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    Summary
    EudraCT Number:2015-005696-24
    Sponsor's Protocol Code Number:MS200095-0022
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2016-10-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-005696-24
    A.3Full title of the trial
    A Phase II single-arm trial to investigate tepotinib in stage IIIB/IV adenocarcinoma of the lung with MET exon 14 (METex14) skipping alterations after failure of at least one prior active therapy, including a platinum-doublet-containing regimen.
    Essai de phase II à un seul bras, visant à évaluer le tepotinib en traitement des adénocarcinomes bronchiques de stade IIIB/IV avec saut d’exon 14 du gène MET (METex14), après échec d’au moins un traitement actif antérieur dont un doublet à base de sels de platine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tepotinib Phase II study in lung adenocarcinoma harbouring MET exon 14 (METex14) skipping alterations
    A.3.2Name or abbreviated title of the trial where available
    Project blue
    A.4.1Sponsor's protocol code numberMS200095-0022
    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 Center
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    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 nametepotinib
    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 INNtepotinib
    D.3.9.2Current sponsor codeMSC2156119J
    D.3.9.3Other descriptive nameMSC2156119J
    D.3.9.4EV Substance CodeSUB177092
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 nametepotinib
    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 INNtepotinib
    D.3.9.2Current sponsor codeMSC2156119J
    D.3.9.3Other descriptive nameMSC2156119J
    D.3.9.4EV Substance CodeSUB177092
    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
    Stage IIIB/IV adenocarcinoma of the lung with MET exon 14 (METex14) skipping alterations
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    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 efficacy of tepotinib in subjects with advanced adenocarcinoma of the lung harboring
    the MET exon 14 (METex14) skipping alterations, as per objective response (confirmed complete
    response [CR] or partial response [PR]) determined according to Response Evaluation Criteria in
    Solid Tumors (RECIST) version 1.1, based on independent review.
    E.2.2Secondary objectives of the trial
    To further assess the efficacy of tepotinib
    - To assess tolerability and safety of tepotinib
    - To assess PK of tepotinib and its metabolite(s)
    - To assess Health-Related Quality of Life (HRQoL)
    Exploratory Objectives -To explore a possible link between biomarkers of c-Met pathway activation, other relevant oncogenic pathways in plasma, serum and tumor tissue, and the activity of tepotinib
    - To explore the QT/QTc interval concentration relationship based on Cycle 1, Day 1 and Cycle 2, Day 1 data.
    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 study: the DNA extracted for genetic variant analysis may be explored for potential genes involved in the PK, pharmacodynamics, efficacy and safety of tepotinib. Biomarkers of c-Met and other pathway activations, such as but not limited to phospho-c-Met, HGF levels, c-Met genetic mutations, and their potential correlation with prognosis and activity of tepotinib will be assessed. This consists of analyzing the type and the level of biomarkers alteration in serum or tumor tissue and evaluating their association with clinical endpoints. Blood samples for PGx will be evaluated to assess genetic variations of genes. Pharmacogenetics testing might include assessment of genetic polymorphisms responsible for drug metabolism and transport genes and may also be used for assessing polymorphisms linked to Caucasian or Asian descent. Other biomarkers and technologies may be included, the scientific relevance of which emerges at the time of the planned analysis for subjects included in the trial.
    E.3Principal inclusion criteria
    "1. Histologically confirmed advanced adenocarcinoma of the lung, having failed at least one line of systemic therapy, including a platinum-doublet-containing regimen, but having failed a maximum of 2 lines of active therapy;
    2. METex14 skipping alterations, as determined by the central laboratory. Both, archival and
    fresh biopsies are acceptable; In case METex14 skipping alteration has been observed in a subject in a pre-trial setting, it should be ensured that sufficient tissue is available for re-testing before trial entry. Only subjects with METex14 skipping mutation based on trial central testing will be
    enrolled into the trial.
    3. Signed, written informed consent by subject or legal representative prior to any trial-specific screening procedure;
    4. Male or female, ≥ 18 years of age (or having reached the age of majority according to local laws and regulations, if the age of majority is > 18 years of age);
    5. Measurable disease in accordance with RECIST version 1.1;
    6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1."
    E.4Principal exclusion criteria
    1. Subjects with characterized EGFR (documented results; local testing acceptable) that predict sensitivity to EGFR-therapy, including, but not limited to exon 19 deletions and exon 21 alterations;
    2. Subjects with characterized ALK rearrangements (documented results; local testing acceptable);
    3. Active brain metastases (defined as neurologically stable for < 4 weeks and/or symptomatic and/or requiring treatment with steroids and/or leptomeningeal disease). Subjects must have completed any prior treatment for brain metastases ≥ 4 weeks prior to start of therapy (≥ 2 weeks for stereotactic radiosurgery/gamma knife). Subjects who are neurologically stable on symptomatic therapy with anticonvulsants with low drug interaction risk or whose steroids
    are being tapered are eligible. Asymptomatic untreated brain metastases ≤ 1cm are eligible;
    4. Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy;
    5. Need for transfusion within 14 days prior to the first dose of trial treatment;
    6. Prior chemotherapy, biological therapy, radiation therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of trial treatment;
    7. Inadequate hematological, liver, renal, cardiac function; 8. Prior treatment with other agents targeting the HGF/c-Met pathway; 9. Past or current history of neoplasm other than NSCLC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years (for a full list of exlustion criteria please see the study protocol).
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 subjects have completed 4 cycles (84 days) or have prematurely discontinued trial treatment for any reason,
    a futility analysis will be conducted. If 3 or less confirmed responders are observed, the trial will be discontinued.
    The primary analysis of the trial will be conducted once all subjects have either been treated with tepotinib for at least 6 months, died or have prematurely discontinued trial treatment for any reason (following the End of Treatment Visit, if completed), whichever comes first.
    E.5.2Secondary end point(s)
    1. Objective response rate assessed as per Investigator
    2. Duration of response as assessed by independent review committee
    3. Duration of response as assessed by investigator
    4. Objective disease control Rate as assessed by independent review committee
    5. Objective disease control Rate as assessed by investigator
    6. Progression free survival as assessed by independent review committee
    7. Progression free survival as assessed by investigator
    8. Overall survival
    9. Number of subjects with TEAEs and deaths
    10. Number of subjects with markedly abnormal vital signs, ECG, physical examination and ECOG PS.
    11. Health Related Quality of Life Parameters
    12. Maximum plasma concentration (Cmax) of Drug
    13. Volume of distribution (Vz/F) of drug
    14. Total Clearance (Cl) of drug
    E.5.2.1Timepoint(s) of evaluation of this end point
    2, 3, 6, 7: Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months
    8: Baseline until death , assessed up to 20 months
    1, 4, 5, 10, 11: Baseline up to 20 months
    9: From the first dose of study drug administration until 33 days after the last dose of study drug administration, assessed up to 20 months
    12 to 14: pre-dose, at 1.5 hours post-dose and at 4 hours post-dose on Cycle 1, Day 1 and on Cycle 2, Day 1
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Belgium
    France
    Germany
    Italy
    Japan
    Poland
    Spain
    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
    Time point at which all subjects have discontinued and two thirds of the subjects have died.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 35
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    the elderly
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 65
    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)
    normal treatment
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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