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    Summary
    EudraCT Number:2020-005078-82
    Sponsor's Protocol Code Number:LIBImAB
    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:2021-06-07
    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 number2020-005078-82
    A.3Full title of the trial
    Phase III study in mCRC patients with RAS/BRAF wild type tissue and RAS mutated in LIquid BIopsy to compare in first-line therapy FOLFIRI plus CetuximAb or BevacizumAb
    Studio di fase III in pazienti con tumore del colon-retto metastatico, RAS/BRAF wild type sul tessuto tumorale e RAS mutato su biopsia liquida con l’obiettivo di confrontare una terapia di prima linea con schema FOLFIRI in associazione a cetuximab o bevacizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III study in patients with colorectal cancer RAS/BRAF un mutated on the tumor tissue and RAS mutated in liquid biopsy with the aim of comparing a FOLFIRI therapy in combination with cetuximab or bevacizumab.
    Studio di fase III in pazienti con diagnosi di tumore del colon-retto in presenza di RAS/BRAF non mutato sul tessuto del tumore e RAS mutato sulla biopsia liquida con l'obiettivo di confrontare una terapia con schema FOLFIRI in associazione al farmaco cetuximab o bevacizumab.
    A.3.2Name or abbreviated title of the trial where available
    LIBImAb
    LIBImAb
    A.4.1Sponsor's protocol code numberLIBImAB
    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 SponsorAZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAIFA - Italian Medicines Agency
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche Mario Negri IRCCS
    B.5.2Functional name of contact pointLaboratorio di Metodologie per la R
    B.5.3 Address:
    B.5.3.1Street AddressVia Mario Negri,2
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014681
    B.5.5Fax number0233200231
    B.5.6E-maillibimab@marionegri.it
    D. IMP Identification
    D.IMP: 1
    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 Erbitux
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCetuximab
    D.3.2Product code [Cetuximab]
    D.3.4Pharmaceutical form 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.1.1.1Trade name AVASTIN
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBEVACIZUMAB
    D.3.2Product code [BEVACIZUMAB]
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Patients with metastatic colorectal cancer RAS/BRAF wild type not previously treated in metastatic setting
    Pazienti con tumore del colon-retto metastatico (mCRC)RAS/BRAF wild type non precedentemente trattati per malattia metastatica.
    E.1.1.1Medical condition in easily understood language
    Patients with mestatic colorectal cancer diagnosis with RAS/BRAF not mutated and never treated for metastatic disease
    Pazienti con diagnosi di tumore metastatico al colon-retto con RAS/BRAF non mutato mai trattati precedentemente per malattia mestatica
    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 SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10010023
    E.1.2Term Colorectal neoplasms malignant
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess whether the combination of bevacizumab plus chemotherapy is superior to cetuximab plus chemotherapy in terms of progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue.
    L'obiettivo primario dello studio è quello di valutare se in pazienti con mCRC RAS mutato su biopsia liquida e RAS WT su tessuto una terapia di prima linea con schema FOLFIRI in associazione a bevacizumab sia superiore rispetto alla stessa terapia di prima linea con schema FOLFIRI in associazione a cetuximab, in termini di sopravvivenza libera da progressione (PFS).
    E.2.2Secondary objectives of the trial
    - to assess whether the combination of bevacizumab plus chemotherapy is superior to
    cetuximab plus chemotherapy in terms of Overall survival (OS)
    - to assess whether the combination of bevacizumab plus chemotherapy is superior to
    cetuximab plus chemotherapy in terms of Objective response rate (ORR)
    - to describe the prevalence of mutation of RAS evaluated at liquid biopsy in a population of
    mCRC with RAS wild type on tumor tissue
    - to describe the safety of the two treatment arms
    - to describe the compliance of the two treatment arms
    - valutare se l’associazione bevacizumab e chemioterapia sia superiore all’associazione chemioterapia e cetuximab in termini di sopravvivenza complessiva (OS)
    - valutare se l’associazione bevacizumab e chemioterapia sia superiore all’associazione chemioterapia e cetuximab sia superiore in termini di tasso di risposte obiettive
    (ORR)
    - descrivere la prevalenza della mutazione di RAS valutata su biopsia liquida in una popolazione mCRC RAS WT su tessuto tumorale
    - descrivere la safety dei due bracci di trattamento. Gli eventi avversi (AE) saranno descritti utilizzando termini MedDRA (versione 20.0) e classificati secondo l’NCI-CTCAE
    versione 5.0
    - descrivere la compliance dei due bracci di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent;
    2. Male or female > 18 years of age;
    3. Histologically confirmed diagnosis of colorectal adenocarcinoma RAS/BRAF wild type (analysed either on primary and/or related metastasis);
    4. Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
    5. Patient with left colorectal cancer;
    6. Patients suitable for first line chemotherapy;
    7. Life expectancy > 3 months;
    8. At least one site of measurable disease per RECIST criteria ver. 1.1;
    9. ECOG Performance status = 2;
    10. Adequate bone marrow, liver and renal function assessed before starting study treatment;
    11. If DPD status is known it must be wild type. No restrictions are applied if DPD status in unknown;
    12.Women of childbearing potential must have a negative blood pregnancy test within 24 hr prior to the start of study treatment.
    For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive.
    13. Subjects and their partners must be willing to avoid pregnancy during the trial and until 5 months for WOCBP (Women of Childbearing Potential) and 7 months for male subjects with female partners of WOCBP after the last trial treatment. Male
    subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to
    use adequate contraception as approved by the investigator (barriers contraceptive measure or oral contraception).
    1. Consenso informato scritto.
    2. Età superiore a 18 anni.
    3. Diagnosi di tumore del colon-retto confermata istologicamente RAS/BRAF wild-type (metastasi primaria e/o correlata).
    4. Tumore del colon-retto metastatico non candidabile alla chirurgia e non trattato in precedenza con chemioterapia per malattia metastatica.
    5. Pazienti con tumore del colon-retto sinistro.6. Pazienti candidabili a una chemioterapia di prima linea.
    7. Aspettativa di vita > 3 mesi.
    8. Presenza di almeno una lesione misurabile in accordo ai criteri RECIST (Solid Tumors) versione 1.1
    9. ECOG Performance status = 2
    10. Pazienti con adeguate funzionalità del midollo osseo, epatiche e renali valutate prima di iniziare il trattamento in studio
    11. Se lo stato diidropirimidina deidrogenasi (DPD) è noto, deve essere wild type. Nessuna restrizione viene applicata se lo stato DPD è non noto.
    12. Le donne potenzialmente fertili devono avere un test di gravidanza negativo entro 24 ore prima dell'inizio del trattamento in studio. Per questa sperimentazione, sono definite potenzialmente fertili tutte le donne dopo la pubertà, a meno che non siano in postmenopausa per almeno 12 mesi, chirurgicamente sterili o siano sessualmente inattive.
    13. I pazienti e i loro partner devono essere disposti ad evitare una gravidanza durante lo studio e fino a 5 mesi per WOCBP (Women of Childbearing Potential) o fino a 7 mesi per i soggetti maschi con partner WOCBP dopo l'ultimo trattamento in studio. I pazienti maschi con partner femminili potenzialmente fertili e pazienti di sesso femminile potenzialmente fertili devono, pertanto, essere disposti a utilizzare un metodo contraccettivo adeguato e approvato dallo sperimentatore (misure contraccettive o contraccezione orale).
    E.4Principal exclusion criteria
    1. Previous chemotherapy treatment, with the exception of patient treated in adjuvant setting completed at least 6 months before
    the randomization;
    2. Any contraindication to the use of Cetuximab, Bevacizumab, Irinotecan, 5FU or folinic acid;
    3. Radiotherapy to any site within 4 weeks before the randomization;
    4. Serious, non-healing wound, ulcer, or bone fracture;
    5. Evidence of bleeding diathesis or coagulopathy;
    6. Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy;
    7. Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
    skin, or in situ cervical cancer that has undergone potentially curative therapy;
    8. Active and untreated brain (CNS) metastases and/or carcinomatous meningitis;
    9. Active infection requiring systemic therapy or active disseminated intravascular coagulation;
    10. History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antobodies);
    11. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection;
    12. Chronic, daily treatment with high-dose aspirin (>325 mg/day);
    13. Any previous venous thromboembolism > NCI CTCAE Grade 3;
    14. History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first
    study treatment. History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea;
    15. Current, recent (within 10 days prior to study treatment start) or ongoing treatment with anticoagulants for therapeutic
    purposes;
    16.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or
    anticipation of the need for major surgical procedure during the course of the study;
    17. History of any severe hypersensitivity reactions to any monoclonal antibody;
    18. A significant concomitant disease which, in the investigating physician's opinion, rules out the patient’s participation in the
    study
    1. Chemioterapia preventiva, ad eccezione di un trattamento adiuvante completato almeno 6 mesi prima rispetto alla randomizzazione.
    2. Qualsiasi controindicazione all'uso di Cetuximab, Bevacizumab, Irinotecan, 5FU o acido folinico.
    3. Radioterapia in qualsiasi sede entro 4 settimane prima della randomizzazione.
    4. Ferite croniche serie, non guaribili, ulcere e fratture ossee.
    5. Evidenza di diatesi emorragica o coagulopatia.
    6. Ipertensione incontrollata e storia precedente di crisi ipertensiva o encefalopatia ipertensiva.
    7. Altri tumori maligni negli ultimi 5 anni, ad eccezione del carcinoma cutaneo non melanoma, cancro della cervice in situ adeguatamente trattati.
    8. Metastasi cerebrali attive e non trattate (SNC) e/o meningite carcinomatosa.
    9. Infezione attiva che richiede una terapia sistemica o una coagulazione intravascolare diffusa attiva
    10. Storia del virus dell'immunodeficienza umana (HIV) (anticorpi HIV 1/2).
    11. Test positivo per il virus dell'epatite B o dell'epatite C che indichi un'infezione acuta o cronica.
    12. Trattamento cronico e quotidiano con aspirina ad alta dose (>325 mg/giorno).
    13. Evidenza di tromboembolismo venoso precedente > Grado 3. Secondo la classificazione NCI -CTCAE
    14. Storia di fistola addominale, perforazione gastrointestinale (GI), ascesso intra-addominale o sanguinamento GI attivo nei 6 mesi precedenti al primo trattamento di studio. Storia di occlusione intestinale acuta o subacuta o malattia infiammatoria cronica intestinale o diarrea cronica.
    15. Trattamento in corso (nei 10 giorni precedenti all'inizio del trattamento in studio) con anticoagulanti per scopi terapeutici.
    16. Procedura chirurgica importante, biopsia aperta o lesioni traumatiche significative nei 28 giorni precedenti all'inizio del trattamento in studio, o anticipazione della necessità di una procedura chirurgica importante durante il corso dello studio.
    17. Storia di eventuali reazioni di ipersensibilità grave a qualsiasi anticorpo monoclonale.
    18. Qualsiasi malattia concomitante significativa che, secondo il medico responsabile, esclude la partecipazione del paziente nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be progression free survival (PFS).
    - Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From patient randomization until progression, lost to follow-up, consent withdrawal, death, based on investigator assessment determined by RECIST (version v1.1).
    Dalla randomizzazione del paziente fino alla progressione, ritiro del consenso, perso al follow-up, morte valutata secondo RECIST (Solid Tumors) (versione 1.1)
    E.5.2Secondary end point(s)
    Overall survival; Objective Response Rate (ORR); Prevalence of RAS mutation; Safety; Compliance
    Sopravvivenza complessiva; Tasso di risposta oggettivo (ORR); Prevalenza di mutazione RAS; Sicurezza; Aderenza al trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival (OS) defined as the time from start of treatment to the date of death for any cause
    or, for living patients, the date of last contact.; Objective Response Rate (ORR), defined as the percentage of patients with a complete (CR) or
    partial response (PR) as best response during treatment as determined by RECIST 1.1.; Percentage of RAS mut patients on the total of patients who undergone to liquid biopsy at the first
    and second evaluations.; The maximum toxicity grade experienced by each patient, for each toxicity, according to NCI CTCAE
    v. 5.0; the number of patients experiencing grade 3-4 toxicity for each toxicity; type,
    frequency and nature of SAEs; patients with at least a SAE; patients with at least a SADR; patients
    with at least a SUSAR.; The compliance to treatment will
    OS definito come il tempo dall'inizio del trattamento fino alla data di morte per qualsiasi causa o per pazienti in vita, la data dell'ultimo contatto.; ORR definito come percentuale di pazienti con una risposta completa (CR) o parziale (PR), in risposta migliore durante il trattamento secondo i criteri RECIST v. 1.1; Percentuale di pazienti con RAS mutato sul totale dei pazienti sottoposti a biopsia liquida alla prima o alla seconda valutazione.; Definita come il massimo grado di tossicità sperimentato da ciascun paziente, per ogni tossicità; secondo NCI CTCAE versione 5.0; il numero di pazienti che sperimentano tossicità di grado 3-4 per ciascuna tossicità; tipo, frequenza e natura delle SAE; pazienti con almeno una SAE; pazienti con almeno una SADR; pazienti con almeno una SUSAR.;
    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 No
    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 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 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 concerned73
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 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 state280
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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 end of the treatment visit should occur within 30 days after last dose of study treatment is administered. At the conclusion of treatment, the doctor will ask to patients to repeat some necessary examinations to assess the state of the disease and health conditions. In addition, the patients will be made some periodic visits after the end of the treatment. These visits will be made on a scheduled basis (every 3 months for a year) to evaluate the patient's health after treatment.
    Dopo la conclusione del trattamento il medico responsabile chiederà di ripetere alcuni esami necessari per valutare lo stato della malattia e le condizioni di salute.
    Inoltre verranno effettuate alcune visite periodiche successive alla fine del trattamento. Queste visite (chiamate di follow-up) saranno effettuate con cadenza
    programmata (ogni 3 mesi circa per un anno) e hanno lo scopo di valutare la salute del paziente dopo il trattamento.
    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 Decision2021-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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