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    Summary
    EudraCT Number:2017-001554-33
    Sponsor's Protocol Code Number:BGB-290-104
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-001554-33
    A.3Full title of the trial
    A Phase 1b/2 study to assess the safety, tolerability and efficacy of BGB-290 in combination with radiation therapy and/or temozolomide in subjects with first-line or recurrent/refractory glioblastoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A safety and efficacy study of the drug BGB-290 in combination with radiation therapy and/or temozolomide (TMZ) in patients with brain cancer.
    A.4.1Sponsor's protocol code numberBGB-290-104
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03150862
    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 SponsorBeiGene USA, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBeiGene USA, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene USA, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Email
    B.5.3 Address:
    B.5.3.1Street Address2929 Campus Drive
    B.5.3.2Town/ citySan Mateo
    B.5.3.3Post codeCA 94403
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@beigene.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 nameBGB-290
    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 INNpamiparib
    D.3.9.1CAS number 1446261-44-4
    D.3.9.3Other descriptive nameBGB-290
    D.3.9.4EV Substance CodeSUB188812
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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.2.1.1.1Trade name Temozolomide Accord 20 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    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.3.4Pharmaceutical form Capsule
    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 INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 3
    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 Temozolomide Accord 100 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited
    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.3.4Pharmaceutical form Capsule
    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 INNtemozolomide
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.9.4EV Substance CodeSUB10889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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: 4
    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 nameBGB-290
    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 INNpamiparib
    D.3.9.3Other descriptive nameBGB-290
    D.3.9.4EV Substance CodeSUB188812
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 Yes
    D.3.11.13.1Other medicinal product typeBGB-290 is a potent and selective inhibitor of PARP1 and PARP2.
    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
    glioblastoma
    E.1.1.1Medical condition in easily understood language
    brain cancer
    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:

    1) Arm A:
    • To assess safety and tolerability of BGB-290 combined with RT
    • To identify dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for BGB-290 combined with RT
    • To select the recommended Phase 2 schedule for full-dose BGB 290 combined with RT

    2) Arm B:
    • To assess safety and tolerability of BGB-290 combined with RT and TMZ
    • To identify DLTs and determine the MTD or MAD for TMZ combined with RT and the MTD/MAD for BGB-290 of Arm A
    • To select the RP2D for TMZ combined with RT and the MTD/MAD for BGB-290 of Arm A

    3) Arm C:
    • To assess safety and tolerability of BGB-290 combined with TMZ
    • To identify DLTs and determine the MTD or MAD for TMZ combined with full-dose BGB-290
    • To select the RP2D for TMZ combined with full-dose BGB 290

    PHASE 2:

    To assess the efficacy of BGB-290 combined with:
    1) RT (Arm A)
    2) RT and TMZ (Arm B)
    3) TMZ (Arm C)
    E.2.2Secondary objectives of the trial
    Phase 1b, all Arms
    • To characterize the PK of BGB-290 in combination with RT and/or TMZ
    • To make a preliminary assessment of BGB-290 efficacy in combination with RT and/or TMZ

    Phase 2, all Arms
    • To assess safety and tolerability of BGB-290 in combination with RT and/or TMZ
    • To characterize the PK of BGB-290 in combination with RT and/or TMZ
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ALL PATIENTS
    1 Age ≥ 18 years old.
    2 Confirmed diagnosis of glioblastoma (WHO Grade IV).
    3 Ability to undergo serial MRIs.
    4 ECOG status ≤ 1.
    5 Adequate bone marrow function.
    6 Adequate renal and hepatic function.
    7 Ability to swallow whole capsules.
    Subjects in Arms A and B (not Arm C) must also meet inclusion criteria:
    8 No previous treatment for GB except surgery.
    9 Able to start radiation therapy ≤ 49 days after surgery but ≥ 14 days
    after a biopsy or ≥28 days after an open biopsy or craniotomy with
    adequate wound healing.
    10 Documented unmethylated MGMT promoter status.
    Subjects in Arm C ESCALATION only must also meet inclusion criteria:
    11 Documentation of MGMT promoter status
     It is preferable to determine MGMT status by MS-PCR. Other
    acceptable platforms include pyrosequencing methodologies and MSHRM
    assays with comparable sensitivity, applied to archival or fresh
    tumor tissue.
    12 No prior systemic chemotherapy other than TMZ for GB and nd no
    prior anti-angiogenic therapy
    13 Histologically confirmed secondary glioblastoma
    14 Progressive disease > 2 months after completion of first line therapy.
    15 Disease that is evaluable or measurable by mRANO
    Subjects in Arm C EXPANSION only must also meet inclusion criteria:
    16 Histologically confirmed de novo (primary) glioblastoma with
    unequivocal first
    progressive disease (PD) after RT with concurrent/adjuvant TMZ
    chemotherapy as defined
    by one or more of the following:
     PD ≥ 3 months after the end of radiotherapy
     PD that is clearly outside the radiation field
     PD that has been unequivocally proven by surgery/biopsy
    17 Disease that is measurable as defined by RANO criteria
    18 Documentation of MGMT promoter status.
    For full list of inclusion criteria refer to the study protocol.
    E.4Principal exclusion criteria
    ALL PATIENTS:
    1. Chemotherapy, biologic therapy, immunotherapy, or investigational
    agent ≤ 21 days (or ≤ 5 half-lives, whichever is shorter) prior to Day 1
    2. Unresolved acute effects of any prior therapy of Grade ≥ 2, except for
    AEs not constituting a safety
    risk by investigator judgement
    3. Major surgical procedure, open biopsy, or significant traumatic injury
    ≤ 28 days prior to Day 1, or anticipation of need for major surgical
    procedure during the course of the study.
    4. Other diagnosis of malignancy
     - Except for surgically excised non-melanoma skin cancer, adequately
    treated carcinoma in situ of the cervix, localized prostate cancer treated
    with curative intent, adequately treated low-stage bladder cancer, ductal
    carcinoma in situ treated surgically with curative intent, or a malignancy
    diagnosed >2 years ago with no current evidence of disease and no
    therapy ≤ 2 years prior to Day 1
    5. Active infection requiring systemic treatment
    6. Active cardiac disease, inflammatory gastrointestinal disease,
    bleeding disorder (for details see protocol)
    7. Anticoagulation with heparin, warfarin, or other anticoagulants (for
    details see protocol)
    8. Use ≤ 10 days (or ≤ 5 half-lives, whichever is shorter) prior to Day 1
    or anticipated need for food or
    drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A
    inducers including known enzyme inducing anti-epileptic drugs
    FOR PATIENTS IN Arm B and C (NOT applicable to Arm A)
    9. Known hypersensitivity to any temozolomide component or to
    dacarbazine (DTIC)
    10. Have hereditary problems of galactose intolerance, the Lapp lactase
    deficiency, or
    glucose-galactose malabsorption
    For full list of exclusion criteria see protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b, all Arms
    1) Incidence and nature of DLTs
    2) Incidence, nature, and severity of AEs, graded according to the NCI-CTCAE, v4.03
    3) Number of cycles (Arm C only) and the dose intensity of each component of the treatment regimens, and changes in vital signs and clinical laboratory test results during and following study treatment

    Phase 2, Arm A and B
    4) Modified disease control rate (DCR) as assessed using the modified Response Assessment in Neuro-Oncology (mRANO), version 1.1
    Phase 2, Arm C
    5) Objective response rate (ORR) as assessed using mRANO
    E.5.1.1Timepoint(s) of evaluation of this end point
    1,2,3: During weekly visits
    4,5: within 14 days prior to Day 1 and then approximately 4 weeks after completion of RT as part of the EOT visit. Subjects without progressive disease at the EOT visit every 8 weeks (± 7 days) during the Follow-up Phase.
    E.5.2Secondary end point(s)
    Phase 1b, all Arms
    1) PK parameter for pamiparib of steady-state Ctrough
    2) Modified DCR (Arms A and B), DCR (Arm C), ORR and clinical benefit rate (CBR)
    3) Time-to-event endpoints: e.g., duration of response (DOR), progression-free survival (PFS) and overall survival (OS)

    Phase 2, Arm A and B
    4) ORR and CBR as assessed using RANO criteria
    5) Time-to-event endpoints: e.g., DOR, PFS and OS
    6) Incidence, nature, and severity of AEs, graded according to NCI-CTCAE, v4.03
    7) The dose intensity of each component of the treatment regimens, and changes in vital signs and clinical laboratory test results during and following study treatment
    8) PK parameter for pamiparib

    Phase 2, Arm C
    9) DCR and CBR as assessed using RANO criteria
    10) Time-to-event endpoints: e.g., DOR, PFS and OS
    11) Incidence, nature, and severity of AEs, graded according to NCI-CTCAE, v4.03
    12) Number of cycles and the dose intensity of each component of the treatment regimens, and changes in vital signs and clinical laboratory test results during and following study treatment
    13) PK parameter for pamiparib
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,8, 13: Day 1, 15, EOT (Arm A), Day 1, 15 (Arm B, C)
    2,3,4,5,9,10: Within 14 days prior to Day 1 and EOT. Subjects without progressive disease at the EOT visit must then be followed with MRIs every 8 weeks (± 7 days) during the Follow-up Phase.
    6,7,11,12: weekly during study visits
    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 Yes
    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
    dose escalation
    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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    European Union
    Switzerland
    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 years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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)
    At this time, there are no plans to provide further treatment after patients ended their participation in the trial.
    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 Decision2017-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-24
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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