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    Summary
    EudraCT Number:2010-023794-19
    Sponsor's Protocol Code Number:VICTORII
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-29
    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 number2010-023794-19
    A.3Full title of the trial
    II Phase Study for the evaluation of Full-oral, metronomic schedule of Vinorelbine (VNB) and Capecitabine (CAPE) in locally advanced or metastatic breast cancer (BC) patients (pts)
    Studio di Fase II di valutazione della schedula metronomica orale Vinorelbina+Capecitabina nelle pazienti con carcinoma mammario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    II Phase Study for the evaluation of Full-oral, metronomic schedule of Vinorelbine (VNB) and Capecitabine (CAPE)
    Studio di Fase II di valutazione della schedula metronomica orale Vinorelbina+Capecitabina
    A.3.2Name or abbreviated title of the trial where available
    Victor 2
    Victor 2
    A.4.1Sponsor's protocol code numberVICTORII
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA OSPEDALIERA S. GERARDO DI MONZA
    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 supportA.O. San Gerardo di Monza
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.O. San Gerardo di Monza
    B.5.2Functional name of contact pointResponsabile scientifico
    B.5.3 Address:
    B.5.3.1Street AddressVia Pergolesi, 33
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number039.2339286
    B.5.6E-mailstudio.victor2@gmail.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 XELODA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    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.3.4Pharmaceutical form 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 INNcapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 NAVELBINE
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE PHARMA Srl
    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.3.4Pharmaceutical form Capsule, soft
    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 INNVinorelbine
    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 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.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
    Breast cancer
    Tumore mammario
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    Tumore mammario
    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 LLT
    E.1.2Classification code 10065348
    E.1.2Term Breast adenocarcinoma metastatic
    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
    Activity evaluation of the full-oral metronomic schedule in terms of Clinical Benefit (CB=CR/PR/SD ≥24 weeks)
    Valutare l’attivita' della schedula metronomica full-oral in termini di Clinical Benefit (CB=CR/PR/SD ≥24 settimane)
    E.2.2Secondary objectives of the trial
     PFS rate for 1 year  Toxicity  TTP  Answer duration
     PFS rate a 1 anno  Tossicita'  TTP  Durata della risposta
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    LIFE QUALITY:
    Vers:
    Date:
    Title:Compliance to treatment
    Objectives:Evaluate, using validated questionnaires, the compliance of the patients enrolled in the proposed experimental therapy

    QUALITA DELLA VITA:
    Vers:
    Data:
    Titolo:Compliance al trattamento
    Obiettivi:Valutare, tramite questionario validato, la compliance dei pazienti arruolati alla terapia sperimentale proposta

    E.3Principal inclusion criteria
     Presence of locally advanced or metastatic cancer not eligible for surgery or radiotherapy.  Patients must have been previously treated with anthracyclines and taxanes for adiuvant or neoadiuvant and/or metastatic, or patients cannot be considered eligible to treatments with these drugs due to co-pathologies or clinical conditions.  HER2 positive patients cannot be eligible to an anti Her2 treatment because of a severe reduction of ejection fraction or must not be eligible due to no other therapeutic options. AntiHER2 treatment has to be interrupted at least 4 weeks prior to enrolment.  Patients can have been treated with hormontherapy in adiuvant and/or metastatic setting. Treatment has to be suspended at least 2 weeks bifore enrolment.  Life expectancy > 24 weeks
     Presenza di malattia localmente avanzata o metastatica non candidabile ad intervento chirurgico o radioterapia.  Le pazienti devono aver ricevuto precedenti trattamenti con antracicline e taxani per il setting adiuvante o neoadiuvante e/o metastatico oppure le pazienti devono essere considerate non candidabili al trattamento con tali farmaci in relazione a co-patologie o condizioni cliniche.  Le pazienti HER2 positive non devono essere candidabili a trattamento anti Her2 per severa riduzione della frazione d’eiezione o non devono essere piu' candidabili per esaurimento delle opzioni terapeutiche. Il trattamento antiHER2 deve essere sospeso almeno 4 settimane prima dell’arruolamento.  Le pazienti possono essere state trattate con ormonoterapia nel setting adiuvante e/o metastatico. Il trattamento deve essere interrotto almeno 2 settimane prima dell’arruolamento.  Aspettativa di vita &gt; 24 settimane.
    E.4Principal exclusion criteria
     Absence of histology and biological characteristics of breast cancer.  Presence of brain metastases and meningeal carcinomatosis.  Radiotherapy required on bone lesions, in absence of other target lesions  Previous treatment with capecitabine e/o vinorelbine.  Serious historical hypersensitiveness to vinca alkaloids and/or to fluoropirimidines.  Co-morbidity that contraindicates the use of fluorine pirimidine and/or vinca alkaloids.
     Assenza d’istologia o di caratterizzazione biologica della neoplasia mammaria  Presenza di metastasi cerebrali e carcinosi meningea  Necessita' di radioterapia su lesioni ossee, in assenza d’altre lesioni target  Precedente trattamento con capecitabina e/o vinorelbina.  Storia di severa ipersensibilita' agli alcaloidi della vinca e/o alle fluoropirimidine.  Comorbidita' che controindichino l’utilizzo di fluoro pirimidine e/o alcaloidi della vinca.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the clinical benefit (CB ≥ 24 weeks) defined as the proportion of patients whose best response is comprehensive or complete response, partial response or stable disease maintained for a period greater than or equal to 24 weeks according to RECIST
    L’end point primario dello studio è il beneficio clinico (CB ≥24 settimane) definito come la proporzione di pazienti la cui miglior risposta globale sia o la risposta completa, risposta parziale o la stabilità di malattia mantenuta per un periodo superiore o uguale a 24 settimane in accordo ai criteri RECIST (VERS. 1.1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    ≥ 24 weeks
    ≥ 24 settimane
    E.5.2Secondary end point(s)
    1. The rate of progression-free survival at one year is defined as the proportion of patients from the date of enrollment to the next year had no tumor progression or death from any cause. For patients with measurable disease at baseline, the progression is determined by reference to the RECIST criteria (version 1.1). In the absence of measurable disease only for patients with metastatic bone progression will be defined as follows: a. Occurrence of one or more new bone lytic lesions b. Occurrence of one or more new lesions outside the bone c. Unequivocal progression of existing bone metastases. The occurrence of complications related to the presence of bone metastases will not be considered as evidence of disease progression if there are at least one of the three previous criteria. 2. Time to progression defined as the time between the date of enlistment and the date of documented progression of disease or death from any cause. 3. Duration of response, defined as the time between the date of first documented response (complete or partial response) and the date on which occurs the first progression or death from any cause. 4. The toxicity resulting from treatment will be determined by reference to the Common Terminology Criteria criteria (CTCAE) version 3.0. Will be reported on the incidence of adverse events, serious adverse events and changes from baseline in vital signs and laboratory values. 5. Quality of life. Will be given a specific questionnaire for assessing quality of life. 6. Adherence to treatment. There will be a diary that provides information about vinorelbine and capecitabine therapy, you take them and the problems related to them.
    1. Il tasso di sopravvivenza libera da progressione ad un anno definito come la proporzione di pazienti che dalla data d’arruolamento al successivo anno non hanno avuto progressione tumorale o morte per qualsiasi causa.
    Per le pazienti con malattia misurabile al basale, la progressione è valutata in relazione ai criteri RECIST (versione 1.1).
    In assenza di malattia misurabile per le pazienti con solo localizzazioni metastatiche ossee la progressione sarà definita come segue:
    a. Comparsa di una o più nuove lesioni litiche ossee
    b. Comparsa di una o più nuove lesioni al di fuori dell’osso
    c. Progressione inequivocabile delle preesistenti metastasi ossee
    La comparsa di complicanze legate alla presenza di metastasi ossee non sarà considerata come evidenza di progressione di malattia se non vi sono almeno uno dei tre criteri precedenti.
    2. Tempo alla progressione definito come il tempo intercorrente tra la data di arruolamento e la data di progressione documentata di malattia o la morte per qualsiasi causa.
    3. Durata della risposta, definita come il tempo intercorrente tra la data della prima documentata risposta (risposta parziale o completa) e la data in cui si verifica la prima progressione o la morte per qualsiasi causa.
    4. La tossicità derivante dal trattamento che verrà valutata in relazione ai criteri Common Terminology Criteria (CTCAE) versione 3.0. Verranno riportati l’incidenza degli eventi avversi, gli eventi avversi seri e alterazioni rispetto al basale nei segni vitali e nei valori di laboratorio.
    5. Qualità di vita. Sarà dato un questionario specifico per la valutazione della qualità di vita.
    6. Aderenza al trattamento. Verrà dato un diario che fornisce informazioni riguardanti la terapia con vinorelbina e capecitabina, la loro assunzione e le problematiche a loro connesse.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 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 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 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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned11
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 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 state120
    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 patient will be followed every 3 months, as per normal medical practice
    La paziente verrà seguita ogni 3 mesi come da normale prassi
    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 Decision2011-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
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