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    Summary
    EudraCT Number:2017-002567-17
    Sponsor's Protocol Code Number:8951-CL-0301
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-002567-17
    A.3Full title of the trial
    A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-
    Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared with Placebo Plus mFOLFOX6 as First-line Treatment of Subjects with Claudin (CLDN)18.2-
    Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
    A.3.2Name or abbreviated title of the trial where available
    SPOTLIGHT
    A.4.1Sponsor's protocol code number8951-CL-0301
    A.5.4Other Identifiers
    Name:INDNumber: 129598
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc. (APGD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455878
    B.5.5Fax number+31715455224
    B.5.6E-mailcontacts@nl.astellas.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/803
    D.3 Description of the IMP
    D.3.1Product nameZolbetuximab (IMAB362)
    D.3.2Product code Zolbetuximab (IMAB362)
    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 INNZolbetuximab (recommended)
    D.3.9.1CAS number 1496553-00-4
    D.3.9.2Current sponsor codeIMAB362
    D.3.9.3Other descriptive nameIMAB362
    D.3.9.4EV Substance CodeSUB190351
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
    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 10001150
    E.1.2Term Adenocarcinoma gastric
    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 evaluate the efficacy of zolbetuximab plus mFOLFOX6 compared with placebo plus mFOLFOX6 (as first-line treatment) as measured by Progression Free Survival (PFS) in subjects with Claudin (CLDN)18.2
    positive, human epidermal growth factor receptor 2 (HER2)–negative locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma
    E.2.2Secondary objectives of the trial
    - To evaluate efficacy as measured by Overall Survival (OS) as a key secondary objective
    - To evaluate efficacy as measured by Objective Response Rate (ORR)
    - To evaluate efficacy as measured by Duration of Response (DOR)
    - To evaluate safety and tolerability of zolbetuximab
    - To evaluate health related quality of life (HRQoL) using the parameters
    as measured by European Organization for Research and Treatment of
    Cancer (EORTC) QLQ-C30, QLQ-OG25, Global Pain (GP) and the EuroQOL
    Five Dimensions Questionnaire 5L (EQ5D-5L) questionnaires
    - To evaluate the pharmacokinetics of zolbetuximab
    - To evaluate the immunogenicity profile of zolbetuximab
    - To evaluate efficacy as measured by Time to Progression (TTP)
    - To evaluate PFS following subsequent anti-cancer treatment (PFS2)
    - To evaluate Disease Control Rate (DCR)
    - To evaluate potential genomic and/or other biomarkers that may
    correlate with treatment outcome to zolbetuximab and mFOLFOX6.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Criteria:
    1.Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act
    [HIPAA] Authorization for US sites) must be obtained from the subject or legally authorized representative (if applicable) prior to any studyrelated procedures.
    2.Subject is considered an adult (e.g., ≥ 18 years of age in the US) according to local regulation at the time of signing the informed consent.
    3.Subject agrees not to participate in another interventional study while on study treatment.
    4.A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a
    demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:
    - Not a woman of childbearing potential (WOCBP) as defined in Appendix
    12.3 Contraception Requirements
    OR
    - WOCBP who agrees to follow the contraceptive guidance as defined in
    Appendix 12.3 Contraception Requirements throughout the treatment
    period and for at least 6 months after the final study drug
    administration.
    5.Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study treatment administration.
    6.Female subject must not donate ova starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
    7.A sexually active male subject with female partner(s) who are of childbearig potential must agree to use contraception as detailed in Appendix 12.3 Contraception Requirements during the treatment period
    and for at least 6 months after the final study drug administration.
    8.Male subject must not donate sperm starting at Screening and throughout the study period and for 6 months after the final study drug administration.
    9.Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time partner is breastfeeding throughout the study period and for
    6 months after the final study drug administration.
    Disease Specific Criteria:
    10.Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
    11.Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
    12.Subject has measurable disease according to RECIST 1.1 within 28 days prior to the first dose
    of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
    13.Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
    14.Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
    Physical or Laboratory Findings
    15.Subject has ECOG performance status 0 to 1.
    16.Subject has predicted life expectancy 12 weeks in the opinion of the investigator.
    17.Subject must meet all of the following criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment. In case of multiple central laboratory data within this period,
    the most recent data should be used to determine eligibility.
    a. Hemoglobin (Hgb) ≥ 9 g/dl. NOTE: Subject must not have received any growth factor or blood transfusions within 14 days prior to the hematology values obtained at screening. Subjects requiring
    transfusions to meet eligibility criteria are not eligible.
    b. Absolute neutrophil count ≥ 1.5 x 109/L
    c. Platelets ≥ 100 x 109/L
    d. Albumin ≥ 2.5 g/dL
    e. Total bilirubin < 1.5 x upper limit of normal (ULN)
    f. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
    g. Estimated creatinine clearance ≥ 30 mL/min
    h. Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy).

    E.4Principal exclusion criteria
    Prohibited Treatment or Therapies
    1.Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant
    chemotherapy as long as it was completed at least 6 months prior to the
    first dose of study treatment. Subject may have received treatment with
    herbal medications that have known antitumor activity > 28 days prior
    to first dose of study treatment.
    2.Subject has received radiotherapy for locally advanced unresectable or
    metastatic gastric or GEJ adenocarcinoma unless the radiotherapy was
    completed > 28 days prior to start of study treatment. Subject who
    received palliative radiotherapy to peripheral bone metastases 14 days
    prior to start of study treatment and has recovered from all acute
    toxicities is allowed.
    3.Subject has received systemic immunosuppressive therapy, including
    systemic corticosteroids within 14 days prior to first dose of study
    treatment. Subjects using a physiologic replacement dose of
    hydrocortisone or its equivalent (defined as up to 30 mg per day of
    hydrocortisone or up to 10 mg per day of prednisone) or a single dose of
    systemic corticosteroids are allowed.
    4.Subject has received other investigational agents or devices within 28
    days prior to first dose of study treatment.
    Medical History or Concurrent Disease
    5.Subject has prior severe allergic reaction or intolerance to known
    ingredients of zolbetuximab or other monoclonal antibodies, including
    humanized or chimeric antibodies.
    6.Subject has known immediate or delayed hypersensitivity, intolerance
    or contraindication to any component of study treatment.
    7.Subject has prior severe allergic reaction or intolerance to any
    component of mFOLFOX6.
    8.Subject has known dihydropyrimidine dehydrogenase deficiency
    (DPD). (NOTE: Screening for DPD deficiency should be conducted per
    local requirements.)
    9.Subject has gastric outlet syndrome or persistent/recurrent vomiting.
    10.Subject with recent gastric bleeding or symptomatic subjects with
    proven gastric ulcers that would exclude the subject from participation
    per investigator judgment.
    11.Subject has a known history of a positive test for human
    immunodeficiency virus (HIV) infection or known active hepatitis B
    (positive HBs Ag) or C infection. For subjects who are negative for HBs
    Ag, but HBc Ab positive, an HB DNA test will be performed and if positive
    the subject will be excluded. Subjects with positive serology but
    negative HCV RNA test results are eligible.
    12.Subject has an active autoimmune disease that has required systemic
    treatment within the past 2 years.
    13.Subject has active infection requiring systemic therapy that has not
    completely resolved within 14 days prior to start of study treatment.
    14.Subject has significant cardiovascular disease, including any of the
    following:
    a.Congestive heart failure (defined as New York Heart Association Class
    III or IV), myocardial infarction, unstable angina, coronary angioplasty,
    stenting, coronary artery bypass graft, cerebrovascular accident or
    hypertensive crisis within 6 months prior to administration of first dose
    of study drug.
    b.History of clinically significant ventricular arrhythmias (i.e., sustained
    ventricular tachycardia, ventricular fibrillation or Torsades de Pointes
    c.QTc interval > 450 msec for male subjects: QTc interval > 470 msec for
    female subjects
    d.History or family history of congenital long QT syndrome
    e.Cardiac arrhythmias requiring anti-arrhythmic medications (Subject
    with rate controlled atrial fibrillation for > 1 month prior to first dose of
    study drugs are eligible)
    15.Subject has known active central nervous system metastases and/or
    carcinomatous meningitis.
    16.Subject has known peripheral sensory neuropathy > Grade 1 unless
    the absence of deep tendon reflexes is the sole neurological abnormality.
    17.Subject has had a major surgical procedure ≤ 28 days prior to the start
    of study treatment.
    a. Subject is without complete recovery from a major survival procedure
    ≤ 14 days prior to the first dose of study treatment.
    18.Subject has psychiatric illness or social situations that would
    preclude study compliance, per investigator judgment.
    19.Subject has another malignancy for which treatment is required per
    investigator's clinical judgment.
    20.Subject has any concurrent disease, infection or comorbid condition
    that interferes with the ability of the subject to participate in the study,
    which places the subject at undue risk or complicates the interpretation
    of data in the opinion of the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS, which is defined as the time from the date of randomization until the date of radiological PD (per Response Evaluation Criteria In Solid Tumors [RECIST] 1.1 by independent review committee [IRC]) or death from any cause, whichever is earliest.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed when the protocol-defined number of PFS events have been observed.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    -OS, defined as the time from the date of randomization until the date of death from any cause
    -ORR, defined as the proportion of subjects who have a best overall response (BOR) of CR or PR as assessed by IRC per RECIST 1.1
    -DOR, defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest
    -Safety and tolerability, as measured by AEs, laboratory test results, vital signs, electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) performance status
    -HRQoL, as collected via EORTC QLQ-C30, QLQ-OG25, GP and EQ5D-5L questionnaires
    -Pharmacokinetics of IMAB362, Cmax and Ctrough
    -Immunogenicity of IMAB362 as measured by the frequency of anti-drug antibody (ADA) positive subjects.
    The exploratory endpoints are:
    -TTP, defined as the time from the date of randomization until the date of PD as assessed by IRC per RECIST 1.1.
    -PFS2, defined as the time from the date of randomization until the date of PD (per investigator) following subsequent anti-cancer therapy, death from any cause or start of any other anti-cancer therapy, whichever is earliest.
    -DCR, defined as the proportion of subjects who have a BOR of SD, CR or PR as assessed by IRC per RECIST 1.1.
    -Potential genomic and/or other exploratory biomarkers that may be related to treatment outcome of IMAB362
    -HRU
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoint analysis will be performed at the protocol defined primary PFS analysis and at the final OS analysis after 100% of the planned death events have been observed.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Australia
    Belgium
    Brazil
    Canada
    Chile
    China
    Colombia
    Costa Rica
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Poland
    Spain
    Taiwan
    United Kingdom
    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
    The end of study in all participating countries is defined as the last subject's last visit, or last contact.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days14
    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: 385
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 165
    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 161
    F.4.2.2In the whole clinical trial 550
    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)
    After the end of participation in the trial, patients will receive treatment according to current local medical practice.
    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 Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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