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    Summary
    EudraCT Number:2016-003352-67
    Sponsor's Protocol Code Number:E7389-G000-213
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-003352-67
    A.3Full title of the trial
    A Phase 1/2 single-arm study evaluating the safety and efficacy of eribulin mesilate in combination with irinotecan in children with refractory or recurrent solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 and 2 trial studying how well a combination of eribulin mesilate and irinotecan works in children with different types of cancer that are not responding to treatment or have reappeared following an initial recovery. The aim of the study is to find out how safe and effective the drug combination is in this treating this types of cancer.
    A.4.1Sponsor's protocol code numberE7389-G000-213
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/264/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEisai 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 supportEisai Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Europe 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+440845676 1400
    B.5.5Fax number+440845676 1401
    B.5.6E-mailEUMedInfo@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 Yes
    D.2.1.1.1Trade name Halaven
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHalaven
    D.3.2Product code E7389
    D.3.4Pharmaceutical form Solution for injection
    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 INNERIBULIN MESILATE
    D.3.9.2Current sponsor codeE7389
    D.3.9.4EV Substance CodeSUB31134
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNIRINOTECAN HYDROCHLORIDE
    D.3.9.3Other descriptive nameIninotecan hydrochloride
    D.3.9.4EV Substance CodeSUB02772MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Phase 1: paediatric subjects with relapsed/refractory solid tumors (excluding CNS)
    Phase 2: paediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS)
    E.1.1.1Medical condition in easily understood language
    Different types of cancer that are not responding to treatment or have
    reappeared following an initial recovery
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Phase 1: To determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with weekly and daily irinotecan hydrochloride in paediatric subjects with relapsed/refractory solid tumors (excluding CNS)

    • Phase 2: To assess the objective response rate (ORR) and duration of response (DOR) of eribulin mesilate in combination with irinotecan hydrochloride in paediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS)
    E.2.2Secondary objectives of the trial
    Phase 1:
    • To assess the safety and tolerability of eribulin mesilate in combination with irinotecan hydrochloride in paediatric subjects
    • To determine the optimal schedule of irinotecan hydrochloride when administered with standard schedule (Days 1 and 8) of eribulin mesilate in paediatric subjects

    Phase 2:
    • To assess Progression Free Survival (PFS) of eribulin mesilate in combination with irinotecan hydrochloride in paediatric subjects.
    • To assess the Clinical Benefit Rate (CBR) at 12 weeks of eribulin mesilate in combination with irinotecan hydrochloride in paediatric subjects

    Phase 1&2:
    • To evaluate the pharmacokinetic profile of eribulin, irinotecan and its active metabolite and compare to appropriate historical data
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: ≥12 months to <18 years old at the time of consent. >6 months and <12 months at the times of consent (Phase 1 and Schedule A only) subjects will be enrolled one dose level behind he dose level at which the ≥12 months to <18 years old group are enrolled.
    2. Diagnosis:
    Phase 1: Histologically confirmed solid tumor, excluding CNS tumor, which is relapsed or refractory, and for which there are no currently available therapies.
    Phase 2: Histologically confirmed RMS, NRSTS or EWS which is relapsed or refractory having received at least 1 prior therapy), including primary treatment.
    3. Disease status:
    Phase 1: Subjects must have either measurable or evaluable disease as per RECIST 1.1.
    Phase 2: Subjects must have measurable disease as per RECIST 1.1.
    Measurable disease is defined as meeting the following criteria:
    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 that is serially measurable according to RECIST 1.1 using computed tomography/magnetic resonance imaging (CT/MRI).
    b. Lesions that have had radiotherapy must show subsequent radiographic evidence of increase in size by at least 20% to be deemed a target lesion.
    4. Therapeutic options: Subject’s current disease state must be one for which there is no known curative therapy.
    5. Performance level: Performance score ≥50% Karnofsky (for subjects >16 years of age) or Lansky (for subjects ≤16 years of age).
    6. Subjects must have fully recovered from the acute toxic effects of all prior anticancer treatments prior to study drug administration:
    • Myelosuppressive chemotherapy: Must not have received within 21 days to study drug administration (42 days if prior nitrosourea).
    • Hematopoietic growth factors: Must not have received a long-acting growth factor (eg, Neulasta) within 14 days or a short-acting factor within 7 days. For agents that have known AEs occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor.
    • Targeted therapy (antineoplastic agent eg, tyrosine kinase inhibitor): Must not have received an antineoplastic targeted therapy within 14 days. For agents that have known AEs occurring beyond 14 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor.
    • Immunotherapy: Must not have received immunotherapy, e.g. tumor vaccines, within 42 days.
    • Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody.
    • Radiotherapy (XRT): Must not have received within 14 days prior to study drug administration (small field) or 42 days for craniospinal XRT, or if ≥50% radiation of pelvis.
    • Autologous Stem cell infusion: At least 84 days must have elapsed after stem cell infusion prior to study drug administration.
    • Allogeneic bone marrow transplant, including mini-transplant: No evidence of active Graft vs. Host disease and at least 100 days must have elapsed after transplant or stem cell infusion prior to study drug administration.
    7. Adequate bone marrow function, defined as:
    • Peripheral absolute neutrophil count (ANC) ≥1 × 109/L.
    • Platelet count ≥100 × 109/L (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to study drug administration).
    • Hemoglobin (Hb) at least 8.0 g/dL at baseline (blood transfusions are allowed during the screening period to correct Hb values less than 8.0 g/dL).

    As blood transfusions are permitted to meet the hemoglobin criteria, subjects must not be known to be refractory to red blood cell or platelet transfusions.
    8. Adequate renal function, defined as:
    • A serum creatinine based on age/gender, derived from the Schwartz formula for estimating GFR. Refer to table in protocol.
    • Or serum creatinine clearance or GFR ≥50ml/min/1.73m2, based on a 12 or 24h urine creatinine collection.
    9. Adequate liver function, defined as:
    • Bilirubin (sum of conjugated + unconjugated) ≤1.5 times the ULN for age.
    • Alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN (in the case of liver metastases ≤5 × ULN), unless there are bone metastases, in which case liver-specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
    • Serum albumin ≥2 g/dL.
    10. Informed consent: All subjects and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. Subjects must be willing to comply with all aspects of the protocol.
    E.4Principal exclusion criteria
    1. Pregnancy, breastfeeding, contraception: Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic [β-hCG] (or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
    - Females of childbearing potential* who:
    ◦ Do not agree to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation, ie:
    ◦ Total abstinence (if it is their preferred and usual lifestyle)
    ◦ An intrauterine device (IUD) or intrauterine system (IUS)
    ◦ A contraceptive implant
    ◦ an oral contraceptive**
    OR
    ◦ Do not have a vasectomized partner with confirmed azoospermia.
    *All post pubertal females will be considered to be of childbearing
    potential unless they have early menopause (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
    **Must be on a stable dose of the same oral hormonal contraceptive product for at least 4 weeks before dosing with study drug and for the duration of the study and for 6 months after study drug discontinuation.
    2. Concomitant Medications:
    ◦ Corticosteroids: Subjects receiving corticosteroids who have not been on a stable dose for at least 7 days prior to study drug administration.
    ◦ Anticancer agents: Subjects who are currently receiving other anticancer agents.
    ◦ Anti-GVHD agents post-transplant: Subjects who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant.
    ◦ Strong CYP3A4 inducers/inhibitors, including traditional herbal medicinal products (eg St. John's Wort).
    3. Prior Therapies:
    ◦ Phase 1: Received prior therapy with eribulin mesilate within 6 months prior to study drug administration.
    ◦ Phase 2: Received prior therapies with eribulin mesilate or irinotecan hydrochloride (IH) (for prior IH subjects can be included if there was no tumor progression during IH therapy).
    4. Any malignancy that required treatment (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ), within 2 years prior to study drug administration.
    5. Has hypersensitivity to either study drug or any of the excipients.
    6. Has a known prior history of viral hepatitis (B or C) as demonstrated by positive serology (presence of antigens) or have an uncontrolled infection requiring treatment (*Subjects with a known prior history of hepatitis B or C may be eligible pending agreement with the sponsor).
    7. Has > Grade 1 peripheral sensory neuropathy or > Grade 1 peripheral motor neuropathy graded according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies.
    8. Has cardiac pathology, defined as:
    ◦ Subjects with known congestive heart failure, symptomatic or LV ejection fraction <50% or shortening fraction <27% and subjects with congenital long QT syndrome, bradyarrhythmias, or QTc >480 msec on at least 2 separate ECGs.
    9. Has CNS disease: Subjects with brain or subdural metastases are not eligible unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy (eg, surgery or radiotherapy) and have discontinued the use of corticosteroids for this indication for at least 28 days prior to study drug administration.
    Subjects must be clinically stable. It is not the intention of this protocol to treat subjects with active brain metastases.
    10. Have had or are planning to have the following invasive procedures:
    ◦ Major surgical procedure or significant traumatic injury within 28 days prior to study drug administration.
    ◦ Laparoscopic procedure or open biopsy within 7 days prior to study
    drug administration.
    ◦ Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 2 days prior to study drug administration.
    ◦ Core biopsy, including bone marrow biopsy within 2 days prior to study drug administration.
    ◦ Fine needle aspirate within 3 days prior to study drug administration.
    11. Subjects with known human immunodeficiency virus (HIV); due to lack of available safety data for eribulin therapy in HIV infected patients.
    12. Has any serious concomitant illness that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments including active or severe chronic inflammatory bowel disease or bowel obstruction.
    13. Has received a live-virus vaccination within 30 days of planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted.
    E.5 End points
    E.5.1Primary end point(s)
    • Phase 1: The MTD/RP2D of eribulin mesilate in combination with irinotecan hydrochloride in paediatric subjects with relapsed/refractory extra-cranial solid tumors, excluding CNS tumors. Note: Subjects <12 months will not contribute to the determination of MTD/RP2D and data is for descriptive purposes only.

    • Phase 2: Objective response rate (ORR): defined as the proportion of subjects achieving a best overall response of confirmed partial or complete response, as determined by investigator assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Phase 1: DLTs to establish the MTD are assessed during the first cycle for each subject on each dose level.

    • Phase 2: Tumour assessments are performed every 6 weeks until Week 12 and then the frequency of assessments may decrease to every 9 weeks (or sooner if clinically indicated).
    E.5.2Secondary end point(s)
    Phase 1 & 2 Endpoints:
    • Safety and tolerability: adverse events (AEs), serious adverse events, clinical laboratory values, ECG parameters, vital sign measurements and physical examinations

    Timepoint of evaluation:
    Following provision of informed consent/assent and through out the study until 28 days after the last dose of study drug.

    • The pharmacokinetic profile of eribulin, irinotecan and its active metabolite.

    Timepoint of evaluation:
    Phase 1 (Cycle 1): For subjects ≥12 months and > 10 kg (Irinotecan, its metablite and eribulin will be assayed).
    Cycle 1, Day 1: At the end of the irinotecan infusion (irinotecan is administered first), and at the end of the eribulin infusion, then at 1, 2, 4, 6 and 24 hours post-eribulin infusion. Both irinotecan (and its metabolite, SN-38) and eribulin will be assayed. At 72 and 120 hours post eribulin infusion, eribulin only will be assayed.
    For subjects <12 months as well as those ≥12 months of age and ≤10 kg (subjects under 6 kg will not have PK samples taken (Irinotecan, its metablite and eribulin will be assayed).
    Cycle 1, Day 1: At the end of the irinotecan infusion (Irinotecan is administered first) and then immediately after the end of the eribulin infusion (ie 10 ± 5 minutes from the start of the eribulin infusion).
    Cycle 1, Day 4 or 5: During the collection of the first twice weekly CBC sample.
    Cycle 1, Day 8: Before the eribulin infusion and then immediately after the end of the eribulin infusion (ie 10 ± 5 minutes from the start of the eribulin infusion).

    Phase 2 Endpoints:
    • Progression-free survival (PFS): defined as the time from the first dose date to the date of disease progression as determined by investigator review, or death

    Timepoint of evaluation:
    Progression-free survival, defined as the time from the date of first dose to the date of first documentation of disease progression, or date of death (whichever occurs first).

    • The Clinical Benefit Rate (CBR): defined as the proportion of subjects with best overall response (BOR) of CR, PR or durable SD based on RECIST 1.1 (durable SD >11 weeks)

    Timepoint of evaluation:
    Clinical Benefit Rate, defined as the proportion of subjects with best overall response (BOR) of CR, PR or durable SD based on RECIST 1.1 (durable SD >11 weeks).
    E.5.2.1Timepoint(s) of evaluation of this end point
    As detailed under Secondary endpoint (above). Not possible to detail in full in this field due to limit on number of characters.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Paediatric study
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    France
    Germany
    Greece
    Italy
    Poland
    Spain
    Switzerland
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months3
    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 months3
    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 Yes
    F.1.1Number of subjects for this age range: 111
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 7
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 74
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 111
    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)
    As long as the subject is still receiving clinical benefit and has not experienced intolerable toxicity, he or she can continue to receive study treatment for up to 1 year, from start of study treatment, after which any continued treatment would need to be discussed with the Sponsor.
    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 Decision2017-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
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