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    Summary
    EudraCT Number:2017-000742-21
    Sponsor's Protocol Code Number:2017/2527
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-31
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-000742-21
    A.3Full title of the trial
    Efficacy of a selective MEK (trametinib) and BRAFV600E (dabrafenib) inhibitors associated with radioactive iodine (RAI) for the treatment of refractory metastatic differentiated thyroid cancer with RAS or BRAFV600E mutation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of trametinib and dabrafenib associated with radioactive iodine for the treatment of refractory metastatic differentiated thyroid cancer
    A.3.2Name or abbreviated title of the trial where available
    MERAIODE
    A.4.1Sponsor's protocol code number2017/2527
    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 SponsorGustave Roussy
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportGenzyme
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGustave Roussy
    B.5.2Functional name of contact pointCRA
    B.5.3 Address:
    B.5.3.1Street Address114 rue Edouard Vaillant
    B.5.3.2Town/ cityVillejuif
    B.5.3.3Post code94800
    B.5.3.4CountryFrance
    B.5.6E-maildune.lemettre@gustaveroussy.fr
    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 Tafinlar
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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.3.1Product nameDabrafenib
    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 INNDabrafenib
    D.3.9.1CAS number 1195765-45-7
    D.3.9.3Other descriptive nameDABRAFENIB
    D.3.9.4EV Substance CodeSUB45696
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDabrafenib
    D.3.9.1CAS number 1195765-45-7
    D.3.9.3Other descriptive nameDABRAFENIB
    D.3.9.4EV Substance CodeSUB45696
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Mekinist
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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.3.1Product nameTrametinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNTRAMETINIB
    D.3.9.2Current sponsor codeTrametinib
    D.3.9.4EV Substance CodeSUB119776
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRAMETINIB
    D.3.9.2Current sponsor codeTrametinib
    D.3.9.4EV Substance CodeSUB119776
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 RoleComparator
    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 Thyrogen
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme
    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 namethyrotropin alfa
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHYROTROPIN ALFA
    D.3.9.1CAS number 194100-83-9
    D.3.9.2Current sponsor codeThyrotropin Alfa
    D.3.9.4EV Substance CodeSUB12610MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 Yes
    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
    Metastatic Radioactive Iodine Refractory Thyroid Cancer Patients with RAS or BRAF mutation
    E.1.1.1Medical condition in easily understood language
    Thyroid Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016935
    E.1.2Term Follicular thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10066474
    E.1.2Term Thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033701
    E.1.2Term Papillary thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the objective response rate according to RECIST criteria in thyroid cancer patients with metastatic radioactive iodine (RAI) refractory disease, 6 months after a treatment combining in each arm of the phase II trial (patients with RAS mutation or patients with BRAFV600E mutation):
    - Arm A: 6 weeks of trametinib followed by RAI treatment (5.5 GBq following rhTSH) in patients with RAS mutation
    - Arm B: 6 weeks of trametinib plus dabrafenib followed by RAI treatment (5.5 GBq following rhTSH) in patients with BRAFV600E mutation
    E.2.2Secondary objectives of the trial
    -To evaluate the progression free-survival after the first dose of treatment
    -To evaluate the duration of response after the first dose of treatment
    -To evaluate the best overall response after the first dose of treatment
    -To evaluate the best overall response after the first dose of the second course of treatment
    -To evaluate the disease control rate at 1, 3, 6, +/- 12 and 18 months after the first dose of the first course of treatment
    -To evaluate the disease control rate at 1, 3, 6, 12 and 18 months after the first dose of the second course of treatment
    -To evaluate the objective Response Rate at 1, 3, 6, 12, 18 months after the first dose of drug
    -To evaluate the fluorodesoxyglucose metabolic response 6 months after initiation of treatment
    -To describe the changes in serum thyroglobulin levels
    -To assess the safety and tolerability of treatment
    -To describe the evolution of the patients quality of life
    -To perform a translational research ancillary study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with thyroid carcinoma of follicular origin (papillary, follicular or poorly differentiated and their respective variants)
    - Known positive RAS (NRAS or KRAS or HRAS) or BRAFV600E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples sent for central testing or on a biopsy sample sent for central testing).
    - Radioiodine-refractory disease defined by at least one of the following item:
     Distant metastasis without radioiodine uptake on a post-therapeutic radioactive scan
     Distant metastasis disclosing RECIST progression within 12 months after a RAI treatment
    - Measurable disease with at least one lesion  1.0 cm in the longest diameter for a non-lymph node or  1.5 cm in the short axis for a lymph node, measured with spiral computed tomography (CT) without iv contrast injection or magnetic resonance imaging (MRI) according to RECIST 1.1
    - Progressive disease according to RECIST 1.1 criteria within 18 months prior initiation of treatment
    - Absence of metastatic lesion > 30mm
    - Previous cumulated activity of radioactive iodine ≤ 300 mCi (11.1GBq)
    - Patients may have received prior treatment with either 1 line of Tyrosine Kinase Inhibitor or 1 line of immunotherapy (excluding anti BRAF or anti MEK treatment such as sorafenib, dabrafenib, trametinib and selumitinib) but should be off treatment within 28 days prior to treatment start
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    - Blood pressure (BP) ≤ 140/90 mm Hg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1
    - Creatinine clearance ≥50 mL/min according to the Cockcroft and Gault formula
    - Adequate bone marrow function with :
     Absolute neutrophil count (ANC) ≥1.5 x 109/L
     Hemoglobin ≥9.0 g/dL
     Platelet count ≥100 x 109/L
     Normal blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5
    - Adequate liver function with:
     Bilirubin ≤1.5 × upper limit of normal (ULN) except for unconjugated hyperbilirubinemia or Gilbert’s syndrome,
     Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver metastases).
    - Males or females age ≥ 18 years at the time of informed consent
    - Women of childbearing potential must have a negative urine or serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment. Sexually active women of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 12 months after the last study treatment administration. Sexually active males patients must agree to use condom during the study and for at least 12 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
    - In case of previous external beam radiation, all radiation therapy-related toxicities must have resolved to < Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE v 4.0), except alopecia and infertility.
    - Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
    - Patient affiliated to a social security regimen or beneficiary of the same
    E.4Principal exclusion criteria
    - Undifferentiated or Medullary (MTC) carcinoma of the thyroid
    - Brain metastases (including asymptomatic brain metastases)
    - Major surgery within 4 weeks prior to the first dose of drug
    - Subjects having > 1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥ 1 g/24 h will be ineligible.
    - Need for locoregional treatment such as surgery, external beam radiation or thermoablation at inclusion
    - Prior RAI therapy < 6 months prior initiation of treatment
    - External beam radiation < 4 weeks prior initiation of treatment
    - Iodine contamination defined by a urine ioduria ≥ 50 µg/dl
    - Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of the drugs
    - History of congestive heart failure greater or equal to than New York Heart association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of drug, or cardiac arrhythmia associated with significant cardiovascular impairment and uncontrolled hypertension
    - Electrocardiogram (ECG) with QT interval (QTc) interval ≥480 msec
    - Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 2 months prior to the first dose of drug and any other active bleeding, coagulopathy or pathologic condition that would confer a high risk of bleeding.
    - Active infection requiring systemic therapy
    - Active malignancy (except for DTC, or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months
    - Any history of or concomitant medical condition that, in the opinion of the investigator, would compromise subject’s ability to safely complete the protocol
    - Females who are pregnant or breastfeeding
    - Patients with an injection of radio-contrast agent within 8 weeks prior enrolment
    - Previous history of retinal vein occlusion
    - Previous history of central serous retinopathy
    - Known hypersensitivity to the study drugs or to any of the excipients
    E.5 End points
    E.5.1Primary end point(s)
    The Objective Response Rate: the proportion of patients with a best overall response of Complete Response (CR) or a Partial Response (PR) evaluated 6 months after the first dose of trametinib or trametinib and dabrafenib followed par RAI treatment, in each arm (RAS or BRAFV600E mutation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    - The best overall response (CR+PR) after the first dose of trametinib or trametinib and dabrafenib,
    - The objective response rate at 1, 3, 6, +/- 12 and 18 months after the first dose of the first course of trametinib or trametinib and dabrafenib.
    - The objective response rate at 12, 18 months after the first dose of the first course of trametinib or trametinib and dabrafenib for patients not undergoing a second course of treatment
    - The objective response rate at 1, 3, 6, 12 and 18 months after the first dose of the second administration of trametinib or trametinib and dabrafenib (only given in patients with PR occurring after the first course of treatment)
    - The Progression free-survival (PFS), defined as the time from the first dose of trametinib or trametinib and dabrafenib to the date of event defined as the first documented progression or death due to any cause. Patient alive without progression will be censured at last follow-up visit.
    - The Duration of response (DOR) applies only to patients whose best overall response is CR or PR. It is the time from the first documented response (CR or PR) to the first documented disease progression or death due to any cause.
    - The Disease control rate (CR+PR+SD) is the proportion of patients with a best overall response of Complete Response, Partial Response or Stable Disease (SD) at 1, 3, 6, +/- 12 and 18 months after the first dose of trametinib or trametinib and dabrafenib.
    - The Objective Response Rate at 1, 3, 6, 12, 18 months after the start of drug according to i) the intensity of FDG uptake before treatment ii) quantitative changes in RAI uptake evaluated on 131I diagnostic WBS iii) plasmatic residual concentration of trametinib+/-dabrafenib
    - The FDG metabolic response 6 months after treatment according to PERCIST criteria
    - The changes in serum Tg levels is the proportion of changes >50% in Tg level measured at 1, 3, 6 +/- 12 and 18 months after the first dose of the first course of trametinib or trametinib and dabrafenib and the changes in serum Tg levels is the proportion of changes >50% in Tg level measured at 1, 3, 6, 12 and 18 months after the first dose of the second course of trametinib or trametinib and dabrafenib
    - Safety and tolerability of trametinib in RAS mutated patients and of trametinib and dabrafenib in BRAFV600E mutated patients, alone and then in combination with 5.5 GBq of 131I will be evaluated with adverse events (AE) experienced throughout the study and assessed according the NCI-CTC AE version 4.0
    - Quality of life will be evaluated with EORTC Quality of Life Questionnaire C30 (QLQ-C30) at baseline, d14, d28, d42, 3 and 6 months
    - The Objective Response Rate at 3, 6, 12, 18 months after the start of drug according to i) the intensity of FDG uptake before treatment ii) quantitative changes in RAI uptake evaluated on 131I diagnostic WBS
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 1, 3, 6, +/- 12 and 18 months after the first dose of the first course of trametinib or trametinib and dabrafenib.

    At 1, 3, 6, 12 and 18 months after the first dose of the second administration of trametinib or trametinib and dabrafenib (only given in patients with PR occurring after the first course of treatment)
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state87
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 87
    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 Decision2017-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
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