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    Summary
    EudraCT Number:2015-000134-30
    Sponsor's Protocol Code Number:I5B-MC-JGDJ
    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:2020-11-04
    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 number2015-000134-30
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of
    Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients
    with Advanced or Metastatic Soft Tissue Sarcoma
    Studio di fase 3, Randomizzato in Doppio Cieco, Controllato verso Placebo di Doxorubicina pi¿ Olaratumab verso Doxorubicina pi¿ Placebo in Pazienti affetti da Sarcoma dei Tessuti Molli di stadio Avanzato o Metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in
    Patients with Soft Tissue Sarcoma
    Uno studio di Doxorubicina pi¿ Olaratumab verso Doxorubicina pi¿ placebo in pazienti affetti da sarcoma dei tessuti molli.
    A.3.2Name or abbreviated title of the trial where available
    ANNOUNCE
    ANNOUNCE
    A.4.1Sponsor's protocol code numberI5B-MC-JGDJ
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02451943
    A.5.4Other Identifiers
    Name:NANumber:I5B-MC-JGDJ
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    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 supportELI LILLY AND COMPANY
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00390554257386
    B.5.5Fax number00390554257348
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1447
    D.3 Description of the IMP
    D.3.1Product nameOlaratumab
    D.3.2Product code LY3012207
    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 INNOlaratumab
    D.3.9.1CAS number 1024603-93-7
    D.3.9.2Current sponsor codeLY3012207
    D.3.9.4EV Substance CodeSUB67904
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 NA
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 INNDOXORUBICIN
    D.3.9.1CAS number 23214-92-8
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06391MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or Metastatic Soft Tissue Sarcoma
    sarcoma dei tessuti molli di stadio avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    cancer of the connective tissue that has worsened or grown in other parts of the body
    carcinoma del tessuto connettivo che ¿ progredito o ha metastatizzato in altri distretti corporei
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10041298
    E.1.2Term Soft tissue sarcomas histology unspecified
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to compare doxorubicin plus olaratumab versus
    doxorubicin plus placebo with respect to OS in 2 populations:
    (1) Patients with advanced or metastatic soft tissue sarcoma (STS) not
    amenable to treatment with surgery or radiotherapy with curative intent
    (2) Patients with advanced or metastatic leiomyosarcoma (LMS) not
    amenable to treatment with surgery or radiotherapy with curative intent
    L¿obiettivo primario ¿ confrontare doxorubicina pi¿ olaratumab vs. doxorubicina pi¿ placebo in termini di OS in 2 popolazioni:
    (1) Pazienti con sarcoma dei tessuti molli in stadio avanzato o metastatico non trattabile mediante chirurgia o radioterapia con intento curativo
    (2) Pazienti con leiomiosarcoma in stadio avanzato o metastatico non trattabile mediante chirurgia o radioterapia con intento curativo
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare doxorubicin plus
    olaratumab versus doxorubicin plus placebo with respect to:
    ¿ Progression-free survival (PFS)
    ¿ Objective response rate (ORR) (complete response [CR] + partial
    response [PR])
    ¿ Disease control rate (DCR; CR + PR + stable disease [SD])
    ¿ Patient-reported outcomes (PROs): Pain, Health-related Quality of
    Life (HRQoL), and health status
    ¿ Duration of response (DoR)
    ¿ Duration of disease control (DDC)
    ¿ Safety and tolerability
    ¿ Pharmacokinetics (PK) and immunogenicity
    Gli obiettivi secondari dello studio riguardano il confronto di doxorubicina pi¿ olaratumab vs. doxorubicina pi¿ placebo in termini di:
    ¿ Sopravvivenza libera da progressione (PFS)
    ¿ Tasso di risposta obiettiva (ORR) (risposta completa [CR] + risposta parziale [PR])
    ¿ Tasso di controllo della malattia (DCR: CR + PR + malattia stabile [SD])
    ¿ Outcome riferiti dal paziente (PRO): dolore, qualit¿ di vita correlata alla salute (HRQoL) e stato di salute
    ¿ Durata della risposta (DoR)
    ¿ Durata del controllo di malattia (DDC)
    ¿ Sicurezza e tollerabilit¿
    ¿ Farmacocinetica (PK) e immunogenicit¿
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18 years or older at study entry
    Histologically confirmed diagnosis of locally advanced unresectable or
    metastatic STS not amenable to curative treatment with surgery or
    radiotherapy. Grade 1 liposarcoma are eligible if there is histological or
    radiographic evidence of evolution to more aggressive disease.
    (excludes GIST & Kaposi). Note: Evidence of disease progression isrequired for patients that are not newly diagnosed.
    Measurable or nonmeasurable but evaluable disease by RECIST 1.1
    ECOG 0-1
    May have had any number of prior systemic therapies for
    advanced/metastatic disease, however may not have received any
    previous treatment with anthracyclines. All previous anticancer
    treatments must be completed = 3 weeks (21 days) prior to first dose of
    study drug.
    Consent to provide archived FFPE tumor tissue or be subject to a pretreatment
    re-biopsy of primary or metastatic tumor tissue future central
    pathology review and translational research (if archived tissue is
    unavailable)
    LVEF ›= 50%
    Life expectancy, in opinion of the investigator, is at least 3 months
    Females of child-bearing potential must have a negative serum
    pregnancy test within 7 days prior to randomization.
    Età pari o superiore a 18 anni al momento dell’ingresso nello studio
    Diagnosi confermata istologicamente di sarcoma dei tessuti molli localmente avanzato non resecabile o metastatico, non trattabile mediante chirurgia o radioterapia curativa. I soggetti con liposarcoma di grado 1 sono considerati eleggibili in presenza di evidenza istologica o radiografica di evoluzione verso una forma più aggressiva. (con l’esclusione di GIST e Kaposi) Nota: L'evidenza di progressione di malattia è richiesta ai pazienti che non hanno ricevuto diagnosi di recente.
    Malattia misurabile o non misurabile ma valutabile sulla base dei criteri RECIST 1.1 ECOG 0-1
    È ammesso qualsiasi numero di terapie sistemiche pregresse per malattia avanzata/metastatica, ma il soggetto non deve essere stato sottoposto a trattamento pregresso con antracicline. Tutte le terapie anticancro pregresse devono essere state completate da = 3 settimane (21 giorni) prima della prima dose di farmaco dello studio.
    Consenso a fornire un campione d’archivio di tessuto tumorale fissato in formalina e incluso in paraffina o a sottoporsi a un nuovo prelievo bioptico di tessuto dal tumore primitivo o metastatico prima del trattamento per una successiva revisione patologica centralizzata e attività di ricerca traslazionale (qualora non sia disponibile un campione tissutale d’archivio)
    LVEF ›=50%
    La speranza di vita, a giudizio dello sperimentatore, è di almeno 3 mesi
    Le donne potenzialmente fertili devono sottoporsi a un test di gravidanza su siero entro 7 giorni prima della randomizzazione e ottenere esito negativo.
    E.4Principal exclusion criteria
    Diagnosed with GIST or Kaposi sarcoma
    Active CNS or brain metastasis at randomization
    The patient has received prior treatment with doxorubicin, epirubicin,
    idarubicin, and/or other anthracyclines or anthracenediones; the patient
    has received treatment with olaratumab or has participated in a prior
    olaratumab trial.
    Prior radiotherapy of the mediastinal/pericardial area or whole pelvis
    radiation
    Electively planned or required major surgery during the study
    Uncontrolled intercurrent illness including, but not limited to, an
    ongoing/active infection requiring parenteral antibiotics, symptomatic
    congestive heart failure (CHF), left ventricular dysfunction (LVEF<50%),
    severe myocardial insufficiency, cardiac arrhythmia, cardiomyopathy, or
    a psychiatric illness/social situation that would limit compliance with
    study requirements
    Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial
    infarction
    QTc interval › 450 msec and › 470 msec for males and females,
    respectively, on screening ECG
    Pregnant or breastfeeding
    Known active fungal, bacterial, or viral infection including human
    immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is
    not required)
    Diagnosi di GIST o sarcoma di Kaposi
    Metastasi del SNC o cerebrali attive alla randomizzazione
    Il paziente ha esperienza di trattamento pregresso con doxorubicina, epirubicina, idarubicina e/o altre antracicline e antracenedioni; il paziente ha esperienza di trattamento pregresso con olaratumab o ha preso parte ad un precedente studio clinico con Olaratumab.
    Radioterapia pregressa dell’area mediastinica/pericardica o irraggiamento dell’intera pelvi
    Intervento chirurgico maggiore necessario o programmato in regime di elezione nel corso dello studio
    Malattia intercorrente non controllata inclusa, tra le altre, un’infezione in corso/attiva con necessità di terapia antibiotica per via parenterale, insufficienza cardiaca congestizia sintomatica, disfunzione del ventricolo sinistro (LVEF <50%), grave insufficienza miocardica, aritmia cardiaca, cardiomiopatia, o malattia psichiatrica/situazione sociale che limiterebbe la compliance ai requisiti previsti dallo studio
    Angina pectoris instabile, angioplastica, stent cardiaco o infarto del miocardio
    Intervallo QTc ›450 ms e ›470 ms rispettivamente per i soggetti di sesso maschile e femminile all’ECG di screening
    Donna incinta o in allattamento
    Infezione micotica nota, batterica o virale nota, incluse le infezioni da virus dell’immunodeficienza umana (HIV) o da virus dell’epatite (A, B o C) (screening non richiesto)
    E.5 End points
    E.5.1Primary end point(s)
    Overall suvival
    Sopravvivenza globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    time from randomization to death
    Tempo intercorrente tra la randomizzazione e il decesso
    E.5.2Secondary end point(s)
    ¿ PFS
    ¿ ORR
    ¿ DCR
    ¿ Time to first worsening of the mBPI-sf (Brief Pain Inventory Short
    Form Modified) "worst pain" score
    ¿ Duration of response
    ¿ Duration of disease control
    ¿ Safety and tolerability
    ¿ Pharmacokinetics (PK) and immunogenicity
    ¿ PFS
    ¿ ORR
    ¿ DCR
    ¿ Tempo al primo peggioramento del punteggio mBPI-sf (Brief Pain Inventory Short Form Modified) di ¿dolore peggiore¿
    ¿ Durata della risposta
    ¿ Durata del controllo di malattia
    ¿ Sicurezza e tollerabilit¿
    ¿ Farmacocinetica (PK) e immunogenicit¿
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS is determined from the date of randomization and the date on which
    disease progresses or the date on which the patient dies, from any
    cause, whichever is earlier.
    Response rates (ORR=CR+PR/Randomized subjects)
    (DCR=CR+PR+SD/Randomized subjects) will be based on evaluations
    done every 6 weeks until radiographic documentation of progression.
    PRO: Day 1 of every cycle, Short-Term Follow-Up and Long-Term Follow-
    Up
    DoR and duration of disease control is measured from the time
    measurement criteria are first met for CR or PR until the first date of
    objective progression is observed .
    Safety and tolerability: On study treatment, Short-Term Follow-Up and
    Long-Term Follow-Up
    PK and immunogenicity: At various time points according to the protocol
    and in the event of IRR
    La PFS ¿ intesa come l¿intervallo di tempo intercorrente tra la data di randomizzazione e la data in cui la malattia progredisce o il paziente muore per qualsiasi causa (a seconda di quale evento si verifichi per primo).
    I tassi di risposta (ORR=CR+PR/soggetti randomizzati) (DCR=CR+PR+SD/soggetti randomizzati) si baseranno su valutazioni condotte ogni 6 settimane fino a documentazione radiografica di progressione della malattia.
    PRO: giorno 1 di ogni ciclo, follow-up a breve termine e follow-up a lungo termine
    La DoR e la durata del controllo di malattia sono intese come l¿intervallo di tempo intercorrente tra il primo momento in cui i criteri di misurazione per CR o PR vengono soddisfatti e la prima osservazione di progressione obiettiva della malattia.
    Sicurezza e tollerabilit¿: durante
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    Switzerland
    Taiwan
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 460
    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)
    Following PD, patients will be contacted every 2 months to obtain
    survival information and subsequent anticancer treatment (if
    applicable) for the first 2 years, then every 6 months until the patient's
    death or overall study completion.
    Dopo il peggioramento del tumore, i pazienti saranno contattati ogni 2 mesi per raccogliere informazioni sullo stato di salute e per sapere se si si stanno sottoponendo a un nuovo trattamento antitumorale ( se applicabile) per i primi 2 anni. Successivamente i pazienti saranno contattati all¿incirca ogni 6 mesi fino al decesso del paziente o alla conclusione dello studio
    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 Decision2015-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
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