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    Summary
    EudraCT Number:2013-003695-13
    Sponsor's Protocol Code Number:GEXMab52201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-11-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003695-13
    A.3Full title of the trial
    Randomized, controlled, open label, multicenter, phase II study to evaluate the efficacy and safety of CetuGEX™ plus chemotherapy in comparison to cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Studio di fase II in aperto, multicentrico, randomizzato e controllato volto alla valutazione dell'efficacia e della sicurezza di CetuGEX™ più chemioterapia rispetto a cetuximab più chemioterapia nel trattamento dei pazienti affetti da carcinoma a cellule squamose della testa e del collo di stadio III/IV ricorrente e/o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    non-blinded phase II study to compare the efficacy and safety of CetuGEX™ plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Studio per valutare l’efficacia e la sicurezza di CetuGEX™ più chemioterapia rispetto a cetuximab più chemioterapia nel trattamento dei pazienti affetti da carcinoma a cellule squamose della testa e del collo
    A.3.2Name or abbreviated title of the trial where available
    RESGEX study
    Studio RESGEX
    A.4.1Sponsor's protocol code numberGEXMab52201
    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 SponsorGlycotope GmbH
    B.1.3.4CountryGermany
    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 supportGlycotope GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlycotope GmbH
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Roessle-Str. 10
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13125
    B.5.3.4CountryGermany
    B.5.4Telephone number+493094892653
    B.5.5Fax number+493094892609
    B.5.6E-mailkathrin.stechmann@glycotope.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCetuGEX
    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 INNCetuGEX
    D.3.9.3Other descriptive nameCETUGEX
    D.3.9.4EV Substance CodeSUB31982
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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) Yes
    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 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 5 mg/mL solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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) Yes
    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
    stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Carcinoma a cellule squamose della testa e del collo (SCCHN) di stadio III/IV ricorrente e/o metastatico
    E.1.1.1Medical condition in easily understood language
    stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck
    Carcinoma a cellule squamose della testa e del collo di stadio III/IV ricorrente e/o metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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
    The primary objective of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of PFS.
    L'obiettivo primario dello studio è valutare l'efficacia di CetuGEX™ per il trattamento di pazienti con SCCHN di stadio III/IV ricorrente e/o metastatico rispetto a cetuximab (entrambi in combinazione con chemioterapia a base di platino) in termini di sopravvivenza libera da progressione (PFS).
    E.2.2Secondary objectives of the trial
    Secondary objectives are as follows:
    1. To evaluate further efficacy criteria, safety and QoL of patients with stage III/IV recurrent and/or metastatic SCCHN treated with CetuGEX™ as compared to cetuximab (both in combination with platinum-based chemotherapy).
    2. To assess PK parameters and profiles of CetuGEX™.
    3. To assess efficacy and safety based on genetic markers for immune response (FcγR allotypes) and biomarkers.
    Gli obiettivi secondari sono:
    1. Valutare ulteriori criteri di efficacia, sicurezza e qualità della vita (QoL) in pazienti con SCCHN di stadio III/IV ricorrente e/o metastatico trattati con CetuGEX™ rispetto a cetuximab (entrambi in combinazione con chemioterapia a base di platino).
    2. Valutare i parametri farmacocinetici (PK) e i profili di CetuGEX™.
    3. Valutare l'efficacia e la sicurezza sulla base dei marcatori genetici di risposta immunitaria (allotipi recettori per Fc-gamma [FcR]) e biomarcatori.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically confirmed recurrent and/or metastatic EGFR positive SCCHN not eligible for local treatment.
    2. Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
    3. Patients aged at least 18 years at screening.
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    5. Minimum life expectancy of 3 months.
    6. Tissue samples available for specific disease and therapy related biological assessments.
    7. If female and of childbearing potential, is non-lactating and has negative pregnancy test results at screening and prior to randomization.
    8. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or using highly effective contraceptives with a failure rate < 1% according to the Note for Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95) of the European Medicines Agency (EMA). Male patients who have partners of childbearing potential have to confirm adequate use of highly effective contraceptives as well.
    9. Willing and able to comply with the protocol.
    10. Willing and able to provide written informed consent.
    1. Pazienti con SCCHN EGFR-positivo ricorrente e/o metastatico confermato istologicamente non idonei al trattamento locale.
    2. Pazienti con malattia misurabile secondo i Criteri di valutazione della risposta dei tumori solidi (RECIST) 1.1.
    3. Pazienti di età pari o superiore a 18 anni allo screening.
    4. Stato di perfomance ECOG (Eastern Cooperative Oncology Group) pari a 0 o 1.
    5. Speranza di vita minima pari a 3 mesi.
    6. Campioni di tessuto disponibili per valutazioni biologiche relative alla terapia e specifiche della malattia.
    7. Per le pazienti di sesso femminile e in età fertile: non essere in allattamento e presentare risultati negativi al test di gravidanza allo screening e prima della randomizzazione.
    8. Per le pazienti di sesso femminile: non essere in età fertile (ovvero, in post-menopausa da almeno 1 anno o chirurgicamente sterile [legamento bilaterale delle tube, ovariectomia bilaterale o isterectomia]) o utilizzare contraccettivi altamente efficaci con un tasso di fallimento <1% secondo le Linee guida per gli studi di sicurezza non clinica in relazione allo svolgimento degli studi clinici sull'uomo e l'autorizzazione all'immissione in commercio di prodotti farmaceutici (CPMP/ICH/286/95) dell'Agenzia europea per i medicinali (EMA).
    I pazienti di sesso maschile con partner in età fertile devono confermare l'adeguato impiego di contraccettivi altamente efficaci.
    9. Disponibile e in grado di rispettare il protocollo.
    10. Disponibile e in grado di fornire un consenso informato scritto.
    E.4Principal exclusion criteria
    1. Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening.
    2. Cetuximab or other EGFR targeting agent treatment, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening.
    3. Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization.
    4. Concomitant anti-tumor therapy or concomitant immunotherapy.

    5. Concomitant corticosteroid treatment unless specified within the protocol.
    6. Clinical evidence of brain metastasis or leptomeningeal involvement.
    7. Patients with nasopharyngeal tumors.
    8. Concomitant malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g., basal cell cancer of the skin, cervical cancer or breast cancer in situ). Patients with previous malignancies but without evidence of disease for at least 5 years will be allowed to enter the study.
    9. Patients with renal or hepatic impairment (serum creatinine and bilirubin > 1.5 fold above the upper limit of normal ranges) and transaminase > 5 fold above the upper limit of normal ranges) and patients with hematology parameters outside the normal ranges (hemoglobin < 9 g/dl, absolute neutrophil count < 1500/mm3 and platelet count < 105/mm3) at screening.
    10. Clinically active infections ≥ Grade 2 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 and/or requiring intravenous antibiotics.
    11. Known active hepatitis B or C.
    12. Known human immunodeficiency virus (HIV) infection.
    13. Myocardial infarction within 6 months prior to screening.
    14. Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening.
    15. History of keratitis requiring medical interventions within the last 5 years.
    16. Patients with any other disorder that, in the opinion of the investigator, might interfere with the conduct of the study.
    17. Patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
    18. Patients institutionalized by official means or court order.
    19. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous CetuGEX™ administration.
    20. Prior allergic reaction to a monoclonal antibody, grade 3 IRR or any grade 4 reaction to a monoclonal antibody.
    21. Known sensitivity to any component of the investigational medicinal product (IMP) and medication used in this study.
    1. Previa chemioterapia sistemica, tranne se somministrata come parte di un trattamento multimodale per malattia localmente avanzata completato più di 6 mesi prima dello screening.
    2. Cetuximab o altro trattamento a base di farmaco mirato all'EGFR, tranne se somministrato come parte di un trattamento multimodale per malattia localmente avanzata completato più di 6 mesi prima dello screening.
    3. Intervento chirurgico (ad eccezione di interventi minori come biopsia diagnostica o impianto di catetere endovenoso [port]) o irradiazione entro 30 giorni prima della randomizzazione.
    4. Terapia antitumorale o immunoterapia concomitante.
    5. Trattamento concomitante con corticosteroidi salvo se specificato nel protocollo.
    6. Evidenza clinica di metastasi cerebrale o coinvolgimento leptomeningeo.
    7. Pazienti con tumori rinofaringei.
    8. Malignità concomitante, ad eccezione di tumori trattati adeguatamente con elevata probabilità di guarigione (ad es. carcinoma cutaneo basocellulare, tumore cervicale o carcinoma mammario in situ). I pazienti con altre neoplasie precedenti ma senza evidenza di malattia per un periodo di almeno 5 anni potranno essere ammessi allo studio.
    9. Pazienti con insufficienza epatica o renale (creatinina sierica e bilirubina >1,5 volte al di sopra del limite superiore dei valori normali e transaminasi >5 volte al di sopra del limite superiore dei valori normali) e pazienti con parametri ematologici al di fuori dei range normali (emoglobina <9 g/dl, conta assoluta dei neutrofili < 1500/mm3 e conta piastrinica < 105/mm3) allo screening.
    10. Infezioni clinicamente attive ≥ grado 2 in base alla Terminologia Comune stabilita dall’Istituto Nazionale dei Tumori - Criteri per gli eventi avversi (NCI-CTCAE) versione 4 e/o che richiedono antibiotici per via endovenosa.
    11. Nota epatite B o C attiva.
    12. Nota infezione da virus dell'immunodeficienza umana (HIV).
    13. Infarto del miocardio nei 6 mesi precedenti lo screening.
    14. Insufficienza cardiaca congestizia sintomatica (New York Heart Association [NYHA] Grado 3 o 4), angina pectoris instabile entro 6 mesi prima dello screening, aritmia cardiaca significativa, storia di ictus o attacco ischemico transitorio entro 1 anno prima dello screening.
    15. Storia di cheratite che ha richiesto interventi medici negli ultimi 5 anni.
    16. Pazienti con qualsiasi altro disturbo che, a giudizio dello sperimentatore, potrebbe interferire con lo svolgimento dello studio.
    17. Pazienti in una condizione instabile (per es. disturbo psichiatrico, storia recente di abuso di farmaci o di alcool, condizione in grado di interferire con l'aderenza allo studio, entro 6 mesi prima dello screening) o altrimenti paziente ritenuto inaffidabile o incapace di soddisfare i requisiti del protocollo.
    18. Pazienti istituzionalizzati con mezzi ufficiali o per ordine del tribunale.
    19. Assunzione di qualsiasi altro prodotto medicinale sperimentale negli ultimi 30 giorni prima della randomizzazione o eventuale somministrazione precedente di CetuGEX™.
    20. Precedente reazione allergica ad un anticorpo monoclonale, reazione correlata all'infusione (IRR) di grado 3 o qualsiasi reazione di grado 4 a un anticorpo monoclonale.
    21. Sensibilità nota a qualsiasi componente del prodotto medicinale sperimentale (IMP) o dei farmaci utilizzati in questo studio.
    E.5 End points
    E.5.1Primary end point(s)
    progression-free survival
    Sopravvivenza libera da progressione
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, every 6 weeks after day of randomization until Week 18 and every 8 weeks thereafter
    Screening, ogni 6 settimane dopo la randomizzazione fino alla settimana 18, ogni 8 settimane successivamente
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include:
     PFS as assessed by independent centralized reading according to modified irRC.
     Objective response rate (ORR, i.e., CR + PR) according to modified irRC at the end of combination treatment.
     Best overall response rates (CR, PR, SD) according to modified irRC including maintenance therapy treatment.
     Clinical benefit rate (CBR, i.e., CR + PR + SD) according to modified irRC.
     Overall survival (OS) defined as time from randomization until death of any cause.
     Time to treatment failure (TTF), as defined in Section 10.3.1.2.
     QoL scores assessed using EORTC-QLQ-C30 and EORTC-QLQ-H&N35H.
    In addition, PFS and all secondary efficacy endpoints listed above will be analyzed by FcγRIIIa-allotype subgroups (i.e., FF, FV and VV), p16 status, and other potential parameters.
    • PFS valutata mediante lettura centralizzata indipendente;
    • Tasso di risposta obiettiva (ORR; ovvero risposta completa [CR] + risposta parziale [PR]) alla fine della terapia di combinazione;
    • Migliori tassi di risposta globale (inclusa la terapia di mantenimento);
    • Tasso di beneficio clinico (CBR, ovvero CR + PR + malattia stabile [SD]);
    • Durata della risposta;
    • Sopravvivenza globale (OS);
    • Tempo al fallimento del trattamento (TTF);
    • Punteggi QoL, valutati in base ai questionari sulla qualità della vita (QLQ) dell'Organizzazione Europea per la Ricerca e il Trattamento del Cancro (EORTC), EORTC QLQ C30 e EORTC QLQ H&N35.
    Inoltre, verranno analizzati la PFS e tutti gli endpoint secondari di efficacia sopra elencati per i sottogruppi degli allotipi FcRIIIa (ossia FF, FV, VV), stato di p16 e altri potenziali parametri.
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuously, see protocol
    Continuamente, vedere il protocollo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Poland
    Romania
    Spain
    United States
    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
    24 months after randomization of the last patient for assessment of overall survival
    24 mesi dopo la randomizzazione dell'ultimo paziente per la valutazione della sopravvivenza globale
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 240
    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 patients will be treated until disease progression or intolerable toxicities.
    I pazienti saranno trattati fino alla progressione della malattia o insorgenza di tossicità intollerata.
    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 Decision2014-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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