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    Summary
    EudraCT Number:2016-002017-22
    Sponsor's Protocol Code Number:63723283LUC1001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-12-21
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-002017-22
    A.3Full title of the trial
    A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first-in-human study to evaluate the clinical activity of JNJ-63723283 in patients with advanced cancers.
    A.4.1Sponsor's protocol code number63723283LUC1001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02908906
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71524 21 66
    B.5.5Fax number+31(0)71524 21 60
    B.5.6E-mailClinicalTrialsEU@its.jnj.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.3.2Product code JNJ-63723283
    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 INNNot Assigned
    D.3.9.1CAS number Not Assigned
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.3Other descriptive nameJNJ-63723283-AAA
    D.3.9.4EV Substance CodeSUB183887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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.3.2Product code JNJ-63723283
    D.3.4Pharmaceutical form Lyophilisate 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 INNNot Assigned
    D.3.9.1CAS number Not Assigned
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.3Other descriptive nameJNJ-63723283-AAA
    D.3.9.4EV Substance CodeSUB183887
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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
    Advanced Stage Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Advanced Stage Solid Tumors
    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 LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To identify the recommended Phase 2 dose(s) (RP2D[s]) for JNJ-63723283 (Part 1)
    • To assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in
    subjects with selected advanced cancers including non-small cell lung
    cancer (NSCLC), melanoma, renal, bladder, small cell lung cancer
    (SCLC), gastric/esophageal cancer, and high-level microsatellite instability
    (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) (Part 2)
    E.2.2Secondary objectives of the trial
    • To characterize the safety of JNJ-63723283 in subjects with advanced solid tumors
    • To characterize the pharmacokinetics of JNJ-63723283 administered intravenously
    • To assess the immunogenicity of JNJ-63723283
    • To assess the clinical activity of JNJ-63723283
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥ 18 years of age
    2. Have evaluable disease,
    2a. For Part 2, at least 1 measurable lesion that can be accurately
    assessed at baseline by CT (or magnetic resonance imaging [MRI] where
    CT is contraindicated) and is suitable for repeated assessment as per
    RECIST v1.1
    3.1. Criterion modified per Amendment 2
    3.2. Criterion modified per Amendment 3
    3.3. Type of cancer:
    Part 1 of the study:
    Has any type of advanced or refractory solid tumor malignancy, except
    lymphoma, that is metastatic or unresectable and previously received or
    was ineligible for standard treatment options including appropriate
    molecularly targeted therapies (eg, subjects with epidermal growth
    factor receptor [EGFR] mutant NSCLC or with NSCLC with anaplastic
    lymphoma tyrosine kinase [ALK] rearrangement).
    Part 2 of the study:
    Histologically or cytologically confirmed diagnosis of 1 of the following
    unresectable Stage III or IV solid tumor malignancies and previously
    received or was ineligible for standard treatment options including
    appropriate molecularly targeted therapies (eg, subjects with EGFR
    mutant NSCLC or with NSCLC with ALK rearrangement):
    • NSCLC
    - PD-L1-high tumor sample (≥50% tumor cells stained positive for PDL1)
    by a PD-L1 immunohistochemistry (IHC) test performed by a local
    laboratory or by the central laboratory designated by the sponsor
    NOTE: Subjects with EGFR mutant or other molecular aberration who
    progress on appropriate molecular targeted therapy do not require prior
    treatment with platinum-containing chemotherapy.
    • Bladder cancer (urothelial carcinoma)
    • Renal cell carcinoma
    • Gastric/esophageal carcinoma
    • Melanoma
    • SCLC
    • MSI-H or dMMR CRC
    - MSI-H or dMMR by a polymerase chain reaction (PCR), next
    generation sequencing, or IHC test performed by a local laboratory or by
    the central laboratory designated by the sponsor Progressed following
    treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
    • Thymoma, including thymic carcinoma
    4. Have an Eastern Cooperative Oncology Group [ECOG] performance
    status 0 or 1 (Attachment 1)
    5.1. Criterion modified per Amendment 2
    5.2. Have organ and bone marrow function as follows without blood
    6. Criterion modified per Amendment 2
    6.1. Has thyroid function laboratory values within normal range. Note: If
    thyroid stimulating hormone (TSH) is not within normal limits, the
    subject may still be eligible if T3 (either total or free) and free T4 are
    within normal limits.
    7. Women of childbearing potential must have a negative serum
    pregnancy test at Screening using highly sensitive pregnancy test.
    8. Willing to use contraceptive methods consistent with local regulations
    for subjects participating in clinical studies during and after the study
    until 5 months after the last dose of study drug.
    a. Women of childbearing potential must agree to use 2 highly effective
    methods of contraception consistent with local regulations (<1% per
    year failure rate when used consistently and correctly).
    b. A man who is sexually active with a woman of childbearing potential
    and has not had a vasectomy must agree to use a barrier method of birth
    control.
    c. Women and men must agree not to donate sperm or eggs (ova,
    oocytes), respectively, during the study and after the study until 5
    months after the last dose of study drug.
    9. Willing and able to adhere to the prohibitions and restrictions
    specified in this protocol.
    10. Each subject (or their legally acceptable representative) must sign
    an informed consent form (ICF) indicating that he or she understands
    the purpose of and procedures required for the study and are willing to
    participate in the study. Consent is to be obtained prior to the initiation
    of any study-related tests or procedures that are not part of standard of
    care for the subject's disease.
    11. Subjects enrolled into Part 2 must have tumor tissue available for
    correlative studies. Fresh tumor biopsy is preferred. Archival tissue must
    meet the following criteria: archival sections within 4 months of
    sectioning that have been stored at 2° to 8° C in the dark or archival
    tumor blocks within 5 years of collection. Subjects without tissues
    meeting the aforementioned archived tissue criteria must undergo a
    fresh biopsy.
    E.4Principal exclusion criteria
    1. Has uncontrolled intercurrent illness, including but not limited to
    ongoing or active infection requiring IV antibiotics, symptomatic
    congestive heart failure (New York Heart Association class III-IV;
    Attachment 2), unstable angina pectoris, cardiac arrhythmia, poorly
    controlled hypertension or diabetes, or psychiatric illness/social
    situation that would limited compliance with study requirements
    2. Has had prior treatment with an anti-PD-1 antibody, anti-PD-L1
    antibody or anti-PD-L2 antibody
    3. Treatment with any local or systemic anti-neoplastic therapy,
    radiotherapy (excluding limited palliative radiation), or investigational
    anticancer agent within 14 days or 4 half-lives, whichever is longer, up
    to a maximum wash-out period of 28 days prior to the initiation of study
    drug administration.
    4. Criterion modified per Amendment 2
    4.1. Has brain or leptomeningeal metastases unless asymptomatic, have
    been treated, have been stable for >4 weeks as documented by
    radiographic imaging with no evidence of cavitation or hemorrhage in
    the brain lesion, and do not require prolonged (>2 weeks) systemic
    corticosteroid therapy. Subjects are not permitted to receive enzymeinducing
    antiepileptic drugs.
    5. Has not recovered (ie, ≤Grade 1 or baseline) from AEs except
    alopecia, peripheral neuropathy related to prior anticancer therapy and
    stable anemia (ie, untransfused Hb ≥8.5 g/dL without the need for
    supportive transfusion within 2 weeks of screening) at the time of
    treatment allocation
    6. Criterion modified per Amendment 2
    6.1. Has an active autoimmune disease or a documented history of
    autoimmune disease that requires systemic steroids or
    immunosuppressive agents. Note: Subjects with vitiligo or resolved
    childhood asthma/atopy would be an exception to this rule. Subjects
    that require intermittent use of bronchodilators or local steroid
    injections would not be excluded from the study. Subjects with
    hypothyroidism stable on hormone replacement will not be excluded
    from the study. Subjects with a history of transient autoimmune
    manifestations of an acute infectious disease that resolved upon
    treatment of the infectious agent (eg, acute Lyme arthritis) will not be
    excluded from the study.
    7. Grade 3 or higher toxicity effects from previous treatment with
    immunotherapy
    8. Known allergies, hypersensitivity, or intolerance to protein-based
    therapies or with a history of any significant drug allergy (such as
    anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or
    anemia), or to JNJ-63723283 excipients (refer to Investigator's
    Brochure)
    9. Has taken immunosuppressive doses of systemic medications such as
    corticosteroids (doses >10 mg/day prednisone or equivalent), within 2
    weeks before the planned first dose of study drug
    10. A woman who is pregnant, breast-feeding, or planning to become
    pregnant while enrolled in this study or within 5 months after the last
    dose of study drug
    11. A man who plans to father a child while enrolled in this study or
    within 5 months after the last dose of study drug.
    12. Has any condition for which, in the opinion of the investigator,
    participation would not be in the best interest of the subject (eg,
    compromise the well-being) or that could prevent, limit, or confound the
    protocol-specified assessments
    13. Had major surgery (eg, requiring general anesthesia) within 4 weeks
    before dosing, or will not have fully recovered from surgery, or has
    surgery planned during the time the subject is expected to participate in
    the study or within 4 weeks after the last dose of study drug
    administration.
    14. Criterion modified per Amendment 2
    14.1. Active or chronic hepatitis B or hepatitis C disease as determined
    by hepatitis B surface antigen (HBsAg), hepatitis B core antibody, or
    hepatitis C antibody (anti-HCV) positivity at screening. If positive,
    further testing of quantitative levels to rule out active infection is
    required.
    15. Has a history of human immunodeficiency virus (HIV) antibody
    positive, or tests positive for HIV at Screening
    16. Criterion modified per Amendment 2
    16.1. Vaccinated with a live vaccine within 28 days prior to the first dose
    of study drug. Annual inactivated influenza vaccine is permitted.
    E.5 End points
    E.5.1Primary end point(s)
    • Frequency and severity of dose-limiting toxicity (DLT)
    • Overall response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects with selected advanced solid tumors
    E.5.1.1Timepoint(s) of evaluation of this end point
    - The DLT evaluation period is defined as 2 weeks from the start of the first JNJ-63723283 infusion.
    - Every 8 weeks (+/-2 weeks window) until Week 24 then every 12 weeks (+/-2 weeks window) relative to the date of first dose, and regardless of dose or schedule
    E.5.2Secondary end point(s)
    • Safety profile of JNJ-63723283 (safety parameters include but are not limited to the frequency and severity of adverse events [AEs] and immune-related AEs [irAEs], vital signs measurements, clinical laboratory values, and electrocardiograms [ECGs])
    • Serum JNJ-63723283 pharmacokinetic parameters including but not limited to maximum observed serum concentration (Cmax), area under the concentration-time curve between 2 defined sampling points, t1 and t2 (AUCt1-t2), half-life (T1/2), total systemic clearance of drug after IV administration (CL), volume of distribution at steady-state (Vss), and accumulation ratio (R)
    • Presence of anti-JNJ-63723283 antibodies and effect on serum JNJ-63723283 concentrations
    • ORR per the Immune-Related Response Criteria (irRC), duration of response (DOR), progression-free survival (PFS) by both RECIST v.1.1 and irRC, and OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The Safety profile of JNJ-63723283 will be evaluated throughout the whole study
    - Serum pharmacokinetic parameters defined above will be evaluated throughout the whole study
    - The presence of anti-JNJ-63723283 antibodies and effect on serum concentrations will be evaluated throughout the whole study
    - OSS, DOR, PFS and OS will be evaluated at the end of the study
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Biomarker
    Exploratory
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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.8.3 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 EEA26
    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
    Italy
    Poland
    Russian Federation
    Spain
    United Kingdom
    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
    The end of the study is defined as last study assessment for the last subject on study or anytime the sponsor terminates the study, whichever comes first.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 101
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 229
    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)
    None
    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 Decision2017-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-05
    P. End of Trial
    P.End of Trial StatusOngoing
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