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    Summary
    EudraCT Number:2019-001388-55
    Sponsor's Protocol Code Number:CAPT
    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:2021-05-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001388-55
    A.3Full title of the trial
    A Phase II Trial of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic Triple-negative PD-L1 positive breast cancer patients
    Studio Clinico di fase II con atezolizumab in associazione con carboplatin e paclitaxel come terapia di prima linea in pazienti con carcinoma mammario metastatico Triplo-negativo PD-L1 positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Trial of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic Triple-negative PD-L1 positive breast cancer patients
    Sperimentazione clinica di fase 2 che coinvolge pazienti affetti da un sottotipo di carcinoma mammario metastatico definito come triplo negativo e PD-L1 positivo
    A.3.2Name or abbreviated title of the trial where available
    GIM 25 - CAPT
    GIM 25 - CAPT
    A.4.1Sponsor's protocol code numberCAPT
    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 SponsorCONSORZIO ONCOTECH
    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 supportRoche spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology Srl
    B.5.2Functional name of contact pointProject management
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo Traversa Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailcapt@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 No
    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 nameAtezolizumab
    D.3.2Product code [RO554-1267]
    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 INNatezolizumab
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO554-1267, MPDL3280A
    D.3.9.3Other descriptive namehuman immunoglobulin G1 (IgG1) monoclonal antibody
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Metastatic Triple-negative PD-L1 positive breast cancer
    Carcinoma mammario metastatico Triplo-negativo PD-L1 positivo
    E.1.1.1Medical condition in easily understood language
    metastatic Triple-negative PD-L1 positive breast cancer
    carcinoma mammario metastatico PD-L1 positivo e particolarmente difficile da trattare
    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 10073100
    E.1.2Term Metaplastic breast carcinoma
    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 provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients as evaluated by % 2years OS.
    L’Obiettivo primario è di fornire evidenze preliminari sull’efficacia di atezolizumab in associazione con carboplatino e paclitaxel come terapia di prima linea in pazienti con carcinoma mammario metastatico triplo-negativo PD-L1 positivo valutata come % OS a 2 anni
    E.2.2Secondary objectives of the trial
    • To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in terms of % OS at 2.5 years
    • To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in terms of % OS at 2 years in hormonal receptor (HR) between 1% and 10%
    • To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in terms of post-progression survival
    • To assess the activity of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in terms of ORR, and time to treatment failure
    • To assess the safety of atezolizumab plus carboplatin plus paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients
    • Fornire dati preliminari sull’efficacia di atezolizumab in associazione con carboplatino e paclitaxel come terapia di prima linea in termini di % di OS a 2,5 anni
    • Fornire dati preliminari sull’efficacia di atezolizumab in associazione con carboplatino e paclitaxel come terapia di prima linea in termini di % di OS a 2 anni in recettori ormonali (HR) tra 1% e 10%
    • Fornire dati preliminari sull’efficacia di atezolizumab in associazione con carboplatino e paclitaxel come terapia di prima linea in termini di sopravvivenza post-progressione
    • Valutare l’attività di atezolizumab in associazione con carboplatino e paclitaxel come terapia di prima linea in termini di ORR e tempo al fallimento del trattamento
    • Valutare la sicurezza di atezolizumab associato a carboplatino e paclitaxel come terapia di prima linea in pazienti con carcinoma mammario metastatico triplo-negativo PD-L1 positivo
    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: Version 1.0 Date: 20 November 2019

    - Variation of ctDNA levels from baseline to first evaluation through the multigene FoundationOne® Liquid NGS panel
    - Variation of ctDNA levels from the first evaluation to progression through the multigene FoundationOne® Liquid NGS panel
    - Association between archival PD-L1 levels and target genes expression levels through CLIO analysis
    - Variation of target genes expression levels through CLIO analysis from baseline to first evaluation
    - Variation of target genes expression levels through CLIO analysis from first evaluation to disease progression

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Versione 1.0 Data: 20 Novembre 2019

    - Variazione dei livelli di ctDNA alla prima valutazione rispetto al baseline attraverso il test multigene FoundationOne® Liquid NGS panel
    - Variazione dei livelli di ctDNA alla progressione di malattia rispetto alla prima valutazione attraverso il test multigene FoundationOne® Liquid NGS panel
    - Associazione tra i livelli di PD-L1 da archivio ed i livelli di espressione dei geni target attraverso l'analisi CLIO
    - Variazione dei livelli di espressione dei geni target alla prima valutazione rispetto al baseline attraverso l'analisi CLIO
    - Variazione dei livelli di espressione dei geni target alla progressione di malattia rispetto alla prima valutazione attraverso l'analisi CLIO
    E.3Principal inclusion criteria
    1. Signed Informed Consent Form
    2. Women or men aged =18 years
    3. Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic disease
    4. Hormone receptor-negative (ER and PgR < 10%) and HER2-negative (IHC 0,1+ or 2+ ISH not amplified) breast cancer, based on the status of the primary tumor and/or the biopsy of metastatic disease before starting first-line therapy and assessed by local laboratory.
    5. PD-L1 positive defined as expression on tumor-infiltrating immune cells =1% (SP142 PD-L1 immunohistochemical assay, Ventana Medical Systems), based on the status of the primary tumor and/or the biopsy of metastatic disease before starting first-line therapy and assessed by local laboratory
    6. Availability of a representative tumor specimen for translational research
    7. Eligible for first-line taxane and carboplatin chemotherapy
    8. No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC. Prior radiation therapy for metastatic disease is permitted. There is no required minimum washout period for radiation therapy; however, patients should have recovered from the effects of radiation before enrollment
    9. Previous chemotherapy with taxanes and/or carboplatin for early breast cancer (neoadjuvant or adjuvant setting) is permitted if completed =12 months before study entry
    10. Previous therapy with immune checkpoint inhibitors for early breast cancer (neoadjuvant or adjuvant setting) is permitted if completed =12 months before study entry
    11. ECOG performance status of 0 or 1
    12. Life expectancy = 12 weeks
    13. Measurable or evaluable disease as defined by RECIST v1.1.
    14. Adequate hematologic and end-organ function, defined by laboratory results obtained within 2 weeks prior to the first study treatment (Cycle 1, Day 1)
    15. Negative human immunodeficiency virus (HIV) test at screening
    16. Negative hepatitis B surface antigen (HBsAg) test at screening
    17. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test
    18. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test
    19. Women of child bearing potential must agree to either use a contraceptive method with a failure rate of = 1% per year or to remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 5 months after the last dose of atezolizumab, or for at least 6 months after the last dose of paclitaxel. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of = 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
    20. Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
    21. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
    1. Firma del Consenso Informato
    2. Donne o uomini di età =18 anni
    3. Adenocarcinoma mammario istologicamente o citologicamente confermato con malattia metastatica
    4. Carcinoma mammario recettore-negativo (ER e PgR <10%) e HER2-negativo (IHC 0,1+ o 2+ ISH non amplificato), basato sullo stato del tumore primario e/o sulla biopsia della malattia metastatica prima di iniziare la terapia di prima linea e valutata dal laboratorio locale
    5. Positività di PD-L1, definita come espressione sulle cellule immunitarie infiltranti il tumore =1% (valutata attraverso il saggio immunoistochimico PD-L1, SP142, Ventana Medical Systems), sulla base dello stato del tumore primario e/o della biopsia sulla malattia metastatica precedente l’inizio della terapia di prima linea e valutata dal laboratorio locale
    6. Disponibilità di un campione tumorale per la ricerca traslazionale
    7. Idoneità alla chemioterapia di prima linea con taxani e carboplatino
    8. Nessuna chemioterapia precedente o terapia sistemica target (compresa la terapia endocrina) per TNBC localmente avanzato o metastatico non operabile. È consentita precedente radioterapia per la malattia metastatica. Non è richiesto un periodo di washout minimo per la radioterapia; tuttavia, i pazienti dovrebbero riprendersi dagli effetti delle radiazioni prima dell'arruolamento
    9. Chemioterapia precedente con taxani e/o carboplatino per carcinoma mammario in fase iniziale (setting neoadiuvante o adiuvante) è consentita se completata =12 mesi prima dell'ingresso nello studio
    10. Terapia precedente con inibitori del checkpoint immunitario per carcinoma mammario in fase iniziale (setting neoadiuvante o adiuvante) è consentita se completata =12 mesi prima dell'ingresso nello studio
    11. ECOG performance status 0 o 1
    12. Aspettativa di vita = 12 settimane
    13. Malattia misurabile o valutabile in base ai criteri RECIST v1.1.
    14. Funzionalità ematologiche e degli organi target adeguate, definite dai risultati di laboratorio ottenuti entro 2 settimane prima del primo trattamento dello studio (Ciclo 1, Giorno 1)
    15. Negatività al test del virus dell'immunodeficienza umana (HIV) eseguito allo screening
    16. Negatività al test dell'antigene di superficie dell'epatite B (HBsAg) eseguito allo screening
    17. Negatività al test sugli anticorpi in forma totale anti-core per l'epatite B (HBcAb) eseguito allo screening o test HBcAb positivo seguito da un test negativo del DNA del virus dell'epatite B (HBV) allo screening. Il test del DNA dell'HBV verrà eseguito solo per i pazienti che hanno un test HBcAb positivo
    18. Negatività al Test sugli anticorpi per il virus dell'epatite C (HCV) allo screening o test positivo sugli anticorpi HCV seguito da un test negativo su HCV RNA allo screening. Il test su HCV RNA verrà eseguito solo per i pazienti che hanno un test positivo all’anticorpo HCV
    19. Le donne in età fertile devono utilizzare un metodo contraccettivo con un tasso di fallimento = 1% per anno o praticare astinenza (da rapporti eterosessuali) durante il periodo di trattamento e per almeno 5 mesi dopo l'ultima dose di atezolizumab o per almeno 6 mesi dopo l'ultima dose di paclitaxel.
    20. Le donne in età fertile devono presentare un risultato negativo del test sierico di gravidanza entro 7 giorni precedenti l'inizio del trattamento col farmaco in studio
    21. Per gli uomini: praticare astinenza (dal rapporto eterosessuale) o usare metodi contraccettivi e astenersi dalla donazione di sperma.
    E.4Principal exclusion criteria
    1. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to enrollment.
    2. Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases, provided all of the following criteria are met:
    3. Uncontrolled pleural effusion, pericardial effusion, or ascites
    4. Uncontrolled tumor-related pain
    5. Uncontrolled hypercalcemia (>1.5 mmol/L [>6 mg/dL] ionized calcium or serum calcium [uncorrected for albumin] >3 mmol/L [>12 mg/dL] or corrected serum calcium >ULN) or clinically significant (symptomatic) hypercalcemia
    6. Malignancies other than TNBC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
    7. Pregnant or lactating women, or intending to become pregnant during the study
    8. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
    9. Significant cardiovascular disease
    10. Presence of an abnormal ECG that is clinically significant in the investigator’s opinion, including complete left bundle branch block, second- or third degree heart block, evidence of prior myocardial infarction, or QT interval corrected using Fridericia’s formula (QTcF) >470 ms demonstrated by at least two consecutive ECGs
    11. Serious infection requiring antibiotics within 2 weeks prior to enrollment, including but not limited to infections requiring hospitalisation or IV antibiotics, such as bacteremia, or severe pneumonia
    12. Major surgical procedure within 4 weeks prior to enrollment or anticipation of the need for a major surgical procedure during the study other than for diagnosis
    13. Treatment with investigational therapy within 30 days prior to initiation of study treatment
    14. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    15. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the atezolizumab formulation
    16. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis,LES,RA, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis (MS), vasculitis, or glomerulonephritis
    17. Prior allogeneic stem cell or solid organ transplantation
    18. History of idiopathic pulmonary fibrosis (IPF, including pneumonitis), drug-induced pneumonitis, organizing pneumonia
    19. Positive test for human immunodeficiency virus (HIV)
    20. Active hepatitis B (positive hepatitis B surface antigen [HBsAg] test or hepatitis B virus [HBV] DNA polymerase chain reaction [PCR] test at screening) or hepatitis C (positive hepatitis C virus antibody test at screening). Note:
    21. Current treatment with anti-viral therapy for HBV
    22. Active tuberculosis
    23. Receipt of a live, attenuated vaccine within 4 weeks prior to enrollment or anticipation that such a live, attenuated vaccine will be required during the study
    24. Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug prior to enrollment
    25. Treatment with systemic immunosuppressive medications
    26. Poor peripheral venous access
    27. Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator’s judgment
    28. Any other serious medical condition or abnormality in clinical laboratory tests
    29. History of hypersensitivity reactions to paclitaxel or other drugs formulated in the same solvent as paclitaxel
    30. History of hypersensitivity reactions to carboplatin
    1. Compressione del midollo spinale non definitivamente trattata con chirurgia e/o radiazione, o compressione del midollo spinale precedentemente diagnosticata e trattata, priva di evidenze che la malattia sia stata clinicamente stabile per almeno 2 settimane precedenti l'arruolamento.
    2. Malattia riconosciuta del sistema nervoso centrale (SNC), ad eccezione delle metastasi del SNC asintomatiche trattate
    3. Versamento pleurico non controllato, versamento pericardico o ascite
    4. Dolore non controllato correlato al tumore
    5. Ipercalcemia non controllata
    6. Neoplasie diverse da TNBC nei 5 anni precedenti l'arruolamento, ad eccezione di quelle con un rischio trascurabile di metastasi o morte e trattate con esito curativo atteso
    7. Donne in gravidanza o in allattamento o che intendono rimanere incinte durante lo studio
    8. Evidenza di malattia concomitante significativa non controllata che potrebbe influenzare l’aderenza al protocollo o l'interpretazione dei risultati, inclusa una significativa malattia epatica (come cirrosi, disturbo convulsivo maggiore non controllato o sindrome della vena cava superiore)
    9. Malattie cardiovascolari significative, come NYHA (Classe II o superiore), infarto miocardico nei 3 mesi precedenti la prima dose, aritmie instabili o angina instabile
    10. Presenza di un elettrocardiogramma anormale (ECG) clinicamente significativo secondo l'opinione dello sperimentatore, incluso il blocco di branca sinistra, blocco cardiaco di secondo o terzo grado, evidenza di precedente infarto del miocardio o intervallo QT corretto usando la formula ‘Fridericia’ (QTcF) >470 ms dimostrato da almeno due ECG consecutivi
    11. Infezione grave che richiede trattamento con antibiotici nelle 2 settimane precedenti l'arruolamento, incluse, ma solo, infezioni che richiedono il ricovero o antibiotici per via endovenosa, come batteriemia o polmonite grave
    12. Procedure chirurgiche maggiori fino a 4 settimane precedenti l'arruolamento o presagio della necessità di una procedura chirurgica maggiore durante lo studio non a scopo diagnostico
    13. Trattamento con terapia sperimentale nei 30 giorni precedenti l'inizio del trattamento in studio
    14. Storia di reazioni allergiche gravi, anafilattiche o altre reazioni di ipersensibilità ad anticorpi chimerici o umanizzati o proteine di fusione
    15. Ipersensibilità o allergia nota ai biofarmaci prodotti in cellule di ovaio di criceto cinese o qualsiasi componente della formulazione di atezolizumab
    16. Storia di malattia autoimmune
    17. Precedenti trapianti di cellule staminali allogeniche o organi solidi
    18. Storia di fibrosi polmonare idiopatica, polmonite indotta da farmaci, polmonite organizzativa o evidenza di polmonite attiva alla TC di screening del torace.
    19. Positività al test del virus dell'immunodeficienza umana (HIV)
    20. Epatite B o C attiva
    21. Pazienti attualmente in trattamento con terapia antivirale per HBV
    22. Tubercolosi attiva
    23. Ricezione di un vaccino vivo attenuato entro 4 settimane precedenti l'arruolamento o presagio che durante lo studio sarà richiesto un vaccino vivo attenuato
    24. Trattamento con agenti immunostimolanti sistemici nelle 4 settimane o cinque emivite del farmaco precedenti l'arruolamento
    25. Trattamento con farmaci immunosoppressori sistemici
    26. Scarso accesso venoso periferico
    27. Abuso illecito di droghe o alcool nei 12 mesi precedenti lo screening, a giudizio dello sperimentatore
    28. Qualsiasi altra grave condizione medica o anomalia nei test di laboratorio clinici che, a giudizio dello sperimentatore, precluda la partecipazione sicura del paziente e il completamento dello studio
    29. Storia di reazioni di ipersensibilità al paclitaxel o ad altri farmaci formulati nello stesso solvente del paclitaxel
    30. Storia di reazioni di ipersensibilità al carboplatino
    E.5 End points
    E.5.1Primary end point(s)
    % Overall survival at 2 years
    % di Sopravvivenza Globale a 2 anni
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years from last patient enrolled
    2 anni dall'arruolamento dell'ultimo paziente
    E.5.2Secondary end point(s)
    Incidence and severity of adverse events and serious adverse events; OS in HR <1% and in HR 1-10%; Post-progression survival; Time to treatment failure; % Overall survival at 2,5 years; Objective response rate
    Incidenza e severità degli eventi avversi (AE) ed eventi avversi seri (SAE); % di Sopravvivenza Globale in HR <1% e in HR 1-10%; Sopravvivenza post-progressione; Tempo al fallimento del trattamento; % di Sopravvivenza Globale a 2 anni e mezzo; Tasso di risposta obiettiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuosly during the study; 2 years from last patient enrolled; during the study every 12 weeks (± 1 week) starting from day 1; during the study every 12 weeks (± 1 week) starting from day 1; 2.5 years from last patient enrolled; during the study every 12 weeks (± 1 week) starting from day 1
    durante lo studio in modo continuativo; 2 anni dall'arruolamento dell'ultimo paziente; durante lo studio ogni 12 settimane (± 1 settimana), a partire dal giorno 1; durante lo studio ogni 12 settimane (± 1 settimana) a partire dal giorno 1; 2,5 anni dall'arruolamento dell'ultimo paziente; durante lo studio ogni 12 settimane (± 1 settimana) a partire dal giorno 1
    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) 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
    Studio in aperto a braccio singolo
    Open, single arm study
    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 concerned16
    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
    Last FU visit after 2 years from LP enrolled
    Ultima visita di Follow-up a due anni dall'ultimo paziente arruolato
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject incapable of giving consent for physical reasons or reason linked to their medical condition
    Soggetto incapace di dare il consenso per motivi fisici o motivi legati alla propria condizione medica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state104
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    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)
    All patients who discontinue study treatment (including due to PD) will be followed for survival approximately every 3 months for 2 years from last patient enrolled or until death, withdrawal of consent, loss to follow-up, or study termination by the Sponsor.
    Imaging tumor evaluation will be performed every 12 weeks.
    Tutti i pazienti che interrompono il trattamento di studio (anche a causa della PD) saranno seguiti per la sopravvivenza ogni 3 mesi circa per 2 anni dall'arruolamento dell’ultimo paziente o fino a decesso, ritiro del consenso, perdita al follow-up o interruzione dello studio da parte dello sponsor. La valutazione del tumore tramite imaging verrà eseguita ogni 12 settimane.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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