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    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).

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    Summary
    EudraCT Number:2010-023783-41
    Sponsor's Protocol Code Number:E7080-G000-303
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-023783-41
    A.3Full title of the trial
    A Multicenter, Randomized, Double- Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I- Refractory Differentiated Thyroid Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 trial studying how well E7080 works in treating patients with advanced thyroid cancer who no longer gain benefit from radioactive iodine therapy. The trial is taking place worldwide, patients and their physician do not know if they are receiving the active drug or a dummy drug.
    A.4.1Sponsor's protocol code numberE7080-G000-303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01321554
    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 SponsorEisai Limited
    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 supportEisai Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408456761400
    B.5.5Fax number+4408456761401
    B.5.6E-mailLMedInfo@eisai.net
    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/3/13/1119 and EU/3/13/1121
    D.3 Description of the IMP
    D.3.1Product nameE7080
    D.3.2Product code E7080
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenvatinib
    D.3.9.2Current sponsor codeE7080
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 nameE7080
    D.3.2Product code E7080
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenvatinib
    D.3.9.2Current sponsor codeE7080
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    131I-refractory differentiated thyroid cancer (DTC)
    E.1.1.1Medical condition in easily understood language
    Advanced thyroid cancer which no longer responds to radioactive iodine therapy.
    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 10055107
    E.1.2Term Thyroid cancer metastatic
    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 compare the progression-free survival of subjects with 131I-refractory differentiated thyroid cancer with radiographic evidence of disease progression within the prior 12 months treated with E7080 versus placebo.
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES

    To compare overall response rates (ORR) (Complete and partial responses, CR and PR) of subjects treated with E7080 versus placebo.

    To compare overall survival of subjects treated with E7080 versus placebo.

    To compare safety and tolerability of E7080 versus placebo.

    To assess the pharmacokinteic (PK) profile of E7080 in subjects with 131I-refractory differentiated thyroid cancer.

    EXPLORATORY OBJECTIVES

    To compare Disease Control rate (DCR) (CR, PR, or stable disease [SD]), Clinical Benefit Rate (CBR) (CR, PR + durable SD) and durable SD (duration of SD ≥ 23 weeks) of subjects treated with E7080 versus Placebo.

    To identify and validate blood and tumor biomarkers which correlate with efficacyrelated endpoints of this study.

    To identify and validate DNA-sequence variants in genes influencing E7080 absorption, distribution, metabolism, excretion (ADME).

    To assess safety and efficacy in the Optional Open Label treatment period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must have histologically or cytologically confirmed diagnosis of one of the following DTC subtypes:

    a. PTC
    i. Follicular variant
    ii. Variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin’s-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated)
    b. FTC
    i. Hürthle cell
    ii. Clear cell
    iii. Insular

    2. Measurable disease meeting the following criteria and confirmed by central radiographic review:
    a. At least 1 lesion of ≥1.0 cm in the longest diameter for a non-lymph node or ≥1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of ≥1.5 cm
    b. Lesions that have had EBRT or loco-regional therapies such as RF ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion

    3. Subjects must show evidence of disease progression within 12 month

    4. Subjects must be 131I-refractory/resistant as defined by at least one of the following:
    a. One or more measurable lesions that do not demonstrate iodine uptake on any radioiodine scan
    b. One or more measurable lesions that has progressed by RECIST 1.1 within 12 months of 131I therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or post-treatment scanning. These subjects must not be eligible for possible curative surgery.
    c. Cumulative activity of 131I of >600 mCi or 22 GBq, with the last dose administered at least 6 months prior to study entry

    5. Subjects may have received 0 or 1 prior VEGF / VEGFR-targeted therapy. Each of the VEGF/VEGFR targeted agents will be counted individually

    6. Patients with known brain metastases who have completed whole brain radiotherapy, stereotactic radiosurgery or complete surgical resection, will be eligible if they have remained clinically stable, asymptomatic and off of steroids for one month

    7. Subjects must be receiving thyroxine suppression therapy and TSH should not be elevated. When tolerated by the subject, thyroxine dose should be changed to achieve TSH suppression and this dose can be changed concurrently upon starting E7080

    8. All chemotherapy or radiation-related toxicities must have resolved to <Grade 2 severity, except alopecia and infertility

    9. Subjects must have an ECOG Performance Status of 0−2

    10. Adequately controlled blood pressure with or without antihypertensive medications,defined as BP=<150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1

    11. Adequate renal function defined as calculated creatinine clearance ≥30 mL/min per the Cockcroft and Gault formula

    12. Adequate bone marrow function: a. ANC ≥1500/mm3 b. Platelets ≥100,000/mm3 c. Hemoglobin ≥9.0 g/dL

    13. Adequate blood coagulation function as evidenced by an INR ≤1.5

    14. Adequate liver function: a. Bilirubin ≤1.5 × the ULN except for unconjugated hyperbilirubinemia or Gilbert’s syndrome b. Alkaline phosphatase, ALT and AST ≤3 × the ULN. If alkaline phosphatase is >3 × ULN (in absence of liver metastases) or >5 × ULN (in presence of liver metastases) AND the subject also is known to have bone metastases, the liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of total alkaline phosphatase

    15. Males or females age ≥18 years

    16. Females must not be lactating or pregnant at Screening or Baseline

    17. All females will be considered to be of CBP unless they are postmenopausal or have been sterilized surgically at least 1 month before dosing

    18. Females of CBP must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a doublebarrier method, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the subject must agree to use a double-barrier method as described above if she becomes sexually active during study or 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation

    19. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above.

    20. Voluntary agreement to provide informed consent and the willingness and ability to comply with all aspects of the protocol.
    E.4Principal exclusion criteria
    1. Anaplastic or Medullary carcinoma of the thyroid

    2. Two or more prior VEGF / VEGFR-targeted therapies or any ongoing treatment for 131Irefractory DTC other than TSH-suppressive thyroid hormone therapy

    3. Prior treatment with E7080

    4. Subjects who have received any anti-cancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug and should have recovered from any toxicity related to previous anti-cancer treatment. This does not apply to the use of TSH-suppressive thyroid hormone therapy

    5. Major surgery within 3 weeks prior to the first dose of study drug

    6. Subjects having > 1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24h will be ineligible

    7. Gastrointestinal malabsorption, or any other condition in the opinion of the investigator that might affect the absorption of E7080

    8. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment

    9. Prolongation of QTc interval to > 480 msec

    10. Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring. (Treatment with low molecular weight heparin (LMWH) is allowed)

    11. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug

    12. Active infection (any infection requiring treatment)

    13. Active malignancy (except for differentiated thyroid carcinoma, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months

    14. Known intolerance to any of the study drugs (or any of the excipients)

    15. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

    16. Females who are pregnant or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for all subjects will be progression free survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of PFS will be performed when approximately 214
    progression events or deaths without disease progression have occurred in the study population, which is estimated to be approximately 29 months after the first subject is randomized.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are ORR as determined by blinded IIR using RECIST 1.1 and Overall Survival (OS).
    Exploratory Efficacy Endpoints are disease control rate (DCR), clinical benefit rate (CBR), and durable stable disease (SD) rate (duration of SD ≥ 23 weeks).
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR: CT/MRI neck/chest/abdomen/pelvis and other areas of known disease or newly suspected disease: at screening, every 8 weeks (Randomization Phase) once every 12 weeks and no less frequently than once every 24 weeks (Extension Phase); bone scan every 24 weeks. CT/MRI brain at screening and, if negative, to be repeated if clinically indicated, and within 1 week after a subject achieves a CR. For subjects with history of treated brain metastases, brain scans at screening and every 8 weeks
    OS: every 4 weeks
    PK: predose, 0.5-4 hours, and 6-10 hours postdose on C1D1 and C1D15, and predose and 2-12 hours postdose on C2D1. Subsequently, predose only on Day 1 of Cycles 3, 4, 5, and 6.
    AEs/SAEs: throughout the study. AEs and concomitant meds collected 30 days from last dose.
    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) 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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Czech Republic
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Spain
    Thailand
    Ukraine
    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
    Last patient, last visit.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 360
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects treated with lenvatinib who have not experienced disease progression may request to continue OOL lenvatinib at the same dose. Subjects taking placebo at the time of unblinding may be treated with
    lenvatinib in the OOL lenvatinib immediately or later at the time of progression. Subjects who leave the OOL phase due to disease progression (or the randomization phase but choose not to enter the
    OOL phase) will enter the Follow-up Period of the Extension Phase.
    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 Decision2011-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-14
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