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    Summary
    EudraCT Number:2012-002447-14
    Sponsor's Protocol Code Number:TV1011-LC-303
    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:2012-12-21
    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 number2012-002447-14
    A.3Full title of the trial
    A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-
    1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A
    Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV)
    Non-Small Cell Lung Cancer
    Studio di fase III multinazionale, randomizzato, in aperto con custirsen (TV-1011/OGX-011) in combinazione con docetaxel rispetto al solo docetaxel come trattamento di seconda linea in pazienti con cancro polmonare avanzato o metastatico (stadio IV) non a piccole cellule
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out if being treated with docetaxel and custirsen (new
    experimental drug) can increase survival in patients with advanced or
    metastatic non-small cell lung cancer, compared to the treatment with
    docetaxel alone. The patients must have received one prior line of
    platinum-based systemic anticancer therapy
    Studio per definire se il trattamento con docetaxel in combinazione con custirsen (nuovo farmaco sperimentale) può aumentare la sopravvivenza in pazienti con cancro polmonare avanzato o metastatico non a piccole cellule, rispetto al trattamento con il solo docetaxel. I pazienti devono aver ricevuto una precedente linea di terapia anticancro sistemica a base di platino.
    A.3.2Name or abbreviated title of the trial where available
    ENSPIRIT
    ENSPIRIT
    A.4.1Sponsor's protocol code numberTV1011-LC-303
    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 SponsorTEVA PHARMACEUTICALS INDUSTRIES LTD
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries, Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldecker Str. 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number-
    B.5.5Fax number-
    B.5.6E-mailInfo.era-clinical@teva.de
    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 nameCustirsen
    D.3.2Product code OGX-011, TV-011
    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 INNcustirsen
    D.3.9.1CAS number 685922-56-9
    D.3.9.2Current sponsor codeOGX-011, TV-011
    D.3.9.3Other descriptive nameCustirsen 20mg/ml concentrato per soluzione per infusione
    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 Yes
    D.3.11.13.1Other medicinal product typeoligonucleotide antisenso
    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
    Non-Small Cell Lung Cancer stage IV
    Carcinoma polmonare di stadio IV non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Metastatic Non-Small Cell Lung Cancer
    Carcinoma polmonare metastatico non a piccole cellule
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if the combination regimen of custirsen and docetaxel
    improves the Overall Survival (OS) of patients with advanced or
    metastatic (Stage IV) NSCLC who have received one prior line of
    platinum-based systemic anticancer therapy.
    Valutare se il regime di combinazione di custirsen e docetaxel migliora la sopravvivenza globale (OS) dei pazienti con NSCLC avanzato o metastatico (stadio IV) che hanno ricevuto una precedente linea di terapia anticancro sistemica a base di platino.
    E.2.2Secondary objectives of the trial
    Efficacy:
    1.To compare Progression Free Survival (PFS) between patients
    receiving docetaxel with or without custirsen.
    2.To compare Objective Response Rate (ORR) between patients
    receiving docetaxel with or without custirsen.
    3.To compare Duration of Objective Response between patients
    receiving docetaxel with or without custirsen
    4.To compare Disease Control Rate (DCR) between patients receiving
    docetaxel with or without custirsen
    5.To compare Duration of Disease Control (DC), between patients
    receiving docetaxel with or without custirsen.
    Safety:
    To assess the safety profile of custirsen in combination with docetaxel.
    Efficacia:
    1. Confrontare la sopravvivenza libera da progressione (PFS) tra i pazienti che ricevono docetaxel con o senza custirsen.
    2. Confrontare il tasso di risposta oggettiva (ORR) tra i pazienti che ricevono docetaxel con o senza custirsen.
    3. Confrontare la durata di risposta oggettiva (risposta completa [CR] o risposta parziale [PR]) tra i pazienti che ricevono docetaxel con o senza custirsen.
    4. Confrontare il tasso di controllo della malattia (DCR) tra i pazienti che ricevono docetaxel con o senza custirsen.
    5. Confrontare la durata del controllo della malattia (DC) (ad es. CR, PR o malattia stabile [SD]), tra i pazienti che ricevono docetaxel con o senza custirsen.
    Sicurezza:
     Valutare il profilo di sicurezza di custirsen in combinazione con docetaxel.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC:
    Vers:2.0
    Date:2012/08/22
    Title:A Multinational, Randomized, Open-Label Phase III Study of Custirsen (TV-1011/OGX-011) In Combination With Docetaxel Versus Docetaxel As A Second-Line Treatment In Patients With Advanced or Metastatic (Stage IV) Non-Small Cell Lung Cancer
    Objectives:DNA samples will be collected for possible use in future analyses for the assessment of possible associations between genetic polymorphisms in genes related but not limited to cell proliferation and apoptosis pathways and response to custirsen.

    FARMACOGENOMICA:
    Vers:2.0
    Data:2012/08/22
    Titolo:Studio di fase III multinazionale, randomizzato, in aperto con custirsen (TV-1011/OGX-011) in combinazione con docetaxel rispetto al solo docetaxel come trattamento di seconda linea in pazienti con cancro polmonare avanzato o metastatico (stadio IV) non a piccole cellule.
    Obiettivi:I campioni di sangue verranno raccolti per un possibile uso in analisi future per la determinazione di possibili associazioni tra il polimorfismo genetico nei geni correlati ma non solo alla proliferazione cellulare e alla via di apoptosi e alla risposta a custirsen.

    E.3Principal inclusion criteria
    1.Patients must have a histologically or cytologically confirmed,
    unresectable, advanced or metastatic (Stage IV per American Joint
    Committee on Cancer 7th edition of tumor, nodes and metastases
    classification of malignant tumors [TNM] staging) NSCLC
    2.Males or females ≥ 18 years of age at screening.
    3.Life expectancy of > 12 weeks from screening, according to the Investigator's assessment.
    4.Patients must have received one prior line of platinum-based systemic
    anticancer therapy for advanced or metastatic NSCLC. Prior maintenance
    therapy is allowed and will be considered as the same line of therapy
    when continued at the end of a treatment regimen.
    5.Patients must have documented radiological disease progression
    either during or after the first-line therapy.
    6.Patients must have at least one measurable lesion per RECIST 1.1
    criteria.
    7.ECOG PS of 0 or 1 at screening.
    8.Have adequate bone marrow, renal and liver functions at screening as
    defined below:
    -Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    -Platelet count ≥ 100 x 109/L
    -Hemoglobin ≥ 9 g/dL
    -Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    -Total Bilirubin≤1.0 x ULN (unless elevated secondary to benign
    conditions such as Gilbert's disease)
    -Aspartate transaminase (AST) and alanine transaminase (ALT)≤1.5 x
    ULN
    9.Resolution of any toxic effects of prior therapy to Grade ≤1 according
    to the National Cancer Institute Common Terminology Criteria for
    Adverse Events (NCI CTCAE), version 4.0 (exception of alopecia and ≤
    Grade 2 peripheral neuropathy).
    10.Females of child-bearing potential must have negative serum
    pregnancy test within 72 hours before randomization.
    11.Women of child-bearing potential will practice a highly effective
    method of birth control during and for 3 months after the
    chemotherapy/custirsen last dose. Male partners of women of childbearing
    potential can be either surgically sterile, or will ensure that their
    female partner utilizes a highly effective contraceptive method during
    and for 3 months after chemotherapy/custirsen last dose.
    12.Patients must be willing and able to give written informed consent
    prior to any protocol-specific procedures being performed and comply
    with the protocol requirements for the duration of the study
    1. I pazienti devono avere un NSCLC confermato istologicamente o citologicamente, non resecabile, avanzato o metastatico (stadio IV secondo la 7^ edizione della classificazione di tumori, noduli e metastasi dei tumori maligni [TNM] dell'American Joint Committee on Cancer [AJCC]). 2. Uomini e donne di età ≥ 18 anni allo screening.
    3. Aspettativa di vita &gt; 12 settimane dallo screening, secondo la valutazione dello Sperimentatore.
    4. I pazienti devono aver ricevuto una precedente linea di terapia anticancro sistemica a base di platino per NSCLC avanzato o metastatico. Una precedente terapia di mantenimento è ammessa e sarà considerata come la stessa linea di terapia se proseguita alla fine del regime di trattamento.
    5 I pazienti devono presentare una progressione della patologia confermata radiologicamente durante o dopo la terapia di prima linea.
    6. I pazienti devono presentare almeno una lesione misurabile per mezzo dei criteri RECIST 1.1.
    7. Stato di prestazione ECOG pari a 0 o 1 allo screening.
    8. Funzioni di midollo osseo, reni e fegato adeguate allo screening, come definito di seguito:
     conta assoluta dei neutrofili (ANC) ≥ 1,5 x 109/l
     conta piastrinica ≥ 100 x 109/l
     emoglobina ≥ 9 g/dl
     creatinina sierica ≤ 1,5 volte il limite superiore della norma (ULN)
     bilirubina totale  1,0 volte il limite superiore della norma (a meno che elevato secondariamente a una condizione benigna , come la sindrome di Gilbert)
     aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT)  1,5 volte il limite superiore della norma
    9. Risoluzione di eventuali effetti tossici di precedente terapia di grado ≤1 in base ai Criteri terminologici comuni per gli eventi avversi dell'Istituto nazionale tumori (NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events) versione 4.0 (fatta eccezione per alopecia e neuropatia periferica di grado ≤ 2).
    10. Le donne potenzialmente fertili devono inoltre presentare un test di gravidanza sul siero con risultato negativo nelle 72 ore precedenti la randomizzazione.
    11. Le donne in età fertile utilizzeranno un metodo contraccettivo altamente efficace durante e per 3 mesi dopo l'ultima dose di chemioterapia/custirsen. I partner uomini di donne potenzialmente fertili devono essere chirurgicamente sterili oppure garantire che la loro partner di sesso femminile utilizza un metodo contraccettivo altamente efficace durante e per 3 mesi dopo l'ultima dose di chemioterapia/custirsen.
    12. I pazienti devono acconsentire a ed essere in grado di fornire un consenso informato scritto prima dell'esecuzione di qualsiasi procedura specifica del protocollo e conformarsi ai requisiti del protocollo per la durata dello studio.
    E.4Principal exclusion criteria
    1.Patients treated with any systemic anti-cancer therapy for NSCLC
    within 21 days prior to randomization (6 weeks for bevacizumab).
    2.Radiotherapy ≤ 2 weeks prior to randomization. Patients must have
    recovered from all radiotherapy-related toxicities.
    3.Major surgical procedure within 4 weeks prior to randomization.
    Patient must have recovered from all surgery-related complications.
    4.Patients with known central nervous system (CNS) metastases
    (Patients with any clinical signs of CNS metastases must have a CT or
    MRI of the brain to rule out CNS metastases in order to be eligible for
    participation in the study. Patients who have had brain metastases
    treated with radiotherapy or surgically removed with no residual disease
    confirmed by imaging should be clinically stable and off corticosteroid
    treatment at least 3 weeks prior to randomization).
    5.Patients with current diagnosis or a history of another active primary
    malignancy (except in situ carcinoma of the cervix, adequately treated
    non-melanomatous skin cancers, clinically localized prostate cancer,
    superficial bladder cancer or other malignancy treated at least 5 years
    previously with no evidence of recurrence).
    6.Severe or unstable medical conditions such as heart failure, ischemic
    heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus,
    psychiatric condition, as well as an ongoing cardiac arrhythmia requiring medication (≥ Grade 2, according to NCI CTCAE v4.0) or any
    other significant or unstable concurrent medical illness that in the
    opinion of the Investigator would preclude protocol therapy.
    7.A history of events such as myocardial infarction, cerebrovascular
    accident (CVA) or acute hepatitis within 3 months of randomization or
    treatment of a major active infection within one month of randomization,
    or any other significant event that in the opinion of the Investigator
    would preclude protocol therapy.
    8.Planned concomitant participation in another clinical trial of an
    experimental agent, vaccine, or device. Concomitant participation in
    observational studies is acceptable.
    9.Female patients who are breastfeeding.
    10.Patients previously treated with docetaxel for NSCLC or with known
    severe hypersensitivity to taxane therapies.
    1. Pazienti trattati con una qualsiasi terapia anticancro sistemica per NSCLC nei 21 giorni precedenti la randomizzazione (6 settimane per bevacizumab). 2. Radioterapia ≤ 2 settimane prima della randomizzazione. I pazienti devono essersi ripresi da tutte le tossicità legate alla radioterapia.
    3. Importante intervento chirurgico entro 4 settimane dalla randomizzazione. Il paziente deve essersi ripreso da tutte le complicazioni legate all'intervento chirurgico.
    4. Pazienti con metastasi note al sistema nervoso centrale (CNS) (i pazienti con segni clinici di metastasi CNS devono sottoporsi a TAC o risonanza magnetica del cervello per escludere metastasi CNS per poter essere idonei alla partecipazione allo studio. I pazienti le cui metastasi cerebrali sono state trattate con radioterapia oppure rimosse chirurgicamente senza malattia residua confermata tramite imaging devono essere stabili e non sotto trattamento con corticosteroidi almeno 3 settimane prima della randomizzazione).
    5. Pazienti con diagnosi corrente o storia di un'altra malignità primaria attiva (tranne carcinoma in situ della cervice uterina, tumori cutanei non melanomatosi trattati in modo adeguato, cancro alla prostata clinicamente localizzato, cancro alla vescica superficiale o altra malignità trattata almeno 5 anni prima con nessuna evidenza di recidiva).
    6. Condizioni mediche gravi o instabili, come scompenso cardiaco, ischemia, ipertensione incontrollata, diabete mellito incontrollato, condizione psichiatrica, nonché aritmia cardiaca in corso che richiede l'uso di farmaci (≥ grado 2, secondo NCI CTCAE v4.0) o altra patologia clinica significativa o instabile che secondo l'opinione dello Sperimentatore precluderebbe la terapia del protocollo.
    7. Una storia di eventi come infarto miocardico, incidente cerebrovascolare (CVA) o epatite acuta entro 3 mesi dalla randomizzazione o trattamento di importante infezione attiva entro un mese dalla randomizzazione o qualsiasi altro evento significativo che secondo lo Sperimentatore precluderebbe la terapia del protocollo.
    8. Prevista partecipazione concomitante a un'altra sperimentazione clinica di un agente, un vaccino o un dispositivo sperimentale. La partecipazione concomitante a studi di osservazione è accettabile.
    9. Pazienti di sesso femminile che stanno allattando al seno.
    10. Pazienti precedentemente trattati con docetaxel per NSCLC o con grave ipersensibilità nota alle terapie con taxano.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint and variable for the study is OS, defined as the
    time from date of randomization to the date of death from any cause.
    L'endpoint primario e la variabile per questo studio è la OS, definita come il tempo dalla data di randomizzazione alla data di decesso per qualsiasi causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    date of death
    data della morte
    E.5.2Secondary end point(s)
    -Progression Free Survival (PFS)
    -Objective Response Rate (ORR)
    -Duration of Objective Response
    -Disease Control Rate (DCR)
    -Duration of Disease Control
    -Progressione libera da malattia (PFS)
    -Grado di risposta oggettiva (ORR)
    -Durata della risposta oggettiva
    -Grado di controllo della malattia(DCR)
    -Durata del controllo della malattia
    E.5.2.1Timepoint(s) of evaluation of this end point
    -PFS, defined as the time from the date of randomization to the first
    objective documented progression per RECISTv1.1 or death due to any
    cause,whichever occurs first.
    -OR is defined as achieving a best overall response of CR or PR,as
    defined using RECISTv1.1.
    -Duration of OR is defined as time from first occurrence of CR or PR
    (whichever is first recorded) until date of the first documented disease
    progression or death, whichever occurs first.
    -DC is defined as achieving a best overall response of CR, PR or SD.
    -Duration of DC is defined as the time from randomization to the date of
    the first documented disease progression or death, whichever occurs
    first.
    -PFS, def. come il tempo tra la rand. e la prima progressione oggettiva della malattia documentata (ppomd) tramite RECIST v1.1 o il decesso per una qualsiasi causa, a seconda dell’evento che si verifica per primo. -La risposta oggettiva (OR) viene definita come il raggiungimento della migliore risposta generale di CR o PR, in base alla definizione RECIST v1.1. -La durata della risposta oggettiva viene def. come l'intervallo fra il primo evento di CR o PR (a seconda di cosa viene registrato per primo) e la data della ppomd o il decesso, a seconda di cosa si verifica per primo. -DC def. come il raggiungimento della migliore risposta generale di CR o PR o SD. -La durata di DC viene def. come l'intervallo fra la rand. e la ppomd o il decesso, a seconda di cosa si verifica per primo
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To compare the arms with respect to QoL parameters, FACT-L and EQ-5D
    Paragonare i bracci di trattamento relativamente ai parametri QoL, FACT-L e EQ-5D
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.2.3.1Comparator description
    Docetaxel 75mg/m2 IV on D1 of every 21-day cycle
    Docetaxel 75mg/m2 EV il G1 di ogni cliclo di 21gg
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA109
    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
    Australia
    China
    Georgia
    Israel
    Korea, Republic of
    New Zealand
    Philippines
    Russian Federation
    Singapore
    Taiwan
    Thailand
    United States
    Vietnam
    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
    2 formal interim analyses are planned for stopping the trial early based on inadequate evidence of clin. benefit or futility: see stop criteria pg11-protocol.If study continues final efficacy analysis is planned after 850 death events.All pts who discont.study treatm. will be followed to collect further anticancer treatment and survival information until death,loss to fup,withdrawal of consent,or up to 12 months after EoT visit for last patient on the study,whichever comes first.
    Tutti i paz. che disc. il tratt. in studio saranno seguiti per registrare i tratt. antitumorali e la sopravvivenza, fino alla morte, perdita al Fup, ritiro del CI o fino a 12 mesi dopo la visita di fine del tratt. per l'ultimo paz. in studio.
    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 months53
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months58
    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.1.1Number 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: 440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 660
    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 state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 463
    F.4.2.2In the whole clinical trial 1100
    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 discontinued study treatment will be followed to
    collect further anticancer treatment and survival information until
    death, loss to follow-up, withdrawal of consent, or up to 12 months after the end of treatment visit for the last patient on the study, whichever comes first. Patients who are removed from study treatment for any reason other than disease progression or death will be followed for documented radiological disease progression.
    I pazienti che discontinuano il trattamento in studio verranno seguiti per registrare i successivi trattamenti antitumorali e la sopravvivenza, fino alla morte, perdita al fup, ritiro del consenso, o fino a 12 mesi dopo la visita di fine trattamento per l'ultimo paziente in studio, a seconda di ciò che si verifica prima. I pazienti che non vengono più trattati per qualsiasi motivo, che non sia la DP o la morte, verranno seguiti per la DP documentata radiologicamente.
    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 Decision2013-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
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