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    Summary
    EudraCT Number:2013-005044-29
    Sponsor's Protocol Code Number:GIM12-TYPHER
    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:2014-05-16
    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 number2013-005044-29
    A.3Full title of the trial
    A randomised, multicentre, open-label Phase II trial investigating activity of chemotherapy and lapatinib and Trastuzumab in patients with HER2-positive metastatic breast cancer (MBC) refractory to anti HER2 therapies
    Studio di fase II, randomizzato, multicentrico, in aperto, per valutare l’attività della chemioterapia in associazione a trastuzumab e del lapatinib in associazione a trastuzumab in pazienti con carcinoma mammario metastatico HER2-positivo (MBC), refrattari alle terapie anti-HER2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The objective of the study is to understand if the association of the two drugs (trastuzumab and lapatinib), who both have as target the HER2 receptor with different mechanisms of action, can increase the chance of hitting the tumor compared to the association of trastuzumab to standard chemotherapy treatment, slowing or stopping the growth of cancer cells.
    L’obiettivo dello studio è quello di capire se l’associazione dei due farmaci (trastuzumab e lapatinib), che hanno entrambi come bersaglio il recettore HER2 con differenti meccanismi di azione, possa aumentare la possibilità di colpire il tumore rispetto alla associazione del solo trastuzumab al trattamento stard di chemioterapia, rallentando o bloccando la crescita delle cellule tumorali.
    A.3.2Name or abbreviated title of the trial where available
    TYPHER (TYverb Plus HERceptin in metastatic breast cancer)
    TYPHER (TYverb in assoziazione a HERceptin nel cancro al seno metastatico)
    A.4.1Sponsor's protocol code numberGIM12-TYPHER
    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 supportGlaxoSmithKline
    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 (traversa Migliaro)
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 089301545
    B.5.5Fax number+39 0897724155
    B.5.6E-mailhelpdesk.gim12@oncotech.org
    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 Tyverb 250 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    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 nameTyverb 250 mg film-coated tablets
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Herceptin 150 mg powder for concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameHerceptin 150 mg powder for concentrate for solution for infusion
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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 typehumanized monoclonal antibody IgG1
    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
    HER2-positive metastatic breast cancer (MBC) refractory to anti HER2 therapies
    carcinoma mammario metastatico HER2-positivo (MBC) in pazienti refrattari alle terapie anti-HER2
    E.1.1.1Medical condition in easily understood language
    HER2-positive metastatic breast cancer (MBC) refractory to anti HER2 therapies
    carcinoma mammario metastatico HER2-positivo (MBC) in pazienti refrattari alle terapie anti-HER2
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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
    Define the antitumor activity of the anti-HER2 combinations of lapatinib plus trastuzumab and trastuzumab plus chemotherapy in patients with chemo-refractory advanced disease and HER2 amplified tumours
    Definire l’attività anti-tumorale delle combinazioni anti HER2 di lapatinib in associazione a trastuzumab e del trastuzumab in associazione a chemioterapia in pazienti HER2-positivo (MBC), refrattari alle terapie anti-HER2
    E.2.2Secondary objectives of the trial
    Define the safety profile and quality of life (QoL) of the study treatments
    Define the Progression Free Survival (PFS)
    Definire il profilo di sicurezza e il livello di qualità della vita dei pazienti che ricevono il trattamento sperimentale
    Definire la progressione libera da malattia (PFS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological or cytological confirmed and documented adenocarcinoma of the breast with metastatic disease;
    2. The original tumour specimen must be HER2 IHC 3+ positive or, in case of IHC 2+, a FISH amplification ratio > 2.0. HER2 status determined locally as defined by institutional criteria. IHC and FISH testing will be used to HER2 assessment;
    3. Age ≥18;
    4. Life expectancy of >12 weeks;
    5. ECOG PS 0-1;
    6. Measurable disease as defined by RECIST1.1 criteria;
    7. All patients must have received prior anthracycline-and taxane-based regimens as well as trastuzumab based regimens in either the adjuvant or the metastatic setting. Patients must have been already treated with at least one line of the anti HER2 inhibitor therapy lapatinib for their metastatic breast cancer. A maximum of three previous lines of anti-HER-2 therapies in the metastatic setting are allowed;
    8. Adequate haematological function as defined by: ANC  1.5 x 109/L, platelet count 100 x 109/L, haemoglobin  10 g/dL;
    9. Adequate renal function, as defined by: creatinine 1.5 x UNL;
    10. Adequate hepatobiliary function, as defined by the following baseline liver function tests: total serum bilirubin 1.5 upper normal limit (UNL); alanine amino transferase (ALT), aspartate amino transferase (AST)  2.5xUNL; alkaline phosphatase (AP)  2.5xUNL; if total alkaline phosphatase (AP) > 2.5xUNL, alkaline phosphatase liver fraction must be  2.5xUNL;
    11. Adequate contraception for all fertile patients;
    12. Negative pregnancy test;
    13. Postmenopausal women fulfilling any of the NCCN criteria may be included;
    14. Left ventricular ejection fraction (LVEF) ≥50% during a baseline period of 28 days, as determined by either echocardiography (ECHO) or multi gated acquisition (MUGA) scan. ECHO is the preferred method; the same method of LVEF assessment, ECHO or MUGA, must be used throughout the study and, to the extent possible, be obtained at the same institution. Assessments made within 42 days prior to randomisation are not required to be repeated;
    15. Signed, written informed consent (approved by the institutional review board or independent ethics committee) obtained prior to any study specific procedure initiation or treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements;

    1. Adenocarcinoma mammario metastatico confermato con referto istologico o citologico;
    2. Il campione del tumore originale deve essere HER2 IHC 3+ positivo, nel caso di IHC 2+, un analisi FISH amplificato > 2.0. per determinare lo stato HER2 localmente come definito dai criteri istituzionali. I tests IHC e FISH verranno utilizzati per la valutazione HER2;
    3. Età maggiore/uguale a 18 anni;
    4. Aspettativa di vita > 12 settimane;
    5. ECOG PS 0-1;
    6. Malattia misurabile secondo i criteri RECIST 1.1;
    7. Tutti i pazienti, sia nel setting metastatico che in quello adiuvante, devono essere stati trattati precedentemente con antracicline e taxani cosi come con trastuzumab. Le pazienti con carcinoma mammario metastatico devono essere già state trattate con almeno una prima linea di inibitori anti HER2 (lapatinib). Un massimo di 3 precedenti linee di terapie anti HER2 nel setting metastatico sono permesse;
    8. Adeguato profilo ematologico definito come: conta assoluta dei neutrofili (ANC) ≥1.5 x 109/L Conta piastrinica ≥100 x 109/L, Emoglobina ≥10g/dL;
    9. Adeguata funzionalità renale, definita come: creatinina ≤ 1.5 x UNL;
    10. Adeguato funzionalità epatica, definita al basale come: Bilirubina sierica totale ≤ 1.5 UNL; Alanina aminotrasferasi (ALT) ≤ 2.5 UNL; Aspartato aminotrasferasi (AST) ≤ 2.5 UNL; Fosfatasi alacalina (AP) ≤ 2.5 UNL; se la fosfatasi alcalina totale (AP) è > 2.5xUNL, la frazione di fosfatasi alcalina di origine epatica deve essere ≤ 2.5xUNL;
    11. Adeguata contraccezione per tutte le pazienti in età fertile;
    12. Test di gravidanza negativo;
    13. Le donne con post-menopausa confermata secondo i criteri NCCN possono essere arruolate;
    14. Frazione di eiezione ventricolare sinistra (LVEF) ≥ 50% al basale (28 giorni), confermato da ecocardiografia (ECHO) o da arteriografia a porte multiple (MUGA). L’ECHO è preferibile; lo stesso metodo di valutazione della LVEF, ECHO o MUGA, deve essere utilizzato per tutta la durata dello studio e , per quanto possibile, effettuato presso lo stesso centro. Una valutazione cardiologica effettuata 42 giorni prima della randomizzazione sono considerate valide e non devono essere ripetute;
    15. Consenso informato scritto firmato dal paziente prima di qualsiasi procedura dello studio;
    E.4Principal exclusion criteria
    1. Patients presenting with stage IV MBC at first diagnosis of breast cancer are NOT eligible
    2. History of persistent Grade ≥ 2 hematologic toxicity resulting from previous systemic therapy
    3. Current peripheral neuropathy of NCI-CTCAE, Version 3.0, Grade ≥ 3 at randomization
    4. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
    5. Bone-only disease, unless a measurable lesion is evident as determined by RECIST v1.1 (Eisenhauer et al. 2009):
    6. Bone scan, PET scan or plain films are not considered adequate imaging techniques to measure bone lesions. Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that can be evaluated by cross-sectional imaging techniques such as CT or MRI can be considered as measurable lesions if the soft tissue component meets the definition of measurability described above
    7. Blastic bone lesions are non-measurable.
    8. Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA) / stroke within ≤6 months prior to the first study treatment, myocardial infarction within ≤6 months prior to the first study treatment, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication
    9. Current dyspnoea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy.
    10. Inadequate organ function, evidenced by the following laboratory results within 28 days prior to randomization:
    Inadequate bone marrow function
    - Absolute neutrophil count <1,500 cells/mm3
    - Platelet count <100,000 cells/mm3
    - Haemoglobin <9 g/dL
    Inadequate liver function
    - Total bilirubin > upper limit of normal (ULN) (unless the patient has documented Gilbert’s syndrome)
    - AST (SGOT) or ALT (SGPT) >1.5 times ULN with concurrent serum alkaline phosphatase >2.5 times ULN (unless bone metastases are present).
    Inadequate renal function
    - Serum creatinine>2.0 mg/dL or >177 μmol/L
    - International normalised ratio and activated partial thromboplastin time or partial thromboplastin time >1.5 times ULN (unless on therapeutic coagulation).
    11. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures)
    12. Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
    13. History of receiving any investigational treatment within 28 days of randomization
    14. Current known infection with HIV, HBV, or HCV
    15. Receipt of IV antibiotics for infection within 14 days of randomization
    16. Known hypersensitivity to any of the study drugs
    17. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
    18. Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
    19. Concurrent interventional or non-interventional studies
    1. Le pazienti affette da cancro alla mammella metastatico (MBC) allo stadio IV in prima diagnosi di cancro al seno non sono eleggibili;
    2. Precedente storia di tossicità ematologiche persistenti di grado ≥2 risultanti da precedenti terapie sistemiche;
    3. Neuropatia periferica confermata secondo I criteri NCI-CTCAE, v.3.0, di grado ≥ 3 presente alla randomizzazione;
    4. Precedenti di altre neoplasie maligne negli ultimi 5 anni, ad eccezione di carcinoma in situ della cervice o di carcinoma basocellulare;
    5. Esclusività di metastasi ossee, a meno che una lesione sia evidente e determinata sulla base dei criteri RECIST v 1.1 (Eisenhauer et al. 2009);
    6. La scintigrafia ossea, PET o radiografie non sono considerate tecniche di imaging adeguate per misurare le lesioni ossee. Le lesioni ossee litiche o lesioni miste litiche-blastiche, con componenti identificabili nei tessuti molli, che possono essere valutate con tecniche di imaging in sezione trasversale come la TC o RMN possono essere considerate come lesioni misurabili se il componente di tessuto molle soddisfa la definizione di misurabilità sopra descritto;
    7. Le lesioni ossee blastiche non sono misurabili;
    8. Storia di ipertensione non controllata (sistolica> 150 mmHg e/o diastolica> 100 mm Hg) o di malattie cardiovascolari clinicamente significative clinicamente significativa (attiva): evento cerebrovascolare (CVA)/ictus entro ≤ 6 mesi prima del primo trattamento in studio, infarto del miocardio entro ≤ 6 mesi prima del primo trattamento in studio, angina instabile, insufficienza cardiaca congestizia (CHF) di grado II o superiore secondo i criteri della New York Heart Association (NYHA), o grave aritmia cardiaca che richiede trattamento;
    9. Presenza di dispnea a riposo dovuta a complicanze di neoplasia avanzata, o altre patologiche che richiedono una terapia continua di ossigeno;
    10. Funzionalità degli organi compromessa; confermata dagli esami di laboratorio effettuati nei 28 giorni di screening precedenti la randomizzazione;
    Inadeguata funzionalità del midollo osseo
    - Conta assoluta dei neutrofili < 1,500 cellule/mm3
    - Conta piastrinica <100.000 cellule/mm3
    - Emoglobina <9 g/dL
    Inadeguata funzionalità epatica
    - Bilirubina totale > ULN ( ad eccezione di pazienti con documentata sindrome di Gilbert)
    - AST (SGOT) o ALT (SGPT) > 1.5 ULN con contemporanea ALP > 2.5 ULN (ad eccezione di presenza di metastasi ossee)
    Inadeguata funzionalità renale
    - Creatinina sierica >2.0 mg/dL o > 177 μmol/L
    - Rapporto internazionale normalizzato e tempo di tromboplastina parziale attivato o tempo di tromboplastina parziale > 1.5 UNL ( ad eccezione di una coagulazione terapeutica);
    11. Presenza di patologie gravi sistemiche e non controllate, (ad esempio malattia cardiovascolare, polmonare o metabolica clinicamente significativa; disturbi della cicatrizzazione; ulcere; fratture ossee);
    12. Procedure chirurgiche maggiori o presenza di ferite traumatiche significative nei 28 giorni precedenti l’inizio del trattamento sperimentale o anticipata necessità di un intervento di chirurgia maggiore durante il corso dello studio clinico;
    13. Precedenti trattamenti sperimentali ricevuti nei 28 giorni precedenti la randomizzazione;
    14. Nota positività per HIV, HBV o HCV;
    15. Assunzione di antibiotici di IV classe nei 14 giorni precedenti la randomizzazione;
    16. Nota ipersensibilità ai farmaci in studio;
    17. Conferma da parte del Medico Sperimentatore della incapacità del paziente di seguire o adempiere ai requisiti del protocollo;
    18. Mancanza della integrità fisica del tratto superiore gastrointestinale, sindrome di malassorbimento clinicamente significativa; incapacità di assumere compresse per via orale;
    19. Concomitanza di altri studi interventistici o non interventistici;
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate clinical benefit rate (CBR) for patients treated with lapatinib and trastuzumab and for patients treated with trastuzumab and chemotherapy. CBR is defined as: confirmed complete response (CR) plus partial response (PR) at any time, plus stable disease (SD) for 24 weeks
    Valutare il clinical benefit rate (CBR) per i pazienti trattati con lapatinib e trastuzumab e per i pazienti trattati con trastuzumab in associazione alla chemioterapia. CBR è definito come: Risposta Completa confermata (CR) e Risposta Parziale (PR), ad ogni tempo, e Stabilità di Malattia (SD) per 24 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 36 months
    Approssimativamente 36 mesi
    E.5.2Secondary end point(s)
    -Quality of Life (QoL)
    -Progression Free Survival (PFS)
    -Overall Response Rate (ORR)
    -Overall Survival (OS)
    -Safety and tolerability of both treatments
    - Quality of Life (QoL)
    - Progression Free Survival (PFS)
    - Overall Response Rate (ORR)
    - Overall Survival (OS)
    - Sicurezza e tollerabilità in entrambi i trattamenti
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 36 months
    Approssimativamente 36 mesi
    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 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 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 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) 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 concerned34
    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 No
    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
    Duration of treatment will depend on the response to therapy. Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death
    La durata del trattamento dipende dalla riposta dei pazienti alla terapia. I pazienti riceveranno il trattamento sperimentale fino a progressione, tossicità inaccettabile, ritiro del consenso o decesso
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    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: 154
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 154
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-05-16. Yes
    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 state154
    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)
    During the follow-up patients every 9 weeks will perform a physical examination, vital signs will be measured and evaluated the ECOG PS. A tumor assessment will be performed (the frequency of visits, however, following the local standards). Adverse events will be monitored until resolution and the survival status through telephone contacts if the patient will be followed by other Treatment Centers.
    Nella fase di follow-up i pazienti ogni 9 settimane effettueranno un esame fisico, verranno misurati i segni vitali e valutato l’ECOG PS. Verrà effettuato un tumor assessment (la frequenza delle visite segue comunque gli standard locali). Verranno monitorati gli eventi avversi fino a risoluzione e lo stato di sopravvivenza attraverso contatti telefonici se il paziente verrà seguito presso altri Centri di 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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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