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    Summary
    EudraCT Number:2016-003801-32
    Sponsor's Protocol Code Number:MEDI4736-MM-005
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2017-01-26
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-003801-32
    A.3Full title of the trial
    Multicenter, Single-arm, Phase 2 Study to Determine the Efficacy for the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) who have Progressed on DARA While on a DARA-containing Regimen as the Most Recent Multiple Myeloma Therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the effectiveness for the combination of durvalumab and daratumumab (D2) to treat relapsed and refractory multiple myeloma in subjects whose multiple myeloma has worsened while on a daratumumab therapy as their last multiple myeloma treatment.
    A.3.2Name or abbreviated title of the trial where available
    FUSION MM-005
    A.4.1Sponsor's protocol code numberMEDI4736-MM-005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03000452
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1191-1405
    A.5.4Other Identifiers
    Name:IND numberNumber:127058
    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 SponsorCelgene International II Sàrl
    B.1.3.4CountrySwitzerland
    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 supportCelgene International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park
    B.5.3.3Post codeKS 66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1888260 1599
    B.5.5Fax number+1913266 0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNDURVALUMAB
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanised monoclonal antibody
    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 DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab
    D.3.2Product code JNJ-54767414
    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 INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414
    D.3.9.4EV Substance CodeSUB175772
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanised monoclonal antibody
    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
    Relapsed and Refractory Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Cancer of the bone marrow that has recurred or no longer responds to
    current treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    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
    The primary objective of the study is to determine the efficacy of daratumumab (DARA) plus durvalumab (DURVA) in subjects with relapsed and refractory multiple myeloma (RRMM) who have progressed on a current treatment regimen containing DARA.
    E.2.2Secondary objectives of the trial
    Determine the safety of DARA plus DURVA in subjects with RRMM who have progressed while on a current treatment regimen containing DARA.

    Evaluate additional measures of efficacy of DARA plus DURVA in subjects with RRMM who have progressed on a current treatment regimen containing DARA.

    Evaluate the pharmacokinetics (PK) of DARA plus DURVA in subjects with RRMM who have progressed on a current treatment regimen containing DARA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject received at least 3 prior anti-myeloma regimens including a PI and an immunomodulatory agent or is double-refractory to a PI and an immunomodulatory agent.
    • Induction, bone marrow transplant with or without maintenance therapy is considered one regimen.
    • Refractory is defined as disease that is nonresponsive on therapy, or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy.
    • For subjects who received more than 1 regimen containing a PI their disease must be refractory to the most recent PI containing regimen.
    • For subjects who received more than 1 regimen containing a immunomodulatory agent their disease must be refractory to the most recent immunomodulatory agent containing regimen.
    2. All subjects must have failed DARA either as a single agent or in combination on last MM therapy. Failure is defined as PD on DARA either as a single agent or in combination.
    3. Subject has measurable disease defined as:
    a. M-protein (serum protein electrophoresis (sPEP) or urine protein electrophoresis (uPEP): sPEP ≥ 0.5 g/dL or uPEP ≥ 200 mg/24 hours) and/or
    b. Light chain MM without measurable disease in the serum or the urine: serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
    4. Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
    5. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 2 or less.
    6. Subject’s toxicities resulting from previous therapy (including peripheral neuropathy) have resolved or stabilized to ≤ Grade 1.
    7. Subject is at least 18 years of age at the time of signing the informed consent form (ICF).
    8. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
    9. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
    10. Females of childbearing potential (FCBP) must:
    a. Have 2 negative pregnancy tests as verified by the investigator prior to starting study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
    i. Negative serum pregnancy test at screening
    ii. Negative serum or urine pregnancy test (investigator’s discretion) within 72 hours prior to starting study treatment (Cycle 1, Day 1), and before beginning each subsequent cycle of treatment, and after end of study treatment.
    Note: Pregnancy testing does not need to be repeated prior to Cycle 1 if the serum pregnancy test for screening was performed within 72 hours of the first dose of study treatment.
    b. Either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption (eg, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; true abstinence; or vasectomized partner), 28 days prior to starting study treatment, during the study therapy (including dose interruptions), and for at least 90 days after discontinuation of study treatment.
    c. Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of DARA or DURVA, whichever is later.
    d. Refrain from egg cell donation for at least 90 days after the final dose of DURVA or DARA, whichever is later.
    11. Male subjects must:
    a. Either practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 90 days following study treatment discontinuation, even if he has undergone a successful vasectomy.
    b. Refrain from sperm donation for at least 90 days after the final dose of DURVA or DARA, whichever is later.
    E.4Principal exclusion criteria
    1. Subject has had prior exposure to anti-CTLA-4, anti-PD-1, anti-PD-L1 mAbs, or cancer vaccines
    2. Subject has received ASCT within 12 weeks before the date of randomization.
    3. History of organ or allogeneic stem cell transplantation
    4. Subject received any of the following within the last 14 days of initiating study treatment:
    a. Plasmapheresis
    b. Major surgery
    c. Radiation therapy other than local therapy for myeloma associated bone lesions
    d. Use of any systemic anti-myeloma drug therapy (except for DARA either alone or in combination with other agents given with it)
    5. Subject received prior treatment with a monoclonal antibody within 5 half-lives of initiating study treatment, other than DARA.
    6. Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment.
    7. Subject has any of the following laboratory abnormalities:
    a. ANC < 1,000/µL
    b. Platelet count: < 75,000/µL (it is not permissible to transfuse a subject to reach this level)
    c. Hemoglobin < 8 g/dL (< 4.9 mmol/L)(it is not permissible to transfuse a subject to reach this level)
    d. Creatinine clearance (CrCl) < 45 mL/min (calculated using the Cockcroft-Gault formula or directly calculated from the 24-hour urine collection method)
    e. Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
    f. AST or ALT > 2.5 × ULN
    g. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome
    8. Subject has clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS MM
    9. Subject has known COPD with a FEV1 50% of predicted normal. Note that forced expiratory testing (FEV1)is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is < 50% of predicted normal.
    10. Subject has known moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.
    11. Subject has plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis
    12. Subject has nonsecretory MM
    13. Subject has known allergy or hypersensitivity to study drug formulations
    14. Subject has active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
    a. Subjects with vitiligo or alopecia.
    b. Subjects with hypothyroidism (eg, following Hashimoto’s disease) stable on hormone replacement.
    c. Psoriasis not requiring systemic treatment.
    15. Subject has history of primary immunodeficiency
    16. Subject is positive for HIV-1, chronic or active hepatitis B or active hepatitis A or C.
    17. Subject has received live, attenuated vaccine within 30 days prior to the first dose of DURVA.
    18. Subject is currently using or has used immunosuppressive medication within 14 days prior to the first study dose of study treatment. The following are exceptions to this criterion:
    a. Intranasal, topical, inhaled, or local steroid injections (eg, intra-articular injection).
    b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent.
    c. Steroids as premedication for hypersensitivity reactions (eg, infusion-related reactions, computed tomography [CT] scan premedication).
    19. Subject has any one of the following:
    a. Clinically significant abnormal ECG finding at screening
    b. Congestive heart failure (NYHA Class III or IV)
    c. Myocardial infarction within 12 months prior to starting study treatment
    d. Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
    20. Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following noninvasive malignancies:
    a. Basal cell carcinoma of the skin
    b. Squamous cell carcinoma of the skin
    c. Carcinoma in situ of the cervix
    d. Carcinoma in situ of the breast
    e. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) or prostate cancer that is curative
    21. Subject is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study.
    22. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    23. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
    24. Subject has any condition that confounds the ability to interpret data from the study
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) - Tumor response (partial response [PR] or better), and the rate of progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR will be assessed throughout the study.
    E.5.2Secondary end point(s)
    Safety - Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment

    Time-to-response (TTR) - Time from treatment initiation to the first documentation of response (PR or greater)

    Duration of response (DOR) - Time from the first documentation of response (PR or greater) to the first documentation of PD or death, whichever is earlier, based on the investigator assessments according to the IMWG Uniform Response Criteria

    Progression-free survival (PFS) - Time from treatment initiation to the first documentation of PD or death from any cause during study, whichever occurs earlier

    Overall survival (OS) - Time from treatment initiation to death due to any cause

    Pharmacokinetic (PK) parameters - Typical serum/plasma PK parameters for DURVA and DARA, such as maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), terminal elimination half-life (t1/2), clearance (CL/F), and volume of distribution (Vz/F)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety, TTR, DOR, PFS and OS will be assessed throughout the study.

    DURVA PK sample time points Part 1 Stage 1:
    • C1D2: pre dose (-30 to -5 mins prior to dose), end of infusion (EOI) (+5 mins),
    • C1D8: 144 hrs post C1D2 dose (± 1 hr)
    • C1D15: 312 hrs post C1D2 dose (± 1 hr),
    • C1D22: 480 hours post C1D2 dose (± 1 hr).
    • Predose on C2D1, C4D1, C6D1, C10D1, and C14D1.

    DARA PK time points Part 1 Stage 1:
    · C1D1: predose (-30 to -5 mins prior to dose), and EOI (+5 mins)
    · C1D8: predose (-30 to -5 mins prior to dose), and EOI (+5 mins)
    · C1D15: predose (-30 to -5 mins prior to dose), and EOI (+5 mins)
    · C1D22: predose (-30 to -5 mins prior to dose), and EOI (+5 mins)
    · EOT
    · 28 days after EOT,
    · 90 days after last DARA or DURVA 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Austria
    Canada
    Germany
    Greece
    Italy
    Netherlands
    Spain
    Sweden
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre specified in the protocol, whichever is the later date.
    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 months6
    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 months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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 - patients will revert to standard of care as per treating physician
    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 Decision2017-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-01
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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