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    Summary
    EudraCT Number:2011-006330-16
    Sponsor's Protocol Code Number:IRFMN-MPM-6077
    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:2013-02-26
    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 number2011-006330-16
    A.3Full title of the trial
    ATREUS TRIAL
    A PHASE II STUDY ON THE ACTIVITY OF TRABECTEDIN IN PRETREATED EPITHELIOID OR BIPHASIC/SARCOMATOID MALIGNANT PLEURAL MESOTHELIOMA (MPM)
    STUDIO DI FASE II SULL'ATTIVITA' DELLA TRABECTEDINA IN PAZIENTI CON MESOTELIOMA PLEURICO MALIGNO DI TIPO
    EPITELIOIDE PRETRATTATO O CON TIPO SARCOMATOIDE/MISTO Studio ATREUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the activity of the drug trabectedin in patients with a lung cancer called mesothelioma
    Studio di ricerca per la valutazione dell'attivita' del farmaco
    trabectedina in pazienti con tumore del polmone mesotelioma
    A.3.2Name or abbreviated title of the trial where available
    ATREUS Study
    Studio ATREUS
    A.4.1Sponsor's protocol code numberIRFMN-MPM-6077
    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 SponsorIstituto di ricerche farmacologiche "Mario Negri"
    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 supportPharma Mar S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di ricerche farmacologiche "Mario Negri"
    B.5.2Functional name of contact pointLital Hollander
    B.5.3 Address:
    B.5.3.1Street AddressVia La Masa, 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number390239014640
    B.5.5Fax number390233200231
    B.5.6E-maillital.hollander@marionegri.it
    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 Yondelis
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    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 Powder for 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 INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 typeAntineoplastic agent
    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
    Malignant Pleural Mesothelioma
    Mesotelioma pleurico maligno
    E.1.1.1Medical condition in easily understood language
    Cancer of the lung lining (pleura) named mesothelioma
    Tumore della membrana dei polmoni (pleura) del tipo mesotelioma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the activity of trabectedin in patients with epithelial MPM relapsing after treatment with pemetrexed plus platinum-based drugs
    Valutare l’attività di trabectedina in pazienti con MPM di tipo epitelioide in ricaduta dopo trattamento con pemetrexed e derivati del platino.
    E.2.2Secondary objectives of the trial
    To assess the activity of trabectedin in patients with biphasic or sarcomatoid either as first line treatment or following a previous course of platinum derivates and pemetrexed.
    To assess the tolerability and safety of trabectedin treatment.
    To explore the activity of trabectedin with respect to some biological features of MPM
    Valutare l’attività di trabectedina in pazienti con MPM di tipo sarcomatose o bifasico, sia come trattamento di prima linea, o in seguito a precedente terapia a base di pemetrexed e platino derivati.
    Valutare la tollerabilità e la sicurezza d’impiego di trabectedina
    Studiare gli effetti di trabectedina su alcuni marker biologici del mesotelioma pleurico maligno.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Full title: ATREUS trial. A phase II study on the activity of Trabecteding in pretreated epithelioid or biphasic/sarcomatoid malignant pleural mesothelioma (MPM) - Biological sub-study
    Version: 2 (21/12/2012)
    Objectives:
    To explore the potential value of miRs determination in mesothelioma patients, particularly in relation to the treatment with trabectedin.
    To evaluate miRs profiles in plasma of all mesothelioma patients participating the phase II study, collecting samples before trabectedin treatment

    Titolo: Studio ATREUS. Studio di fase II sull'attività della trabectedina in pazienti con mesotelioma pleurico maligno di tipo tepitelioide pretrattato o con tipo sarcomatoide/misto - sottostudio biologico
    Versione: 2 (del 21/12/2012)
    Obiettivi:
    Esplorare il valore potenziale della deteminazione dei profili miR in pazienti affetti da mesotelioma, in particolare in relazione al trattamento con trabectedina.
    Valutare i profili miR nel plasma di tutti i pazienti partecipanti allo studio di fase II, attraverso la raccolta di campioni plasmatici prima del trattamento con trabectedina.
    E.3Principal inclusion criteria
    Cytological or histological diagnosis of unresectable MPM;
    age >18 years;
    Performance status 0-2 (ECOG);
    measurable disease (CT-PET);
    normal bone marrow reserve;
    adequate liver and renal function;
    not more than one previous chemotherapy course (of pemetrexed plus platinum derivative); previous chemotherapy course concluded at least 3 weeks prior to recruitment;
    atients must have recovered from toxicities of prior treatment (grade ≤ 1), life expectancy >3 months;
    written informed consent;
    negative pregnancy test.
    Patients who have received palliative radiation are eligible if <30% of bone marrow was irradiated and normal hematological function was completely regained.
    Diagnosi citologica o istologica di mesotelioma pleurico maligno inoperabile; età >18 anni;
    Performance status 0-2 (ECOG);
    malattia misurabile mediante TAC o PET;
    riserva midollare conservata;
    funzioni epatiche e renali adeguate;
    non più di un trattamento precedente (a base di pemetrexed e derivati del platino); distanza di almeno tre settimane dall’ultimo ciclo di terapia concluso;
    pieno recupero da eventuali tossicità del precedente trattamento (grado ≤1); spettanza di vita >3 mesi;
    consenso informato scritto;
    se applicabile, test gravidanza negativo.
    I pazienti che hanno ricevuto radioterapia palliativa sono eleggibili se è stata irradiata una porzione del midollo <30% e le condizioni ematologiche sono nella norma.
    E.4Principal exclusion criteria
    Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy);
    adjuvant chemotherapy;
    severe concomitant illness;
    uncompensated diabetes mellitus or other condition absolutely contra-indicating dexamethasone (20 mg, used as pre-medication);
    enrollment in other trials;
    pregnant or breast-feeding women;
    prior exposure to trabectedin;
    history of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse;
    active viral hepatitis or chronic liver disease;
    unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias;
    Active major infection; other serious concomitant illnesses; Brain / leptomeningeal involvement.
    Radioterapia con intento curativo della parete toracica (in concomitanza o in precedenza alla chemioterapia); chemioterapia adiuvante;
    patologie concomitanti gravi;
    diabete mellito scompensato o qualsiasi altra controindicazione all’impiego di desametasone (usato alla dose di 20 mg come pre-medicazione);
    partecipazione in altri studi di ricerca; gravidanza o allattamento;
    precedente assunzione di trabectedina;
    presenza di altre patologie neoplastiche (ad eccezione di basalioma o carcinoma della cervice uterina in situ, adeguatamente trattati), a meno che non siano in remissione da almeno cinque anni e giudicate di trascurabile potenziale di recidiva;
    epatite virale attiva o epatopatia cronica;
    cardiopatia instabile compresi: scompenso cardiaco, angina pectoris, infarto miocardico nell’anno precedente all’arruolamento, ipertensione incontrollata o aritmie;
    infezioni maggiori attive;
    altre patologie concomitanti gravi;
    interessamento cerebrale a/o meningeo.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    Progression free survival (PFS),
    objective response rate
    overall survival (OS).
    Safety will be evaluated based on reported AEs, clinical laboratory assessments, vital signs and physical examinations. Adverse events will be encoded using the Medical Dictionary for Regulatory Activities (MedDRA) and graded using NCI-CTCAE ver 4. .
    Sopravvivenza libera da progressione (PFS),
    tasso di risposta oggettiva,
    sopravvivenza (OS).
    La sicurezza della trabectedina sarà valutata a partire dai report di eventi avversi, esame obiettivo e di laboratorio. Gli eventi avversi saranno codificati usando il Medical Dictionary for Regulatory Activities (MedDRA) e classificati usando il sistema NCI-CTCAE versione 4.
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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
    Ultima visita ultimo soggetto arruolato (LVLS)
    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 months
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state79
    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)
    None
    Nessuno
    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 Decision2013-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-09
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