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    Summary
    EudraCT Number:2021-000398-10
    Sponsor's Protocol Code Number:EFC16133
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-04-07
    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 number2021-000398-10
    A.3Full title of the trial
    A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor 2-negative or positive,
    stage IIB-III breast cancer who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity
    Studio di fase 3, randomizzato, multicentrico, in doppio cieco su amcenestrant (SAR439859) rispetto a tamoxifene per il trattamento di pazienti con carcinoma mammario in stadio IIB-III positivo al recettore ormonale, positivo o negativo al fattore 2 di crescita epidermico umano che hanno interrotto la terapia adiuvante con inibitori dell’aromatasi a causa di tossicità correlata al trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer, who have discontinued adjuvant aromatase inhibitor therapy due to treatmentrelated toxicity (AMEERA-6)
    Studio di amcenestrant (SAR439859) rispetto a tamoxifene in pazienti con carcinoma mammario allo stadio iniziale positivo al recettore ormonale (HR+) che hanno interrotto la terapia adiuvante con inibitori dell’aromatasi a causa di tossicità correlata al trattamento (AMEERA-6)
    A.3.2Name or abbreviated title of the trial where available
    AMEERA-6
    AMEERA-6
    A.4.1Sponsor's protocol code numberEFC16133
    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 SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi S.r.l
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressViale Luigi Bodio 37/B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800536389
    B.5.5Fax number000000
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 nameAmcenestrant
    D.3.2Product code [SAR439859]
    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 INNAmcenestrant
    D.3.9.2Current sponsor codeSAR439859
    D.3.9.4EV Substance CodeSUB186740
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 Tamoxifen citrate compresse (TEVA), 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTeva (RVG 10635)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameTamoxifene
    D.3.2Product code [.]
    D.3.4Pharmaceutical form 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 INNTAMOXIFENE CITRATO
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameTamoxifen citrate
    D.3.9.4EV Substance CodeSUB04672MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Breast cancer
    Carcinoma mammario
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Carcinoma mammario
    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 PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether amcenestrant once a day (QD) improves the invasive breast cancer-free survival (IBCFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment
    Determinare se amcenestrant assunto una volta al giorno (QD) migliora la sopravvivenza libera da carcinoma mammario invasivo (IBCFS) rispetto a tamoxifene QD utilizzato come trattamento adiuvante in pazienti con carcinoma mammario allo stadio iniziale
    E.2.2Secondary objectives of the trial
    -To determine whether amcenestrant once a day (QD) improves the invasive disease-free survival (IDFS) when compared to tamoxifen QD in patients with early breast cancer as adjuvant treatment
    -To evaluate the distant recurrence-free survival (DRFS) in both treatment arms
    -To evaluate the locoregional recurrences-free survival (LRRFS) in both treatment arms
    -To evaluate the overall survival (OS) in both treatment arms
    -To evaluate the breast cancer-specific survival (BCSS) in both treatment arms
    -To evaluate patient-reported overall treatment-related side effect bother, treatment-related symptoms, and quality of life in both treatment arms
    -To evaluate safety in both treatment arms
    -To characterize the pharmacokinetics (PK) of amcenestrant
    - Determinare se amcenestrant assunto una volta al giorno (QD) migliora la sopravvivenza libera da malattia invasiva (IDFS) rispetto a tamoxifene QD utilizzato come trattamento adiuvante in pazienti con carcinoma mammario allo stadio iniziale.
    - Valutare la sopravvivenza libera da recidiva a distanza (DRFS) in entrambi i bracci di trattamento
    - Valutare la sopravvivenza libera da recidive locoregionali (LRRFS) in entrambi i bracci di trattamento
    - Valutare la sopravvivenza globale (OS) in entrambi i bracci di trattamento
    - Valutare la sopravvivenza specifica per il carcinoma mammario (BCSS) in entrambi i bracci di trattamento
    - Valutare in entrambi i bracci di trattamento il fastidio complessivo degli effetti collaterali correlati al trattamento, i sintomi correlati al trattamento e la qualità della vita, riportati dal/dalla paziente
    - Valutare la sicurezza in entrambi i bracci di trattamento
    - Caratterizzare la farmacocinetica (PK) di amcenestrant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult participants with histologically confirmed diagnosis of adenocarcinoma of the breast with documentation of hormone receptor positive status, irrespective of human epidermal growth factor 2 (HER2)
    status
    NOTE: Participants with HER2-positive breast cancer are eligible only if they have completed their adjuvant anti-HER2 treatment and chemotherapy.
    -With Stage IIB or Stage III, early invasive breast cancer at diagnosis who have undergone breast surgery for the current malignancy.
    -Who have received prior aromatase inhibitors (AIs) (letrozole, anastrozole or exemestane or any sequence thereof) for at least 6 months and discontinued within 30 months from the initiation of the first AI administration due to AI treatment-related toxicity
    -Absence of advanced/metastatic disease
    -Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
    -Capable of giving signed informed consent
    - Partecipanti adulti con diagnosi istologicamente confermata di adenocarcinoma mammario con documentazione dello status del recettore ormonale positivo, indipendentemente dallo status di HER2
    NOTA: Partecipanti con carcinoma mammario HER2-positivo sono eleggibili solo se hanno completato il trattamento adiuvante anti-HER2 e la chemioterapia
    - Partecipanti allo stadio IIB o III, carcinoma mammario invasivo precoce alla diagnosi che sono stati sottoposti a intervento chirurgico al seno per l’attuale tumore maligno.
    - Partecipanti che hanno ricevuto precedenti inibitori delle aromatasi (AI) (letrozolo, anastrozolo o exemestane o qualsiasi loro sequenza) per almeno 6 mesi e che hanno interrotto l’assunzione entro 30 mesi dall’inizio della prima somministrazione di AI a causa della tossicità correlata al trattamento
    -Assenza di malattia avanzata/metastatica
    - Stato di funzionalità 0-1 secondo l’Eastern Cooperative Oncology Group (ECOG)
    - In grado di fornire il consenso informato firmato
    E.4Principal exclusion criteria
    -Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant and/or tamoxifen. Participants unable to swallow normally and to take tablet and capsules. Predictable poor compliance to oral treatment. Active inflammatory bowel disease or chronic diarrhea, active hepatitis A/B/C, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures
    -Prior breast cancer for which they received an AI
    -Any other solid tumor or lymphoma diagnosis is not allowed except if the participant has been free from disease for >/=5 years
    -Pregnant or nursing women, or women of child-bearing potential without a negative pregnancy test prior to randomization
    -Participants with unrecovered acute toxic effects of prior AI therapy or surgical procedures
    -Uncontrolled intercurrent illness, including psychiatric conditions that would limit compliance with study requirements
    -Treatment with any another SERD, tamoxifen or toremifene are not allowed as prior adjuvant therapy but could have been used as neoadjuvant therapy for a total duration of 3 months. Participants who
    were treated with a SERD, tamoxifen or toremifene in the neoadjuvant setting and who experienced disease progression are not allowed
    - Participant is receiving concurrent HER2 directed therapy. Appropriate wash out between the last dose of HER2 directed therapy and randomization should be at least 4 weeks
    - Storia medica o disturbi gastrointestinali in corso che potenzialmente influenzano l‘assorbimento di amcenestrant e/o tamoxifene. Partecipanti incapaci di deglutire normalmente e di assumere capsule o compresse. Prevedibile scarsa aderenza al trattamento orale. Malattia infiammatoria intestinale attiva o diarrea cronica, epatite A/B/C attiva, cirrosi epatica, sindrome dell’intestino corto o qualsiasi intervento chirurgico del tratto gastrointestinale superiore, comprese resezione gastrica o procedure di bendaggio.
    - Precedente carcinoma mammario per il quale si è ricevuto un AI
    - Qualsiasi altra diagnosi di tumore solido o linfoma non è consentita, tranne nel caso in cui il/la partecipante sia libero/a da malattia da >/= 5 anni
    - Donne in gravidanza o in allattamento, o donne in età fertile senza un test di gravidanza negativo prima della randomizzazione
    - Partecipanti con effetti tossici acuti non risolti dalla precedente terapia con AI o da procedure chirurgiche
    - Malattia intercorrente non controllata, incluse condizioni psichiatriche che limiterebbero l’aderenza ai requisiti dello studio
    - Non è consentito come precedente terapia adiuvante il trattamento con qualsiasi altro SERD, tamoxifene o toremifene ma potrebbe essere stato usato come terapia neoadiuvante per una durata totale di 3 mesi. I/Le partecipanti che sono stati/e trattati/e con un SERD, tamoxifene o toremifene nel contesto neoadiuvante e che hanno manifestato progressione di malattia non sono ammessi/e
    - Il/La partecipante sta ricevendo una terapia concomitante diretta contro HER2. Il periodo di sospensione appropriato tra l’ultima dose della terapia mirata a HER2 e la randomizzazione deve essere di almeno 4 settimane
    E.5 End points
    E.5.1Primary end point(s)
    Invasive breast cancer-free survival (IBCFS)
    Sopravvivenza libera da carcinoma mammario invasivo (IBCFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization up to approximately 10 years
    Dalla randomizzazione fino a circa 10 anni
    E.5.2Secondary end point(s)
    1) Invasive disease-free survival (IDFS)
    2) Distant recurrence-free survival (DRFS)
    3) Locoregional recurrences-free survival (LRRFS)
    4) Overall survival (OS)
    5) Breast cancer-specific survival (BCSS)
    6) Patient-reported overall treatment-related side effect bother as measured by the Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5)
    7) Patient-reported treatment-related symptoms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Breast cancer module (EORTC QLQ-B23) systemic therapy side effects scale
    8) Patient-reported quality of life as measured by the EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30) global health status/quality of life (GHQ) scale
    9) Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
    10) PK parameter: Plasma concentration of Amcenestrant
    1) Sopravvivenza libera da malattia invasiva (IDFS)
    2) Sopravvivenza libera da ricorrenza lontana (DRFS)
    3) Sopravvivenza libera da ricorrenza locoregionale (LRRFS)
    4) Sopravvivenza globale (OS)
    5) Sopravvivenza specifica per il carcinoma mammario (BCSS)
    6) Disturbo globale riportato dal paziente correlato al trattamento come misurato dal Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5)
    7) Sintomi riportati dal paziente correlati al trattamento come riportato dall’ European Organisation for Research and Treatment of Cancer (EORTC). Questionario sulla qualità della vita, modulo specifico per il carcinoma mammario (EORTC QLQ-B23)
    8) Qualità della vita riportata dal paziente come misurato dal EORTC Core Quality of Life, modulo specifico per stato di salute globale/qualità della vita (GHQ)
    9) Numero di partecipanti con eventi avversi emergenti dal trattamento (TEAEs) e eventi avversi seri (SAEs)
    10) Parametri farmacocinetici: concentrazione plasmatica di amcenestrant
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/2/3/4/5)From randomization up to approximately 10 years
    6)From baseline up to 2 years after the end of treatment (up to approximately 7 years)
    7)From baseline up to 2 years after the end of treatment (up to approximately 7 years)
    8)From baseline up to 2 years after the end of treatment (up to approximately 7 years)
    9)Up to 30 days after the end of treatment, approximately 5 years
    10)Pre-administration day 1 of cycles 2, 7, 13 and 25 (each cycle is 28 days)
    1/2/3/4/5) Dalla randomizzazione fino a circa 10 anni
    6) dal basale fino a 2 anni dopo la fine del trattamento (fino a circa 7 anni)
    7) dal basale fino a 2 anni dopo la fine del trattamento (fino a circa 7 anni)
    8) dal basale fino a 2 anni dopo la fine del trattamento (fino a circa 7 anni)
    9) fino a 30 giorni dopo la fine del trattamento, approssimativamente 5 anni
    10) giorno 1 di pre-somministrazione dei cicli 2,7,13 e 25 (ogni ciclo dura 28 giorni)
    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.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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned26
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    China
    Georgia
    India
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Denmark
    Estonia
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Portugal
    Sweden
    United Kingdom
    Spain
    Switzerland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years12
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3970
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 700
    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 state133
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1072
    F.4.2.2In the whole clinical trial 4670
    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)
    None
    Nessuno
    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 Decision2022-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-16
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