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    Summary
    EudraCT Number:2017-001016-11
    Sponsor's Protocol Code Number:SAKK17/16
    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:2021-01-13
    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 number2017-001016-11
    A.3Full title of the trial
    Lurbinectedin Monotherapy in Patients with Progressive Malignant Pleural Mesothelioma. A Multicenter, Single-arm Phase II Trial
    Lurbinectedin Monotherapy in Patients with Progressive Malignant Pleural Mesothelioma. A Multicenter, Single-arm Phase II Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with Lurbinectedin monotherapy in patients with mesothelioma
    Studio con lurbinectedina in monoterapia in pazienti con mesotelioma
    A.3.2Name or abbreviated title of the trial where available
    SAKK 17/16
    SAKK 17/16
    A.4.1Sponsor's protocol code numberSAKK17/16
    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 SponsorSAKK
    B.1.3.4CountrySwitzerland
    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 SA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSAKK
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 33
    B.5.3.2Town/ cityBerna
    B.5.3.3Post codeCH - 3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 31 508 41 51
    B.5.5Fax number+41 31 389 92 00
    B.5.6E-mailMartina.Schneider@sakk.ch
    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 nameLurbinectedina
    D.3.2Product code PM01183
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNLurbinectedin
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pleural Mesothelioma
    Mesotelioma pleurico
    E.1.1.1Medical condition in easily understood language
    Pleural Tumor
    Tumore della pleura
    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 PT
    E.1.2Classification code 10059518
    E.1.2Term Pleural mesothelioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess efficacy and safety of lurbinectedin monotherapy in patients with progressive malignant mesothelioma
    Valutare l¿efficacia e la sicurezza di una monoterapia con lurbinectedina in pazienti con mesotelioma maligno in progressione.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: 1.0
    Date: 29/05/2017
    Title: Translational Research
    Objectives: The objective of this subproject is to identify the different variants and in particular deleterious
    variants of genes related to the mechanism of action of lurbinectedin

    Farmacogenetica
    Versione: 1.0
    Data: 29/05/2017
    Titolo: Ricerca Traslazionale
    Obiettivi: L'obiettivo di questo sottoprogetto ¿ quello di individuare le diverse varianti e in particolare di quelle varianti deleterie di geni legati al meccanismo d'azione di lurbinectedina
    E.3Principal inclusion criteria
    - Histologically confirmed malignant mesothelioma (all histologies);
    - Progression on or after one line of platinum-based combination chemotherapy;
    - = 1 line of treatment with an immune checkpoint inhibitor;
    - Prior systemic treatment stopped at least 4 weeks before registration;
    - Measurable or evaluable disease according to the modified RECIST criteria for malignant pleural mesothelioma;
    - ECOG PS = 1;
    - Adequate bone marrow function, hepatic function and renal function.
    - Mesotelioma maligno confermato istologicamente (tutte le istologie);
    - Progressione durante o dopo una linea di trattamento chemioterapico basato sulla combinazione con platino;
    - = 1 linea di trattamento con un inibitore del checkpoint immunitario;
    - Precedente trattamento sistemico interrotto almeno 4 settimane prima dell’inclusione;
    - Malattia misurabile o valutabile in base ai criteri RECIST modificati per il mesotelioma pleurico maligno;
    - ECOG PS = 1;
    - Funzioni del midollo osseo, epatica e renale adeguate.
    E.4Principal exclusion criteria
    - Known brain or leptomeningeal metastases;
    - More than one previous line of chemotherapy;
    - Concomitant use of other anti-cancer drugs, anti-cancer surgery or radiotherapy except for local pain control and/or dyspnea (e.g. pleurodesis);
    - Severe or uncontrolled endocrinopathy due to previous immune checkpoint inhibitor treatment (if applicable);
    - Known history of human immunodeficiency virus or active chronic hepatitis C or B virus infection or any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.
    - Metastasi nota del cervello o leptomeningee;
    - Più di una precedente linea di chemioterapia;
    - Uso concomitante di altri farmaci antitumorali, di interventi chirurgici per il cancro o di radioterapia ad eccezione di quella utilizzata per il controllo del dolore locale e/o della dispnea (ad es. Pleurodesi);
    - Endocrinopatia grave o non controllata causata da un precedente trattamento con un inibitore del checkpoint immunitario (se applicabile);
    - Presenza in anamnesi di infezioni da virus da immunodeficienza umana o di infezioni croniche attive da virus dell'epatite C o B o di qualsiasi infezione sistemica attiva non controllata.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) at 12 weeks
    L’intervallo di tempo libero da progressione (PFS) alla 12a settimana
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    Progression-free survival (PSF); Objective response (OR); Disease Control rate (DCR); Overall Survival (OS); Time to treatment failure (TTF); Adverse events
    Sopravvivenza libera da progressione (PFS); Risposta obiettiva (OR); Percentuale di controllo della malattia (DCR) ; Sopravvivenza globale (OS); Intervallo di tempo al fallimento del trattamento (TTF); Eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    From registration to one of the following events, whichever occurs first:
    ¿ Relapse or progression
    ¿ Death due to any cause; During Trial treatment; 12 weeks; Until death for any cause; Until treatment discontinuation due to any reason; From registration until 30 days after last administration of lurbinectedin or until the start of a new antitumor therapy, whichever occurs first.
    Dall'arruolamento fino a uno dei seguenti eventi, a seconda di quello che si verifica per primo:
    - ricaduta o progressione
    - decesso per qualsiasi causa; Durante il trattamento in studio; 12 settimane; Fino al decesso per qualsiasi causa; Fino a interruzione del trattamento per qualsiasi causa; Dall'arruolamento fino a 30 giorni dopo l'ultima somministrazione di lurbinectedina o fino all'inizio di una nuova terapia antiotumorale, a seconda di ci¿ che 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Italy
    Switzerland
    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 months6
    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 months6
    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: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 43
    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)
    Patients will be treated according to the local clinical practice
    I pazienti saranno trattati in accordo alla pratica clinica locale
    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 Decision2018-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
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