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    Summary
    EudraCT Number:2017-004157-16
    Sponsor's Protocol Code Number:CABinMET
    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:2021-09-10
    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 number2017-004157-16
    A.3Full title of the trial
    Phase II single arm study with CABozantinib in Non-Small Cell Lung Cancer patients with MET deregulation
    Studio di fase II a singolo braccio con cabozantinib in pazienti con carcinoma polmonare non a piccole cellule con deregolazione di MET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II single arm study with CABozantinib in Non-Small Cell Lung Cancer patients with MET deregulation
    Studio di fase II a singolo braccio con cabozantinib in pazienti con carcinoma polmonare non a piccole cellule con deregolazione di MET
    A.3.2Name or abbreviated title of the trial where available
    CABinMET
    CABinMET
    A.4.1Sponsor's protocol code numberCABinMET
    A.5.4Other Identifiers
    Name:CABinMETNumber:CABinMET
    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 SponsorFONDAZIONE RICERCA TRASLAZIONALE (FORT)
    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 supportIPSEN S.P.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo, snc- trav. Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089-301545
    B.5.5Fax number089-7724155
    B.5.6E-mailcabinmet@cr-technology.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 CABOMETYX - 60 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    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 nameCABOZANTINIB
    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 INNCABOZANTINIB
    D.3.9.1CAS number 1140909-45-3
    D.3.9.2Current sponsor codeCABOZANTINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.3.11.13.1Other medicinal product typeSINTESI CHIMICA
    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 CABOMETYX - 40 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    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 nameCABOZANTINIB
    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 INNCabozantinib
    D.3.9.1CAS number 1140909-45-3
    D.3.9.2Current sponsor codeCabozantinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typesintesi chimica
    D.IMP: 3
    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 CABOMETYX - 20 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA
    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 nameCabozantinib
    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 INNCabozantinib
    D.3.9.1CAS number 1140909-45-3
    D.3.9.2Current sponsor codeCabozantinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeSINTESI CHIMICA
    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
    Stage III B or stage IV non-small cell lung cancer (not a candidate for local therapies with curative intent)
    Carcinoma polmonare non a piccole cellule di stadio III B (non candidabile a terapie locali con intento curativo) o di stadio IV
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Lung Cancer
    Tumore al polmone non a piccole cellule
    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 PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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 evaluate the efficacy in term of response rate (RR) of Cabozantinib in NSCLC patients with MET amplification or MET exon 14 skipping mutation pretreated or not with MET inhibitors.
    Valutare l'efficacia in termini di Response Rate (RR) del Cabozantinib in una coorte di pazienti NSCLC con amplificazione di MET o con mutazione attivante di MET a carico dell'esone 14, pre-trattati o no con inibitori di MET
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Citological or histological diagnosis of NSCLC non-small-cell-lung cancer (NSCLC) stage III B (notn suitable for local treatments with curative intent) or stage IV.
    2. Tissue samples available for MET analysis (archivial tissue or tissue collected at study entry); patients without archival tumor tissue or refusing new biopsy at study entry, are eligible if MET mutation is detected in cf-DNA
    3. Presence of MET mutations (exon 14 skipping mutation ONLY) detected in tissue or cf-DNA at the local lab or in the central lab or MET amplification (MET/CEP7 ratio > 2.2) detected in the central lab ONLY.
    4. Measurable disease according to RECIST criteria version 1.1
    5. At least 1 prior line of standard therapy (chemotherapy and/ or immunotherapy)
    6. Performance status 0-1 (ECOG)
    7. Age =18 years
    8. Patients potentially fertile using adequate methods of contraception in order to avoid childbearing. Contraceptive methods must be respected by male and female patients and their partners during study treatment period and at least 4 months after completing therapy
    9. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to enrollment: 7.a. ANC = 1500 cells/µL without granulocyte colony-stimulating factor support 8.b. Platelet count = 100,000/µL without transfusion 9.c. Hemoglobin = 9.0 g/dL
    Patients may be transfused to meet this criterion
    d. AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions:
    - Patients with documented liver metastases: AST and/or ALT = 5 × ULN
    Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN.
    e. Serum bilirubin = 1.25 × ULN
    f. Patients with known Gilbert disease who have serum bilirubin level = 3 × ULN may be enrolled
    g. Calculated creatinine clearance (CRCL) = 45 mL/min or, if using cisplatin, calculated CRCL must be = 60 mL/min
    10. Patient compliance to the study procedure
    11. Written informed consent
    1. Diagnosi citologica o istologica di carcinoma polmonare non a piccole cellule (NSCLC) di stadio III B (non candidabile a terapie locali con intento curativo) o di stadio IV
    2. Disponibilità di campione di tessuto per le analisi di MET (tessuto di archivio o tessuto fresco raccolto all’ingresso nello studio); i pazienti per i quali non sia disponibile tessuto tumorale di archivio o che rifiutino di sottoporsi alla biopsia all’arruolamento, sono eleggibili se la mutazione di MET è rilevata nel cf-DNA
    3. Presenza di mutazioni di MET (solo skipping mutation di MET a carico dell’esone 14) rilevate in tessuto o cf-DNA nel laboratorio locale o nel laboratorio centralizzato o amplificazione di MET (MET/CEP7 ratio> 2.2) rilevata esclusivamente presso il laboratorio centralizzato
    4. Malattia misurabile in accordo ai criteri RECIST versione 1.1
    5. Almeno 1 linea precedente di terapia standard (chemioterapia e/o immunoterapia)
    6. Performance status 0-1 (ECOG)
    7. Età =18 anni
    8. Pazienti potenzialmente fertili che usano adeguati metodi di contraccezione allo scopo di evitare gravidanze. I metodi contraccettivi devono essere rispettati da pazienti di sesso maschile e femminile e dai loro partner durante il periodo di trattamento sperimentale ed almeno fino a 4 mesi dopo il completamento della terapia
    9. Adeguata funzionalità ematologica e d’organo, definita dai seguenti esami di laboratorio ottenuti entro 14 giorni precedenti l’arruolamento:
    a. ANC = 1500 cell/ µL in assenza di supporto del fattore stimolante la colonia di granulociti
    b. Conta piastrinica = 100,000/µL in assenza di trasfusione
    c. Emoglobina = 9.0 g/dL
    I pazienti possono essere trasfusi per soddisfare questo criterio
    d. AST, ALT, e fosfatasi alcalina = 2.5 × ULN, con le seguenti eccezioni:
    -pazienti con metastasi al fegato documentate: AST e/o ALT = 5 × ULN
    -pazienti con metastasi al fegato o alle ossa: fosfatasi alcalina = 5 × ULN
    e. Bilirubina sierica = 1.25 × ULN
    f. Pazienti con Sindrome di Gilbert nota che hanno livelli di bilirubina sierica = 3 × ULN possono essere arruolati
    g. Clearance della creatinina calcolata (CRCL) = 45 mL/min o la CRCL calcolata deve essere = 60 mL/min
    10. Compliance del paziente alle procedure di studio
    11. Consenso informato scritto
    E.4Principal exclusion criteria
    1. Tissue sample not available in patients without MET exon 14 skipping mutation detected in cf-DNA
    2. No possibility to assess MET status
    3. Absence of any measurable disease according to RECIST criteria
    4. Co-existence of driver events, including EGFR mutations, KRAS mutations, ALK rearrangements or ROS-1 rearrangements
    5. No prior therapy
    6. Concomitant chemotherapy or immunotherapy or radiotherapy
    7. Symptomatic brain metastasis
    8. Uncontrolled significant inter-current or recent illness, including cardio-vascular disorders and gastro-intestinal disorders
    9. Major surgery within 2 months before first dose of study treatment
    10. Concomitant anti-coagulation with oral anti-coagulants or plated inhibitors
    11. History of significant bleeding, trachea-bronchial tree/major blood vessels invading tumors, cavity pulmonary lesions and GI disorders associated with a risk of perforation or fistula formation
    12. Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basalioid)
    13. Pregnancy or breastfeeding
    1. Tessuto non disponibile in pazienti nei quali non sia stata rilevata una skipping mutation di MET a carico dell’esone 14 nel cf-DNA
    2. Nessuna possibilità di valutare lo status di MET
    3. Assenza di malattia misurabile in accordo ai criteri RECIST
    4. Concomitanza di eventi “driver”, incluse mutazioni EGFR, mutazioni KRAS, riarrangiamenti di ALK o ROS-1
    5. Nessuna terapia precedente
    6. Concomitante chemioterapia o immunoterapia o radioterapia
    7. Metastasi all’encefalo sintomatiche
    8. Malattia significativa incontrollata intercorrente o recente, inclusi disordini cardio-vascolari e gastro-intestinali
    9. Chirurgia maggiore entro 2 mesi precedenti alla prima dose del trattamento di studio
    10. Terapia concomitante con anti- coagulanti orali o antiaggregante piastrinica
    11. Storia di emorragia significativa, tumori invasivi dei principali vasi sanguigni tracheobronchiali, lesioni alla cavità polmonare e disordini gastrointestinali associati a rischio di perforazione o di formazione di fistole
    12. Diagnosi di un altro tumore negli ultimi 3 anni, eccetto carcinoma in situ della cervice, mammella e vescica o carcinoma della pelle (squamoso o basalioma)
    13. Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Response Rate (RR) (complete + partial responses) of Cabozantinib in NSCLC patients with MET amplification or MET exon 14 skipping mutation pre-treated or not with MET inhibitors.
    Response Rate (RR) (completa + risposta parziale) di Cabozantinib in pazienti NSCLC con amplificazione di MET o con skipping mutation di MET a carico dell’esone 14 pre-trattati o no con inibitori di MET
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease evaluation will be performed according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. every two months (8 weeks) until disease progression, unacceptable toxicity or patient refusal
    La valutazione di malattia sarà effettuata in accordo ai criteri RECIST 1.1 ogni 2 mesi (8 settimane) fino a progressione di malattia, tossicità inaccettabile o rifiuto del paziente
    E.5.2Secondary end point(s)
    Progression free survival (PFS)
    - Overall survival (OS)
    - Disease Control Rate (DCR: malattia stabile + risposta parziale + risposta completa)
    - Biomarkers esploratori su sangue o tessuto (per ogni paziente arruolato nello studio potrà essere facoltativamente donato un campione di tessuto alla progressione di malattia)
    - Progression free survival (PFS)
    - Overall survival (OS)
    - Disease Control Rate (DCR: stable disease + partial response + complete response)
    - Exploratory biomarkers on blood and tissue samples (for each patient enrolled in the study optionally a tissue sample could be provided at disease progression)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease evaluation will be performed according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. every two months (8 weeks) until disease progression, unacceptable toxicity or patient refusal
    La valutazione di malattia sarà effettuata in accordo ai criteri RECIST 1.1 ogni 2 mesi (8 settimane) fino a progressione di malattia, tossicità inaccettabile o rifiuto del paziente
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned21
    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 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
    Enrolment duration: 24 months
    Follow-up duration: at least 12 months
    Durata dell’arruolamento: 24 mesi
    Durata del Follow-up: almeno 12 mesi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned 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 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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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)
    Patients who are going out of the study will be followed in a short-term follow-up (30 days after the end of treatment) and in the long term (every three months after the end of treatment) during which they will be followed for any adverse events, to new anticancer therapies and to monitoring the progression of the disease
    I pazienti usciti dallo studio saranno seguiti in un follow-up a breve termine (30 giorni dopo la fine del trattamento) e a lungo termine (ogni tre mesi dopo la fine del trattamento) durante i quali saranno seguiti in merito agli eventuali eventi avversi, alle nuove eventuali terapie anticancro e al monitoraggio della progressione di malattia
    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 Decision2018-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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