Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-001538-33
    Sponsor's Protocol Code Number:MS200095-0031
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-001538-33
    A.3Full title of the trial
    A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study will look at whether the study drug Tepotinib works to stop the regrowth of your lung cancer. The study drug will be used in combination with an approved lung cancer medication called osimertinib,which is an EGFR inhibitor.
    This is a Phase II study, which means that the study drug has already been tested in a small number of people in previous clinical research studies.Only patient who have progressed on first-line osimertinib due to MET amplification will be enrolled in the study
    A.3.2Name or abbreviated title of the trial where available
    Tepotinib plus osimertinib in EGFR TKI relapsed
    A.4.1Sponsor's protocol code numberMS200095-0031
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03940703
    A.5.4Other Identifiers
    Name:IND NumberNumber:128073
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/279/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Healthcare 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 Healthcare 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 Film-coated 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.3.9.1CAS number 1100598-30-8
    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 number250
    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 Yes
    D.2.1.1.1Trade name TAGRISSO
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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 INNosimertinib
    D.3.9.1CAS number 1421373-65-0
    D.3.9.3Other descriptive nameOSIMERTINIB
    D.3.9.4EV Substance CodeSUB176340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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: 3
    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 TAGRISSO
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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 INNosimertinib
    D.3.9.1CAS number 1421373-65-0
    D.3.9.3Other descriptive nameOSIMERTINIB
    D.3.9.4EV Substance CodeSUB176340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Locally advanced or metastatic NSCLC histology (confirmed by either histology or cytology) with documented activating mutation of the EGFR receptor including T790M status
    Resistance on previous first line osimertinib
    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 combined with osimertinib in
    participants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of tepotinib combined with osimertinib in
    participants with advanced or metastatic EGFRm+ NSCLC and MET
    amplification determined centrally by blood-based next generation
    sequencing.
    To assess the efficacy of tepotinib monotherapy in participants with
    advanced or metastatic EGFRm+ NSCLC and MET amplification
    determined centrally by FISH.
    To assess tolerability and safety in participants with advanced or
    metastatic EGFRm+ NSCLC and MET amplification treated with the
    combination of tepotinib plus osimertinib.
    To assess tolerability and safety in participants with advanced or
    metastatic EGFRm+ NSCLC and MET amplification treated with tepotinib
    monotherapy.
    To further assess efficacy of tepotinib combined with osimertinib in
    participants with advanced or metastatic EGFRm+ NSCLC and MET
    amplification, determined centrally by FISH
    please refer to protocol for more information
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are ≥ 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 [ie, ≥ 20 years of age in Japan]), at the time of signing the informed consent.
    2. Are participants with the following:
    a) Locally advanced or metastatic NSCLC histology (confirmed by either histology or cytology) with documented activating EGFR mutation
    b) Presence of at least 1 independently verified measurable lesion in accordance with RECIST 1.1, that can be accurately assessed at baseline with ≥ 10 mm in the longest diameter (except lymph nodes which must Have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI), which is suitable for accurate repeated measurements and that preferably was not previously irradiated or biopsied
    c) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks
    d) Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria:
    -Radiological documentation of disease progression on first-line osimertinib.
    -Objective clinical benefit documented during previous osimertinib
    therapy, defined by either partial or complete radiological response, or
    durable stable disease (SD) (SD should last > 6 months) after initiation
    of osimertinib
    e) Have received only first line osimertinib as a prior line of therapy in
    the noncurative advanced or metastatic NSCLC setting
    f) MET amplification as determined by either FISH testing (central or
    local) on tumor tissue (TBx) or central blood-based next generation
    sequencing (LBx). Tumor and blood samples must be collected following
    progression on prior first-line osimertinib at Prescreening.
    -Submission of tumor tissue and blood sample obtained after
    progression on first line osimertinib, is mandatory for all patients for
    MET amplification testing.
    -Submission of tumor tissue during Prescreening or Screening is
    mandatory for patients with tumor tissue tested by local FISH, to
    confirm MET amplification status. Central confirmation is not mandated
    prior to the start of study treatment.

    3.Woman no WOBCP, or, use a highly effective contraception. Man: Contraception or no intercourse with a WOBCP1.
    E.4Principal exclusion criteria
    1. Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention. Prior radiotherapy or surgery for brain metastases such as stereotactic radiosurgery/gammaknife must have been completed ≥ 2 weeks, all others ≥ 4 weeks prior to start of therapy. Participants with leptomeningeal disease are ineligible.
    2. Any unresolved toxicity Grade 2 or more according to NCI-CTCAE version 5, from previous anticancer therapy with the exception of alopecia.
    3. Need for transfusion within 14 days prior to the first dose of study intervention.
    4. Participants who have brain metastasis as the only measurable lesion
    5. Inadequate hematological function:
     Hemoglobin < 8.5 g/dL
     Neutrophils < 1.5 × 109/L
     Platelets < 100 × 109/L.
    6. Inadequate liver function:
     Total bilirubin > 1.5 × ULN
     AST/ALT/ALP > 3 × ULN
     For participants with liver metastases:
    i. Total bilirubin > 1.5 × ULN
    ii. AST/ALT/ALP > 5 × ULN
    iii. For participants with bone metastases: ALP > 5 × ULN.
    7. Inadequate renal function:
     Renal impairment as evidenced by serum creatinine  1.5 × ULN, or creatinine clearance (CrCl) < 30 mL/min calculated by the Cockcroft-Gault formula (24-hour CrCl might be requested by the Investigator for confirmation, if calculated CrCl is < 50 mL/min. In such case, participants with 24-hour CrCl < 30 mL/min should be excluded).
    CrCl (mL/min) = [(140 – age(year)) × weight(kg)] 72 × serum creatinine (mg/dL) {× 0.85 for females}
    8. History of ILD or interstitial pneumonitis including radiation pneumonitis that required steroid treatment.
    9. Impaired cardiac function:
     Left ventricular ejection fraction < 45% defined by echocardiography
     Grade 4 arrhythmia (NCI-CTCAE v5.0) Unstable angina pectoris
     Congestive Heart Failure New York Heart Association III and IV
     Myocardial infarction, stroke, or transient ischemic attack within the last 6 months prior to study entry.
    10. Corrected QT interval by Fredericia (QTcF) > 470 ms for women and > 450 ms for men at screening.
    Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.
    11. Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg).
    12. Contraindication to the administration of osimertinib.
    13. Medical history of liver fibrosis/cirrhosis.
    14. Past or current history of neoplasm other than NSCLC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, benign prostate neoplasm/hypertropia, or other cancer curatively treated and with no evidence of disease for at least 5 years.
    15. Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
    16. Major surgery within 28 days prior to Day 1 of study intervention.
    17. Known human immunodeficiency virus positivity.
    18. Known hypersensitivity to any of the study intervention ingredients.
    19. Has not received an EGFR-TKI containing treatment directly prior to enrollment into the study, ie, chemotherapy or checkpoint inhibitor treatment with/without vascular endothelial growth factor inhibitors either in monotherapy or in combination are allowed, if these treatments do not represent the most recent treatment lines prior to enrollment
    20. Prior treatment with other agents targeting the HGF/MET pathway such as crizotinib, capmatinib, savolitinib, foretinib, glesatinib, cabozantinib, merestinib, onartuzumab, rilotumumab, emibetuzumab, and ficlatuzumab.
    21. Participants currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of study intervention) medications or herbal supplements known to be potent inducers of CYP3A4.
    22. Participation in another interventional clinical study (except those participants who were solely involved in other studies where the investigational product was osimertinib in the first-line of therapy within the 30 days prior to randomization/first dose.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response (confirmed complete response [CR] or partial response [PR]) determined according to Response Evaluation Criteria in Solid Tumors
    (RECIST) Version 1.1 as per Independent Review Committee (IRC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycles of 21 days until disease progression (according to RECIST Version 1.1), death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.
    E.5.2Secondary end point(s)
    Objective response (CR or PR) determined according to RECIST Version 1.1 as per IRC.
    Occurrence of Adverse Events (AEs) and treatment related AEs.
    Occurrence of abnormalities (Grade ≥ 3) in laboratory test values (hematology and coagulation, biochemistry) and urinalysis.
    Occurrence of markedly abnormal vital sign measurements, change in body weight, and Eastern
    Cooperative Oncology Group (ECOG) performance status.
    Occurrence of clinically significantly abnormal electrocardiograms (ECGs).
    Objective response according to RECIST Version 1.1 assessed by Investigator.
    Confirmed CR assessed by IRC and by Investigator.
    Duration of response assessed from CR or PR until progressive disease (PD), death, or last tumor assessment assessed by IRC
    and by Investigator.
    Disease control (confirmed CR + PR or stable disease [SD] lasting at least 12 weeks) as assessed by
    IRC and by Investigator.
    Progression free survival time according to RECIST Version 1.1 by IRC and by Investigator.
    Overall survival.
    Patient-reported outcomes/health-related quality of life as reported using the following:
     EuroQol Five Dimension Five Level Scale
     European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30
    Non–small Cell Lung Cancer Symptom
    Assessment Questionnaire.
    Single- and multiple-dose PK profile of osimertinib, tepotinib, and their metabolites including but not limited to AUC0-t, Cmax, and tmax after first dose (Day
    1) and after multiple study intervention dose administrations (Day 15) (safety run-in).
    Population PK profile of osimertinib, tepotinib, and their metabolites, including, but not limited to, CL/f and VZ/f based on sparse PK sampling on Day 1,
    Cycle 1 and 2.
    Mutation status in EGFR and other pathways
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuous
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    China
    Hong Kong
    Japan
    Korea, Republic of
    Malaysia
    Philippines
    Russian Federation
    Singapore
    Taiwan
    Thailand
    Turkey
    United States
    Viet Nam
    Belgium
    France
    Germany
    Netherlands
    Spain
    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 study is defined as the date of study intervention discontinuation by all participants (due to either disease progression, undue toxicity, or withdrawal, and, therefore, are not likely to benefit from tepotinib any longer) and two thirds of the participants have died or were followed up for at least 3 years, whatever occurs first. After the end of the study a final analysis, including an analysis of efficacy and safety, will be conducted in all participants.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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, people in emergency situation
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 122
    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)
    anti-cancer treatments to discuss with the doctor
    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 Decision2019-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-07
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA