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    Summary
    EudraCT Number:2013-001699-39
    Sponsor's Protocol Code Number:HER117158
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001699-39
    A.3Full title of the trial
    A phase I, first time in human, open-label, dose escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of anti-HER3 monoclonal antibody GSK2849330 in subjects with advanced HER3-positive solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 study of anti-HER3 monoclonal antibody GSK2849330, in subjects with advanced HER3-positive solid tumors.
    A.4.1Sponsor's protocol code numberHER117158
    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 SponsorGlaxoSmithKline Research Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline
    B.4.2CountryAustralia
    B.4.1Name of organisation providing supportGlaxoSmithKline
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportGlaxoSmithKline
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 4466
    B.5.5Fax number+44208990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameGSK2849330
    D.3.2Product code GSK2849330
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK2849330
    D.3.9.3Other descriptive nameGSK2849330 Solution for Infusion, 100 mg/mL
    D.3.9.4EV Substance CodeSUB130968
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with advanced HER3-positive solid tumors
    E.1.1.1Medical condition in easily understood language
    Confirmed diagnosis of a HER3 positive tumor of one of the following cancers for which no standard treatment alternatives exist:
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10033575
    E.1.2Term Pancreas cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10053571
    E.1.2Term Melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    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
    To determine the safety and tolerability of GSK2849330 in subjects with advanced HER3- positive solid tumors.
    E.2.2Secondary objectives of the trial
    To characterize the PK of GSK2849330 following IV administration.

    To evaluate preliminary evidence of target engagement and PD effects of GSK2849330

    To determine the recommended dose regimen(s) of GSK2849330 for further exploration in Part 2.

    To evaluate the immunogenicity of GSK2849330 following IV administration.

    To evaluate preliminary evidence of clinical benefit in Part 2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Inclusion criteria please view the following sections within the protocol.

    For Pre-screening Inclusion Criteria for Part 1 & 2 see protocol section 5.2.1 -5.2.2. P 60-61.

    For Screening Inclusion Criteria for Parts 1 and 2 see below
    1. Males and females ≥18 years of age (at the time consent is obtained).
    2. Written informed consent provided.
    3. For subjects enrolled in Part 1:subjects must have tumors with documented HER3 expression (2+ or 3+) on the cell surface of the invasive component of the tumor (either on archival tissue or fresh tumor biopsy) using an analytically validated IHC assay by central laboratory (see protocol section 7.6.1.1 for details). Subjects enrolled in Part 2 must meet inclusion criterion 9 listed below.
    4. ECOG performance status of 0 or 1 (see protocol Appendix 3).
    5. Adequate baseline organ function defined by: Please see table for further information.
    6. If the subject is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, as defined in protocol Section 11.1.1, from the time of the first dose of study treatment until 45 days or 5 half-lives (whichever is longer) after the last dose of study treatment.
    7. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in Section 11.1.2 from the time of the first dose of study treatment until 45 days or 5 half-lives (whichever is longer) after the last dose of study treatment to allow for clearance of GSK2849330 in seminal fluid.
    8. Subjects enrolled as part of the PK/PD cohort (Part 1) must agree to undergo preand on-treatment tumor biopsies.

    For Inclusion Criteria for Part 2 ONLY section 5.2.4. of the protocol
    As listed above for Part 1, with the exception of criterion 3 which should be replaced with the following criterion 9 and the addition of criteria 10 and 11.
    9. For Group 1: subjects with previously treated, unresectable stage III
    or IV melanoma with documented HER3 expression (3+) on the cell
    surface of the invasive component of the tumor (either on archival
    tumor or fresh tumor biopsy) using an analytically validated IHC
    assay by central laboratory.
    - Subjects must have no more than 3 prior lines of systemic regimens
    and have disease progression on or after last prior treatment (based
    on RECIST v1.1).
    - Subjects with BRAF V600 mutations who already received or were
    intolerant of prior BRAF inhibitor therapy may be included. BRAF
    V600 inhibitor-naïve subjects will be eligible if a BRAF inhibitor is not
    available to them commercially or via a clinical trial.
    - Subjects may be included if they had prior immune therapy, were
    intolerant of prior immune therapy, or if such therapy is not available to
    them commercially or via a clinical trial.
    For Group 2: Subjects with previously treated, unresectable stage III or IV gastric or gastroesophageal junction (GEJ) adenocarcinoma with documented HER3 expression (3+) on the cell surface of the invasive component of the tumor (either on archival tumor or fresh tumor biopsy) using an analytically validated IHC assay by central laboratory.
    - Subjects must have no more than 3 prior lines of systemic regimens
    and have disease progression on or after last prior treatment (based
    on RECIST v1.1).
    - Subjects with HER2 positive disease may be included if they had prior
    anti-HER2 therapy or were intolerant of prior anti-HER2 therapy or if
    such therapy is not available to them commercially or via a clinical
    trial.
    For Group 3: Subjects with previously treated, unresectable stage III or
    IV cancers of the head and neck with documented HER3 expression
    ( ≥ 1+) and NRG1 expression on the cell surface of the tumor (either
    on archival tumor or fresh tumor biopsy) using analytically validated
    assays by central laboratory.
    - Subjects must have no more than 3 prior lines of systemic therapy
    and have disease progression on or after last prior treatment (based
    on RECIST v1.1).
    - Subjects with locoregional recurrences amenable to definite surgery or
    additional radiation are excluded.
    For Group 4: Subjects with previously treated, unresectable stage III
    or IV NSCLC with documented HER3 expression ( ≥1+) and NRG1
    expression on the cell surface of the tumor (either on archival tumor
    or fresh tumor biopsy) using analytically validated assays by central
    laboratory.
    - Subjects must have no more than 3 prior lines of systemic regimens
    and have disease progression on or after last prior treatment (based
    on RECIST v1.1).

    For further information please view Protocol P64.
    E.4Principal exclusion criteria
    1. Subjects with leptomeningeal or brain metastases or spinal cord compression.
    - Subjects with untreated brain or meningeal metastases are not eligible
    (computed tomography [CT] scans are not required to rule this out
    unless there is a clinical suspicion of central nervous system [CNS]
    disease).
    - Subjects with treated and radiologic or clinical evidence of stable brain
    metastases (confirmed by 2 scans at least 4 weeks apart), with no
    evidence of cavitation or hemorrhage in the brain lesion are eligible
    providing that they are asymptomatic and do not require
    corticosteroids. Subjects are not permitted to receive enzyme inducing
    anti-epileptic drugs.
    2. Prior HER3- directed treatment (HER2- or EGFR-directed treatment is
    acceptable).
    3. Use of an investigational anti-cancer drug within 28 days (or 5 half
    -lives, whichever is longer) preceding the first dose of GSK2849330
    OR chemotherapy within the last 3 weeks (6 weeks for prior
    nitrosourea or mitomycin C) OR any major surgery, radiotherapy, immunotherapy or any other anti-cancer therapy within the last
    4 weeks, except as noted above.
    4. Unresolved toxicity greater than NCI-CTCAE, version 4.0 [NCI, 2009]
    Grade 1from previous anti-cancer therapy except alopecia and stable
    anemia (i.e.,untransfused Hb ≥9.0 g/dL without the need for supportive transfusion within 2 weeks of screening) at the time of treatment
    allocation.
    5. Known or suspected hypersensitivity reaction to prior biologic
    therapy (e.g., therapeutic monoclonal antibody) that in the opinion
    of the investigator is a contraindication to their participation in
    the study.
    6. Current use of a prohibited medication or requires any of these medications
    during treatment (protocol Section 10.2).
    7. History or evidence of significant cardiovascular risk including any of
    the following:
    - LVEF <50%
    -A QT interval corrected for HR (QTc) ≥ 480 msec (≥500 msec for subjects
    with bundle branch block)
    - History or evidence of current clinically significant uncontrolled
    arrhythmias.
    Exception: Subjects with controlled atrial fibrillation for >30 days
    prior to enrollment are eligible.
    - History of acute coronary syndromes (including myocardial infarction
    and unstable angina), coronary angioplasty, or stenting within 6 months
    prior to enrollment.
    - History or evidence of current ≥ Class II congestive heart failure as
    defined by New York Heart Association (NYHA).
    8. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV),
    or hepatitis C virus (HCV) infection (with the exception of chronic or
    cleared HBV and HCV infection which will be allowed).
    9. Evidence of another active malignancy (excludes non-melanoma skin cancer). Consult GSK Medical Monitor if unsure whether second
    malignancies meet requirements specified above.
    10. Psychological, familial, sociological, or geographical conditions
    that do not permit compliance with the protocol.
    11. Concurrent medical condition that in the investigator’s opinion
    would jeopardize compliance with the protocol.
    12. Lactating female.
    13. Receiving chronic immunosuppressive therapies (includes daily
    steroid doses in excess of 20 mg/day of prednisone).
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints: AEs, serious adverse events (SAEs), DLTs, and changes in laboratory values, electrocardiograms (ECGs), and vital signs
    E.5.1.1Timepoint(s) of evaluation of this end point
    o AEs and SAEs on a continuous basis
    o DLTs within first 28 days
    o Chemistry and Hematology is at every infusion
    o Urinalysis every 4 weeks
    o ECG is at every 2weeks in the first months then every 4 weeks.
    o Vital signs at every infusion
    E.5.2Secondary end point(s)
    o PK parameter values for GSK2849330.
    o Total and phospho-HER3 from tumor tissue.
    o Safety, tolerability, PK, and available PD data.
    o Antibodies to GSK2849330 assessed in serum.
    o Overall response rate (ORR), tumor markers, and other
    measures of clinical benefit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    o PK sampling every week in the first 12 weeks then every 12 weeks. In Part 2: PK sampling every 2 weeks in the first 12 weeks then every 12 weeks.
    o Tumor tissue prestudy, D15 and discontinuation.
    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 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 Yes
    E.8.1.7.1Other trial design description
    dose-escalation study
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Netherlands
    United States
    E.8.7Trial has a data monitoring committee No
    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.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 77
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 77
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 154
    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)
    The investigator is responsible for ensuring that consideration has been given for the post-study care of the subject’s medical condition whether or not GSK is providing specific post-study 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 Decision2015-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    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.

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