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    Summary
    EudraCT Number:2013-002053-30
    Sponsor's Protocol Code Number:EMR200095-005
    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:2014-02-07
    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 number2013-002053-30
    A.3Full title of the trial
    A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK of
    MSC2156119J as Monotherapy in Subjects with MET+ Advanced Hepatocellular Carcinoma with
    Child Pugh Class A Liver Function Who Have Failed Sorafenib Treatment
    Studio multicentrico, a braccio singolo, di Fase Ib/II per valutare l’efficacia, la sicurezza e la farmacocinetica (PK) di MSC2156119J in monoterapia in soggetti affetti da carcinoma epatocellulare avanzato MET positivo (MET+) con funzionalità epatica Child Pugh di classe A, non responsivi al trattamento con Sorafenib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK of
    MSC2156119J as Monotherapy in Subjects with MET+ Advanced Hepatocellular Carcinoma with
    Child Pugh Class A Liver Function Who Have Failed Sorafenib Treatment
    Studio multicentrico, a braccio singolo, di Fase Ib/II per valutare l’efficacia, la sicurezza e la farmacocinetica (PK) di MSC2156119J in monoterapia in soggetti affetti da carcinoma epatocellulare avanzato MET positivo (MET+) con funzionalità epatica Child Pugh di classe A, non responsivi al trattamento con Sorafenib
    A.3.2Name or abbreviated title of the trial where available
    c-Met Second-line HCC
    A.4.1Sponsor's protocol code numberEMR200095-005
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurterstrasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number496151725200
    B.5.6E-mailservice@merckgroup.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecMET Kinase Inhibitor
    D.3.2Product code MSC2156119J
    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 INNMSC2156119J
    D.3.9.1CAS number 1100598-30-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 namecMET Kinase Inhibitor
    D.3.2Product code MSC2156119J
    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 INNMSC2156119J
    D.3.9.1CAS number 1100598-30-8
    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.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
    Hepatocellular Carcinoma
    Carcinoma Epatocellulare
    E.1.1.1Medical condition in easily understood language
    Liver Cancer
    Cancro al fegato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10073071
    E.1.2Term Hepatocellular carcinoma
    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
    •Phase Ib: Determine the RP2D of MSC2156119J administered orally once daily over a 21-day cycle in subjects with advanced HCC pretreated with sorafenib and
    Child Pugh class A liver function. The target RP2D is 500 mg.
    •Phase II: Evaluate efficacy of MSC2156119J in subjects with MET+ advanced HCC
    pretreated with sorafenib and Child Pugh class A liver function.

    •Fase Ib: Determinare la dose raccomandata per la fase II (RP2D) di MSC2156119J somministrato oralmente una volta al giorno nell’arco di un ciclo di 21 giorni a soggetti affetti da carcinoma epatocellulare avanzato (hepatocellular carcinoma, HCC), pretrattati con sorafenib, e con funzionalità epatica Child Pugh di classe A. L’obiettivo di RP2D è 500 mg.
    •Fase II: Valutare l’efficacia di MSC2156119J in soggetti affetti da HCC MET+, pretrattati con sorafenib, e con funzionalità epatica Child Pugh di classe A.
    E.2.2Secondary objectives of the trial
    • Phase Ib: Characterize the single and multiple dose PK of MSC2156119J.
    Assess antitumor activity and biochemical response of MSC2156119J.
    Evaluate safety and tolerability of MSC2156119J.
    • Phase II: Evaluate the safety and tolerability of MSC2156119J.
    Evaluate antitumor activity and biochemical response of MSC2156119J.
    • Fase Ib: Caratterizzare la farmacocinetica (PK) di MSC2156119J in dosaggio singolo e multiplo.
    Misurare l’attività antitumorale e la risposta biochimica di MSC2156119J.
    Valutare la sicurezza e la tollerabilità di MSC2156119J.
    • Fase II: Valutare la sicurezza e la tollerabilità di MSC2156119J.
    Misurare l’attività antitumorale e la risposta biochimica di MSC2156119J.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed HCC;
    2. Child Pugh Class A liver function score;
    3. For phase II only: MET+ status
    4. Male or female, 18 years of age or older;
    5. Measurable disease in accordance with RECIST Version 1.1;
    6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
    (inclusive);
    7. Previously treated with sorafenib for ≥ 4 weeks and discontinued sorafenib treatment
    at least 14 days prior to Day 1 due to either intolerance or radiographic progression;
    8. Signed and dated informed consent indicating that the subject (or legally acceptable
    representative if applicable by local laws) has been informed of all the pertinent
    aspects of the trial prior to enrollment;
    9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
    tests and other trial procedures; and
    10. Life expectancy of at least 3 months as judged by the investigator.
    1.HCC confermato istologicamente o citologicamente;
    2.Punteggio di classe A sulla scala della funzionalità epatica Child Pugh;
    3.Solo per la fase 2: Stato di MET+.
    4.Paziente di sesso maschile o femminile, di età uguale o superiore ai 18 anni;
    5.Malattia misurabile in base ai criteri RECIST Versione 1.1;
    6.PS secondo ECOG 0-1 (incluso);
    7.Pazienti trattati in precedenza con sorafenib per ≥ 4 settimane e che hanno interrotto il trattamento con sorafenib almeno 14 giorni prima del Giorno 1 a causa di intolleranza o progressione radiografica;
    8.Consenso informato firmato e datato che indichi che il soggetto (oppure un rappresentante legalmente accettabile, se applicabile in base alle leggi locali) è stato informato di tutti gli aspetti della sperimentazione prima dell’arruolamento;
    9.volontà e possibilità del soggetto di rispettare le visite programmate, i piani di trattamento, gli esami di laboratorio e tutte le altre procedure della sperimentazione; e
    10.Aspettativa di vita di almeno 3 mesi a giudizio dello Sperimentatore.
    E.4Principal exclusion criteria
    1. Prior systemic anticancer treatment for advanced HCC (except for sorafenib as
    described in the inclusion criteria);
    2. Prior treatment with any agent targeting the HGF/c-Met pathway;
    3. Local-regional therapy within 4 weeks before Day 1
    4. Impaired cardiac function
    1. Precedente trattamento antitumorale sistemico per HCC avanzato (escluso
    sorafenib come descritto nei criteri di inclusione);
    2. Precedente trattamento con qualsiasi agente avente come target la pathway HGF/c-Met;
    3. Terapia loco-regionale durante le 4 settimane precedenti il Giorno 1
    4. Funzione cardiaca alterata
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib: Number of DLTs occuring in Cycle 1

    Phase II: Progression-free survival (PFS) status at 12 weeks
    Fase Ib: incidenza delle tossicità limitanti la dose (dose limitingtoxicities, DLT) nel Ciclo 1
    Fase II:Stato della sopravvivenza libera da progressione (Progression-Free Survival, PFS) a 12 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    - Time to Progression according to RECIST v. 1.1
    -Progression free survival according to RECIST v. 1.1 and mRECIST for HCC
    -Time-to-symptomatic progression according to RECIST v. 1.1
    -Overall survival
    -Best overall response rate
    -Disease control rate
    -Biological response rate
    - Tempo di progressione secondo RECIST v. 1.1
    - Sopravvivenza libera da progressione secondo RECIST v. 1.1 e mRECIST per
    HCC
    - Tempo alla progressione sintomatica secondo RECIST v. 1.1
    - sopravvivenza globale
    - Migliore tasso di risposta globale
    - Tasso di controllo della malattia
    - Tasso di risposta biologica
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    To determine the recommended phase II dose (RP2D) of MSC2156119J
    Determinare la dose raccomandata per la fase II (RP2D) di MSC2156119J
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    The end of the trial will be defined as 12 months after the last subject’s first dose of MSC2156119J.
    La fine della sperimentazione sarà definita come 12 mesi dopo la prima dose di MSC2156119J dell’ultimo soggetto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    Subjects who are on active treatment with MSC2156119J at the time of end of the trial will be offered further treatment with MSC2156119J and assessments will be made as appropriate to determine whether a potential benefit from further treatment is seen.
    Ai soggetti che sono in trattamento attivo con MSC2156119J al momento della fine della sperimentazione sarà offerto un ulteriore trattamento con MSC2156119J e verranno effettuate delle valutazioni in maniera opportuna per determinare un eventuale potenziale beneficio derivante dal trattamento.
    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 Decision2014-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-14
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