativo in stadio avanzato

    Determinare l’effetto di AZD9833 sulla sopravvivenza e i suoi benefici clinici rispetto a fulvestrant in donne con carcinoma mammario ER-positivo HER2-negativo in stadio avanzato

    Valutare la PK di AZD9833 in questa popolazione di pazienti allo steady state

    Valutare la farmacodinamica di AZD9833 e di fulvestrant in un sottogruppo di pazienti con carcinoma mammario ER-positivo HER2-negativo in stadio avanzato

    Valutare l’effetto di AZD9833 e fulvestrant sulla HRQoL delle pazienti, secondo la valutazione ottenuta dai questionari HRQoL completati dalle pazienti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling, and analyses. Patients are also required to consent to the provision of archival tumour biopsies.
    • For patients who consent, provision of signed and dated written genetic informed consent prior to collection of sample for genetic analysis.
    • Female patients aged at least 18 years.
    • Post-menopausal as per the defined criteria.
    • Histologically or cytological confirmation of adenocarcinoma of the breast.
    • ER-positive status of primary or metastatic tumour tissue.
    • HER2-negative.
    • Metastatic disease or loco-regionally recurrent disease suitable for treatment with fulvestrant.
    • Radiological or other objective evidence of progression on or after the last systemic therapy prior to starting study treatment.
    • Patients must have at least 1 lesion, not previously irradiated, that can be measured accurately at baseline as >=10 mm in the longest diameter or in absence of measurable disease as defined above, at least 1 lytic or mixed (lytic+sclerotic) bone lesion.
    • Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1.
    Inclusion criteriion for the paired tumour biopsy research subgroup
    • Washout from prior tamoxifen: 4 months to elapse from last tamoxifen dose to pre-dose on-study biopsy.
    • Fornitura del consenso informato scritto, firmato e datato, prima di qualsiasi specifica procedura, prelievo di campione e analisi obbligatori dello studio. Ai pazienti viene, inoltre, richiesto il consenso alla fornitura di biopsie di tessuto tumorale archiviato.
    • Per i pazienti che vi acconsentono, fornitura del consenso informato genetico scritto, firmato e datato, prima del prelievo del campione per l’analisi genetica.
    • Pazienti di sesso femminile di almeno 18 anni di età.
    • In post-menopausa secondo i criteri definiti.
    • Conferma istologica o citologica di adenocarcinoma della mammella.
    • Stato positivo a ER del tessuto tumorale primario o metastatico.
    • Negativo a HER2.
    • Malattia metastatica o malattia ricorrente a livello loco-regionale idonea al trattamento con fulvestrant.
    • Evidenza radiologica o altra evidenza obiettiva di progressione durante o dopo l’ultima terapia sistemica prima di iniziare il trattamento dello studio.
    • Le pazienti devono presentare almeno 1 lesione, non precedentemente irradiata, che possa essere misurata con precisione al basale come >=10 mm nel diametro più lungo o in assenza di malattia misurabile come definita sopra, almeno 1 lesione ossea litica o mista (litica+sclerotica).
    • Stato di validità secondo il Gruppo cooperativo orientale di oncologia (ECOG)/l’Organizzazione Mondiale della Sanità (OMS) da 0 a 1.
    Criterio di inclusione per il sottogruppo di ricerca sulla biopsia tumorale accoppiata
    • Wash-out da precedente terapia con tamoxifene: devono essere trascorsi 4 mesi dall’ultima dose con tamoxifene alla biopsia pre-dose durante lo studio.
    E.4Principal exclusion criteria
    • Intervention with any of the following:
    o Any cytotoxic chemotherapy, investigational agents or other anticancer drugs for the treatment of breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of
    study treatment.
    o Use of systemic oestrogen-containing hormone replacement therapy within 6 months prior to the first dose of study treatment.
    o Medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 (CYP) 3A4/5, sensitive CYP2B6 substrates and drugs which are substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index ie, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
    o Drugs that are known to prolong QT and have a known risk of torsades de pointes.
    o The following cardiovascular criteria: QTcF >470 ms, resting heart rate <45 bpm, clinically significant abnormalities of resting ECG, uncontrolled hypertension, symptomatic hypotension, factors that increase the risk for QTc prolongation, LVEF <50%
    o Radiotherapy with a limited field of radiation for palliation.
    o Major surgical procedure or significant traumatic injury.
    • Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system (CNS) metastatic disease.
    • Inadequate bone marrow reserve or organ function.
    • Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833.
    • History of hypersensitivity to active or inactive excipients of AZD9833 or fulvestrant.
    • Previous randomisation in the present study.
    • Women of childbearing potential.
    • Intervento con uno qualsiasi dei seguenti mezzi:
    o Qualsiasi chemioterapia citotossica, agente sperimentale o altro farmaco antitumorale per il trattamento del carcinoma mammario da un precedente regime di trattamento o studio clinico entro 14 giorni dalla prima dose del trattamento dello studio.
    o Uso di terapia ormonale sostitutiva sistemica contenente estrogeni nei 6 mesi precedenti alla prima dose di trattamento dello studio.
    o Farmaci o integratori a base di erbe noti per essere forti inibitori/induttori del citocromo P450 (CYP) 3A4/5, substrati sensibili di CYP2B6 e farmaci che sono substrati di CYP2C9 e/o CYP2C19 che hanno un indice terapeutico ristretto, cioè warfarin (e altri anticoagulanti antagonisti della vitamina K derivanti dalla cumarina) e fenitoina.
    o Farmaci noti per prolungare il QT e che presentano un rischio noto di torsade de pointes.
    o I seguenti criteri cardiovascolari: QT corretto con formula di Fridericia (QTcF) > 470 ms, frequenza cardiaca a riposo < 45 bpm, anomalie clinicamente significative dell’ECG a riposo, ipertensione non controllata, ipotensione sintomatica, fattori che aumentano il rischio di prolungamento del QT corretto (QTc), frazione di eiezione ventricolare sinistra (LVEF) <50%
    o Radioterapia con radiazioni a campo ristretto a fini palliativi.
    o Intervento chirurgico maggiore o lesione traumatica significativa.
    • Presenza di malattia metastatica viscerale potenzialmente letale o malattia metastatica non controllata del sistema nervoso centrale (SNC).
    • Riserva di midollo osseo o funzione d’organo inadeguata.
    • Nausea e vomito refrattari, malattie gastrointestinali croniche non controllate, incapacità di deglutire il prodotto formulato o precedente resezione intestinale significativa che precluderebbe un adeguato assorbimento di AZD9833.
    • Anamnesi di ipersensibilità al principio attivo o agli eccipienti inattivi di AZD9833 o fulvestrant.
    • Precedente randomizzazione al presente studio.
    • Donne potenzialmente fertili.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary analysis will be conducted when sufficient events have accrued for the treatment comparison at approximately 60% maturity.
    L'analisi primaria sarà condotta quando si saranno accumulati eventi sufficienti per la comparazione del trattamento, con una maturità di circa il 60%.
    E.5.2Secondary end point(s)
    - Objective response rate
    - Duration of response
    - Percentage change in tumour size in tumour size at 16 weeks
    - Overall survival
    - Clinical benefit rate at 24 weeks
    - Plasma concentrations of AZD9833 and, if appropriate, metabolite(s)
    - Percent change from baseline in ER and progesterone receptor (PgR) expression assessed by the manual H-score method
    - Percent change from baseline in Ki67 labelling index
    - Changes from baseline in total/subscale scores of the HrQoL questionnaires
    - tasso di risposta oggettivo
    - durata della risposta
    - variazione percentuale delle dimensioni del tumore a 16 settimane
    - sopravvivenza globale
    - tasso di beneficio clinico a 24 settimane
    - concentrazioni plasmatiche di AZD9833 e, se appropriato, di metabolita(i)
    - Variazione percentuale dal basale dell’espressione di ER e del recettore del progesterone (PgR), valutato mediante il metodo H-Score manuale.
    - Variazione percentuale dal basale dell’indice di etichettatura Ki67
    - Variazioni dal basale dei punteggi totali/sottoscala dei questionari HrQoL
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated at the end of the trial.
    Survival analyses may be conducted at 50% and 75% overall survival maturity
    Gli endpoint secondari saranno valutati alla fine dello studio.
    Le analisi di sopravvivenza potranno essere condotte ad una maturità della sopravvivenza globale del 50% e del 75%.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 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 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 trial4
    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 EEA85
    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
    Georgia
    Israel
    Mexico
    Peru
    Russian Federation
    Ukraine
    United States
    Belgium
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Spain
    United Kingdom
    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
    The end of the study is defined as the last expected visit/contact of the last patient undergoing the study.
    La fine dello studio è definita come ultima visita/contatto prevista/o dell'ultimo paziente in studio.
    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 years3
    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: 183
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 183
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 366
    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)
    Subsequent anti-cancer treatment (after study treatment discontinuation) will be at the discretion of the patient's treating physician and should be recorded in the CRF.
    I successivi trattamenti anti-tumorali (dopo interruzione con trattamento in studio) saranno a discrezione del medico curante del paziente e dovranno essere registrati in CRF.
    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 Decision2020-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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