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    Summary
    EudraCT Number:2020-001642-18
    Sponsor's Protocol Code Number:D8230C00002
    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:2021-11-08
    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 number2020-001642-18
    A.3Full title of the trial
    A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations with Anti-cancer Agents in Patients with Advanced Haematological Malignancies
    Studio modulare multicentrico di fase I/II, in aperto, per valutare AZD4573 in nuove combinazioni con agenti antitumorali in pazienti con tumori maligni ematologici in stadio avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess AZD4573 in novel combination with acalabrutinib in participants with relapsed or refractory diffuse large B-cell lymphoma or relapsed or refractory marginal zone lymphoma
    AZD4573 in nuove combinazioni con agenti antitumorali in pazienti con tumori maligni ematologici in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    D8230C00002
    D8230C00002
    A.4.1Sponsor's protocol code numberD8230C00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04630756
    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 AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailinformation.centre@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 Yes
    D.2.1.1.1Trade name Calquence
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameAcalabrutinib
    D.3.2Product code [ACP-196]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAcalabrutinib
    D.3.9.1CAS number 1420477-60-6
    D.3.9.2Current sponsor codeACP-196
    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.2.5The 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 nameAZD4573
    D.3.2Product code [AZD4573]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZD4573
    D.3.9.1CAS number 2057509-72-3
    D.3.9.2Current sponsor codeAZD4573
    D.3.9.3Other descriptive nameAZ13810325
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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
    Haematological Malignancies
    Malignità ematologica
    E.1.1.1Medical condition in easily understood language
    Various cancers
    Varie malignità
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10066476
    E.1.2Term Haematological malignancy
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Module 1

    Part A : Assess the safety and tolerability, describe the DLTs, and identify the MTD and/or RP2D of AZD4573 in combination with acalabrutinib (100 mg BID)

    Part B: Assess the efficacy of AZD4573 in combination with acalabrutinib by evaluation of objective response rate
    Modulo 1

    Parte A: Valutare la sicurezza e la tollerabilità, descrivere le tossicità limitanti la dose (DLT) e identificare la dose massima tollerata (MTD) e/o la RP2D di AZD4573, in combinazione con acalabrutinib (100 mg BID)

    Parte B: Valutare l’efficacia di AZD4573 in combinazione con acalabrutinib tramite la valutazione del tasso di risposta obiettivo
    E.2.2Secondary objectives of the trial
    Module 1
    Part A and B :Assess the plasma PK of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination

    Part B: Assess efficacy of AZD4573 in combination with acalabrutinib by evaluation of tumour response and overall survival .
    Assess the safety and tolerability of the RP2D of AZD4573 in combination with acalabrutinib (100 mg BID)

    Exploratory:
    Part A : Assess efficacy of AZD4573 in combination with acalabrutinib by evaluation of objective response rate,tumour response, and overall survival
    Part A and B: Assess the pharmacodynamics of AZD4573 (in combination with acalabrutinib) and the pharmacodynamics of acalabrutinib (in combination with AZD4573)

    Assess biomarkers that may correlate with response and/or resistance to AZD4573/acalabrutinib
    Modulo 1
    Parte A e B: Valutare la farmacocinetica (PK) plasmatica/sierica di AZD4573 e di acalabrutinib (plus il suo metabolita attivo ACP-5862) quando vengono somministrati in combinazione

    Parte B: Valutare ulteriormente l’efficacia di AZD4573 in combinazione con acalabrutinib tramite la valutazione della risposta al tumore e del tasso di sopravvivenza totale
    Valutare la sicurezza e la tollerabilità della RP2D di AZD4573 in cominazione con acalabrutinib (100 mg BID)

    Esplorativi:
    Parte A: Valutare l’efficacia di AZD4573 in combinazione con acalabrutinib tramite la valutazione del tasso di risposta obiettiva, risposta al tumore e sopravvivenza complessiva
    Parte A e B: valutare la farmacodinamica di AZD4573 (in combinazione con acalabrutinib) e la farmacodinamica di acalabrutinib (in combinazione con AZD4573)

    Valutare i biomarcatori che potrebbero essere correlati con la risposta e/o la resistenza a AZD4573/acalabrutinib
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Genomics initiative research study (optional)

    Tumour biopsy at disease progression (optional)

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Genomics initiative research study (opzionale)

    Biopsia del Tumore durante la progressione della malattia (opzionale)
    E.3Principal inclusion criteria
    Patients must meet all the inclusion criteria of both the core and module protocol.
    Core
    1.Patients must be >= 18 years of age at the time of signing the informed consent.
    2.Eastern Cooperative Oncology Group (ECOG) performance status of <=2
    3.Documented active disease requiring treatment that is relapsed or refractory defined as:
    a.Recurrence of disease after response to at least one prior line(s) of therapy,or
    b.Progressive disease after completion of or on the treatment regimen preceding entry into the study or
    c. Disease that did not achieve an objective response (CR or PR).
    4. Adequate organ function at screening as defined in the protocol
    5. Uric acid level < upper limit of normal (ULN). If hyperuricaemia is present at screening, SoC therapy for hyperuricaemia should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.

    Module 1
    1.Patients must comply with the eligibility criteria described in Core module
    2. Patients with histologically confirmed r/r DLBCL or r/r MZL, for whom a clinical study is the best option (in the opinion of the investigator) for next treatment based on response and/or tolerability to prior lines of therapy.

    PLEASE REFER TO THE PROTOCOL FOR FUTHER INCLUSION CRITERIA
    I pazienti devono soddisfare tutti i criteri di inclusione sia del protocollo principale sia del protocollo relativo al modulo.
    Principali
    1. I pazienti devono avere compiuto almeno 18 anni di età al momento della firma del consenso informato.
    2. Stato di validità secondo l’Eastern Cooperative Oncology Group (ECOG) <=2.
    3. Malattia attiva documentata che richiede un trattamento recidivante o refrattario, definita come:
    a. Recidiva della malattia dopo la risposta ad almeno una precedente linea di terapia, oppure
    b. Progressione della malattia dopo il completamento o il regime di trattamento precedente all’ingresso nello studio o
    c. Malattia che non ha raggiunto una risposta obiettiva (risposta completa [CR] o risposta parziale [PR]).
    4. Adeguata funzionalità d’organo allo screening secondo i criteri definiti dal protocollo.
    5. Livello di acido urico < limite superiore della norma (ULN). Se l’iperuricemia è presente allo screening, deve essere somministrato lo standard di cura (SoC) per l’iperuricemia (compresi liquidi EV e rasburicase o allopurinolo) per ridurre i livelli di acido urico a < ULN prima dell’inizio del trattamento dello studio.

    Modulo 1
    1. I pazienti devono rispettare i criteri di eleggibilità descritti nel modulo principale
    2. Pazienti con linfoma diffuso a grandi cellule B recidivante o refrattario (r/r DLBCL) o linfoma della zona marginale recidivante o refrattario (r/r MZL) confermato istologicamente, per i quali uno studio clinico è l’opzione migliore (secondo il parere dello sperimentatore) per il trattamento successivo in base alla risposta e/o alla tollerabilità a precedenti linee di terapia.

    SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI INCLUSIONE
    E.4Principal exclusion criteria
    1. Patients with non-secretory myeloma
    2. Except alopecia, and neutropenia, unresolved non-haematological toxicities from prior therapy >CTCAE Grade 1 at study treatment start
    3. Presence or history of central nervous system (CNS) lymphoma, leptomeningeal disease or spinal cord compression
    4. Prior non-haematological malignancy except for the following:
    (a) Malignancy treated with curative intent with no evidence of active
    disease for >one year before screening and thought at low risk of
    recurrence by treating physician.
    (b) Adequately treated lentigo maligna melanoma without evidence of
    disease or adequately controlled non-melanomatous skin cancer.
    (c) Adequately treated carcinoma in situ without evidence of disease
    5. As judged by Investigator, severe or uncontrolled systemic disease (severe hepatic impairment, interstitial lung disease, unstable or uncompensated respiratory or cardiac conditions, uncontrolled hypertension, history of, or active, bleeding diatheses, uncontrolled active systemic infection or IV anti infective treatment within two weeks before first dose of study drug.
    6.Known history of infection with human immunodeficiency virus (HIV).
    7. Serologic status reflecting active hepatitis B or C infection:
    (a) Hepatitis B core antibody (anti-HBc) positive, surface antigen negative patients must have a negative polymerase chain reaction (PCR) result before enrolment. Hepatitis B surface antigen positive or hepatitis B PCR positive patients are excluded. (b) Hepatitis C antibody positive
    patients must have a negative PCR result before enrolment. Hepatitis C PCR positive patients are excluded.
    8. Any of the following cardiac criteria:
    (a) Resting QT interval corrected using Fridericia's formula (QTcF) >= 470 msec on a single ECG.
    (b) Any clinically important abnormalities in rhythm (excepting patients with a pacemaker), conduction or morphology of resting ECG.
    (c) Factors elevating the risk of QTc prolongation or arrhythmic events such as congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.
    Concomitant medications known to prolong QTc should be used with caution and cannot be used starting with the first dose of study drug and through the DLT assessment period (Part A) or during ECG assessments.

    PLEASE REFERO TO THE PROTOCOL FOR FURTHER EXCLUSION CRITERIA
    1. Pazienti con mieloma non secernente
    2. Fatta eccezione per l’alopecia e la neutropenia, tossicità non ematologiche non risolte dalla precedente terapia > grado 1 secondo i criteri terminologici comuni per gli eventi avversi (CTCAE) all’inizio del trattamento dello studio
    3. Presenza o anamnesi di linfoma del sistema nervoso centrale (SNC), malattia leptomeningea o compressione del midollo spinale
    4. Precedente neoplasia maligna non ematologica, fatta eccezione per quanto segue:
    (a) Neoplasia maligna trattata con intento curativo senza evidenza di malattia attiva per > un anno prima dello screening e ritenuta a basso rischio di recidiva dal medico curante.
    (b) Melanoma in lentigo maligna adeguatamente trattato, senza evidenza di malattia, o tumore della pelle non melanoma adeguatamente controllato.
    (c) Carcinoma in situ adeguatamente trattato, senza evidenza di malattia
    5. Secondo il giudizio dello sperimentatore, malattia sistemica grave o non controllata (insufficienza epatica grave, malattia polmonare interstiziale, condizioni respiratorie o cardiache instabili o non compensate, ipertensione non controllata, anamnesi o presenza di diatesi emorragica attiva, infezione sistemica attiva non controllata o trattamento antinfettivo EV nelle due settimane precedenti la prima dose del farmaco dello studio).
    6. Anamnesi nota di infezione da virus dell’immunodeficienza umana (HIV).
    7. Stato sierologico che riflette l’infezione attiva da epatite B o C:
    (a) I pazienti positivi agli anticorpi anti-core dell’epatite B (anti-HBc) e negativi all’antigene di superficie devono presentare un risultato negativo alla reazione a catena della polimerasi (PCR) prima dell’arruolamento. Sono esclusi i pazienti positivi all’antigene di superficie dell’epatite B o positivi alla PCR per l’epatite B. (b) I pazienti positivi agli anticorpi anti-epatite C devono presentare un risultato negativo alla PCR prima dell’arruolamento. Sono esclusi i pazienti positivi alla PCR per l’epatite C.
    8. Qualsiasi dei seguenti criteri cardiaci:
    (a) Intervallo QT a riposo corretto utilizzando la formula di Fridericia (QTcF) >= 470 msec su un singolo ECG.
    (b) Qualsiasi anomalia clinicamente importante nel ritmo (ad eccezione dei pazienti con pacemaker) nella conduzione o nella morfologia dell’ECG a riposo.
    (c) Fattori che aumentano il rischio di prolungamento del QTc o di eventi aritmici come sindrome congenita del QT lungo, anamnesi familiare di sindrome del QT lungo o morte improvvisa inspiegabile al di sotto dei 40 anni di età. I farmaci concomitanti noti per prolungare il QTc devono essere utilizzati con cautela e non possono essere utilizzati a partire dalla prima dose del farmaco dello studio e fino al periodo di valutazione delle tossicità limitanti la dose (DLT) (Parte A) o durante le valutazioni ECG.

    SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI CRITERI DI ESCLUSIONE
    E.5 End points
    E.5.1Primary end point(s)
    Part A
    •Adverse events
    •DLTs
    •Laboratory data
    •vital signs
    •ECG changes

    Part B
    •ORR- defined as the proportion of participants who have a tumor response (CR and PR).
    Parte A
    - Eventi avversi
    - DLTs
    -Dati di Laboratorio
    -segni vitali
    -cambiamenti ECG

    Parte B
    -ORR - definita come la percentuale di partecipanti aventi una risposta al tumore (CR e PR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    As detailed in the Schedule of Activities (SoA)
    Come dettagliato nella Scheda delle Attività (SoA)
    E.5.2Secondary end point(s)
    Part A and B
    •Plasma concentrations and derived PK parameters for AZD4573 summarized by cohort and dose level for the PK analysis set
    •Plasma concentrations and derived PK parameters for acalabrutinib and its metabolite ACP-5862 summarized by cohort and dose level for the PK analysis set

    Part B
    •Endpoints based on revised response criteria for malignant lymphoma:
    CR rate, DoR, TTR, PFS
    •OS
    •Adverse events, laboratory data, vital signs, and ECG changes
    Parte A e B
    •Concentrazioni plasmatiche e parametri PK derivati per AZD4573 riassunti per coorte e livello di dosaggio per la serie di analisi PK
    •Concentrazioni plasmatiche/sieriche e parametri PK derivati per acalabrutinib e il suo metabolita ACP-5862 riassunti per coorte e livello di dosaggio per la serie di analisi PK

    Parte B
    Endpoints basati sui criteri di risposta rivisti per il linfoma maligno:
    CR rate, DoR, TTR, PFS
    •OS
    •Eventi avversi, dati di laboratorio, segni vitali e variazioni nell’ECG
    E.5.2.1Timepoint(s) of evaluation of this end point
    As detailed in the Schedule of Activities (SoA)
    Come dettagliato nella Scheda delle Attività (SoA)
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, MTD maximum tolerated dose, DLT dose-limiting toxicity, RP2D recommended Phase II dose
    Tollerabilità, massima dose tollerata MTD, Tossicità DLT dose-limitante, Dose RP2D raccomandata Fase II
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Modular Phase I/II
    Modulare Fase I/II
    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 Yes
    E.8.1.7.1Other trial design description
    Modulare
    Modular
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Canada
    Korea, Republic of
    United States
    France
    Ireland
    Italy
    Poland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    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: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with incurrable diseases
    Pazienti con malattie incurabili
    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 63
    F.4.2.2In the whole clinical trial 78
    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 Decision2022-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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