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    Summary
    EudraCT Number:2016-001599-31
    Sponsor's Protocol Code Number:N16INM
    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:2016-08-22
    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 number2016-001599-31
    A.3Full title of the trial
    Ipilimumab and Nivolumab in the Treatment of malignant Pleural Mesothelioma: a Phase II study
    Ipilimumab en Nivolumab bij de behandeling van maligne pleuraal mesothelioom: een fase II studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ipilimumab and Nivolumab in patients with malignant Pleural Mesothelioma: INITIATE
    Ipilimumab en Nivolumab bij patienten met een maligne pleuraal mesothelioom: INITIATE
    A.4.1Sponsor's protocol code numberN16INM
    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 SponsorStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
    B.1.3.4CountryNetherlands
    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 supportStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
    B.5.2Functional name of contact pointProf. Dr. P. Baas
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205129098
    B.5.5Fax number0031205122572
    B.5.6E-mailp.baas@nki.nl
    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 nameNivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection/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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameBMS936558
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIpilimumab
    D.3.4Pharmaceutical form 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 INNIPILIMUMAB
    D.3.9.3Other descriptive nameMDX101
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Malignant pleural mesothelioma
    Maligne pleuraal mesothelioom
    E.1.1.1Medical condition in easily understood language
    Maligne pleural mesothelioma
    Kwaadaardig longvlieskanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10027408
    E.1.2Term Mesothelioma malignant advanced
    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 the disease control rate (DCR) at 12 weeks of the combination treatment of Nivolumab and Ipilimumab in patients with progressive MPM.
    De primaire doelstelling van de studie is het bepalen van de DCR (ziekteaktiviteit) bij 12 weken combinatie behandeling met Nivolumab en Ipilimumab bij patienten met progressieve MPM.
    E.2.2Secondary objectives of the trial
    - to determine the safety profile of the combination treatment of Nivolumab plus Ipilimumab in patients with advanced MPM
    - to determine DCR at 6 months, PFS and OS in the study population
    - to determine objective response rate (ORR) as defined by modified RECIST criteria
    - to determine the immunological changes of tumors before and after 6 weeks of treatment. This research will include PD-L1 status and other possible biomarkers.
    - Het bepalen van het veiligheidsprofiel van de combinatie behandeling van Nivolumab met Ipilimumab bij patienten met gevorderd MPM
    - Het bepalen van de DCR bij 6 maanden, PFS en OS in de studiepopulatie
    - Het bepalen van de objectieve respons rate (ORR) zoals gedefinieerd in de gemodifieerde RECIST criteria
    - Het bepalen van de immunologische veranderingen in de tumoren voor en na 6 weken behandeling. Dit onderzoek zal de PD-L1 status en andere mogelijke biomarkers bepalen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed informed consent form
    • Age ≥ 18 years
    • WHO-ECOG performance status 0 or 1
    • Able to comply with the study protocol, in the investigator’s judgment
    • Patients with histologically confirmed diagnosis of the recurrence of MPM. Any pleural MPM subtype is permitted for inclusion in the study.
    • Progressive disease after at least one prior systemic treatment with a platinum-based doublet (both cisplatin and carboplatin are allowed) for unresectable MPM. All prior cytotoxic toxicities must have resolved to grade ≤ 1 prior to registration
    • Measurable disease on CT scan, according to modified RECIST Criteria for Mesothelioma (Byrne MJ, 2004)
    • Life expectancy ≥ 12 weeks
    • Adequate hematologic and organ function, defined by the following laboratory results, obtained within 14 days prior to the first study treatment:
    - Absolute neutrophil count (ANC) ≥ 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
    - WBC count ≥ 3000 cells/µL
    - Lymphocyte count ≥ 250 cells/µL
    - Platelet count ≥ 100.000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
    - Hemoglobin ≥ 5.6 mmol/L
    - Serum albumin ≥ 25 gr/L
    - AST, ALT and alkaline phosphatase ≤ 2.5 x ULN, with the following exceptions: patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN
    - Serum bilirubin ≤ 1.5 x ULN
    Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled
    - INR and aPTT ≤ 1.5 x ULN
    Patients receiving therapeutic anticoagulation should be on a stable dose
    - Creatinine clearance ≥ 45 mL/min
    Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration or Modification of Diet in Renal Disease formulae may be used; 24-hour urine collection is not required
    • Women who are not postmenopausal (≥ 12 months of non-therapy−induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus) and men with partners of childbearing potential, must agree to use adequate contraception (double barrier birth control) for the whole duration of study treatment and for 3 months after the last dose of therapy
    • Women of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior the first dose of treatment
    • Getekend informed consent formulier
    • Leeftijd ≥ 18 jaar
    • WHO-ECOG performance status 0 of 1
    • Kunnen voldoen aan het studie protocol, als de uitspraak van de onderzoeker
    • Patiënten met histologisch bewezen recidiverend maligne mesothelioom. Elk subtype van een pleurale maligne mesothelioom wordt toegestaan bij includering in de studie.
    • Progressieve ziekte na minstens 1 eerdere systemische behandeling met een platinum-gebaseerd doublet (zowel cisplatin als carboplatin zijn toegestaan) voor niet-resecteerbaar MPM. Alle eerdere cytotoxische toxiciteiten moeten ≤ graad 1 zijn voor registratie.
    • Meetbare ziekte op CT scan, volgens de gemodificeerde RECIST criteria voor mesothelioom
    • Levensverwachting ≥ 12 weken
    • Adequaat hematologisch en orgaan functioneren, gedefinieerd door de volgende laboratorium resultaten, die binnen 14 dagen voor de eerste onderzoeksbehandeling verkregen zijn
    - Absolute neutrofielen (ANC) ≥ 1500 cells/µL (zonder GCSF ondersteuning binnen 2 weken voor de eerste dag van de eerste kuur)
    - WBC ≥ 3000 cells/µL
    - Lymfocyten ≥ 250 cells/µL
    - Bloedplaatjes ≥ 100.000/µL (zonder transfusie binnen 2 weken voor kuur 1, dag 1)
    - Hemoglobine ≥ 5.6 mmol/L
    - Serum albumin ≥ 25 gr/L
    - AST, ALT en alkalische fosfatase ≤ 2.5 x ULN, met de volgende uitzonderingen: patiënten met gedocumenteerde lever of botmetastasen: alkalische fosfatase ≤ 5 x ULN
    - Serum bilirubine ≤ 1.5 x ULN
    Patiënten die bekend zijn met de Gilbert ziekte en die een serum bilirubine level ≤ 3 x ULN, Mogen geincludeerd worden.
    - INR en aPTT ≤ 1.5 x ULN
    Patiënten die therapeutische anticoagulatie krijgen, moeten op een stabiele dosis zijn
    - Kreatinine klaring ≥ 45 mL/min
    Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration of Modification of Diet in Renal Disease formulae mogen gebruikt worden: 24-uurs urine verzameling is niet vereist
    • Vrouwen die niet postmenopausal zijn (≥ 12 maanden niet-therapie-geinduceerd amenorrhea) of chirurgisch gesteriliseerd (afwezigheid van eierstokken en/of baarmoeder) en mannen met partners in de vruchtbare leeftijd moeten gebruik maken van adequate contraceptive (dubbele barriere geboorte controle) gedurende de onderzoeksbehandeling en tot en met 3 maanden na de laatste dosis van het onderzoeksmiddel
    • Vrouwen in de vruchtbare leeftijd moeten een negatieve serum of urine zwangerschapstest binnen 48 uur voor de eerste dosis van de behandeling hebben
    E.4Principal exclusion criteria
    • Medical or psychological impediment to comply with the protocol
    • Patients with only peritoneal MPM
    • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for at least five years
    • Concomitant participation in another clinical trial (by the investigator’s judgement)
    • Uncontrolled pleural/peritoneal effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    • Uncontrolled tumor-related pain
    Patients requiring pain medication must be on a stable regimen at study entry.
    Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment.
    • Previous treatment with any checkpoint inhibitor
    • Pregnant or lactating women
    • Patients with brain metastases
    • History of or active autoimmune disease (e.g. pneumonitis; rheumatoid arthritis; severe form of psoriasis; uncontrolled type I diabetes or hypothyroidism)
    • History of idiopathic pulmonary fibrosis (including pneumonitis) or unresolved drug-induced pneumonitis, organizing pneumonia, or active pneumonitis on screening chest CT scan
    • History of relevant gastrointestinal disease, including, but not limited to, Crohn’s disease, ulcerative colitis, recurrent diverticulitis
    • Prior allogenic bone marrow transplantation or prior solid organ transplantation
    • History of HIV
    • Patients with history of HBV infection are eligible if serological profile is compatible with past/resolved infection (defined as negative HBsAg test and positive antibody to HBV core antigen [anti-HBc] antibody test) and HBsAg test and HBV-DNA are both negative prior to Cycle 1, Day 1
    • Patients with history of HCV infection must be screened for HCV-RNA PCR test prior to Cycle 1, Day 1, and are eligible if the test turns negative
    • Other serious concomitant disease, including:
    - Active tuberculosis
    - Severe infections within 4 weeks prior to Cycle 1, Day 1
    - Significant cardiovascular disease (NYHA class III or IV), myocardial infarction within the previous 6 months, unstable angina, or unstable arrhythmias
    - Significant pulmonary (asthma or COPD) or hepatic disease or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment
    • Major surgical procedures within 28 days prior to Cycle 1, Day 1
    • Concurrent medications:
    - Treatment with systemic immunosuppressive medications, including but not limited to prednisone (with specific exceptions; see below), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1.
    - The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
    - The use of systemic prednisone at the dosage of 10 mg/day or lower (or equivalent) is allowed.
    • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
    • Medisch of psychologisch belemmerd om te voldoen aan het protocol
    • Patiënten met alleen peritoneale MPM
    • Eerdere maligniteit behalve adequaat behandelde basaalcellige of plaveiselcellige huidkanker, superficieel of in-situ blaaskanker of andere kanker waarvan de patient tenminste 5 jaar ziekte vrij is.
    • Gelijktijdige deelname aan een andere klinische studie (naar de onderzoeker's oordeel)
    • Ongecontroleerde pleurale/peritoneale effusie, percardiale effusie of ascites waarvoor terugkerende drainage noodzakelijk is (1 keer per maand of vaker)
    • Ongecontroleerde tumor-gerelateerde pijn
    Patiënten, die pijnmedicatie nodig hebben moeten een stabile regimen hebben bij start van de studie
    Symptomatische lesies, die in aanmerking komen voor palliatieve radiotherapie moeten voor inclusie behandeld zijn.
    • Eerdere behandeling met elke checkpoint inhibitor
    • Zwangere en zogende vrouwen
    • Patiënten met hersenmetastasen
    • Actieve autoimmuun ziekte in de voorgeschiedenis (b.v. pneumonitis; rheumatische arthritis; ernstige vorm van psoriasis; ongecontroleerde diabetes type I of hypothyreoïdie)
    • Idiopathische longfibrose (inclusief pneumonitis) in de voorgeschiedenis of onopgeloste geneesmiddel-geinduceerde pneumonitis, organizing pneumonie, of actieve pneumonitis die zichtbaar is op de screenings CT-thorax scan
    • Relevante gastrointestinale ziekte in de voorgeschiedenis, inclusief, maar niet gelimiteerd tot de ziekte van Chrohn, ulcererende colitis, terugkerende diverticulitis
    • Eerdere allogene beenmergtransplantatie of eerdere solide orgaantransplantatie
    • Bekende voorgeschiedenis van HIV
    • Patiënten met een HBV infectie in de voorgeschiedenis zijn eligible als het serologisch profile overeenkomt met een herstelde infectie (gedefinieerd als een negatieve HBsAg test en een positief antilichaam tegen HBV core antigen (anti-HBc) antilichaam test) en de HbsAG test en HBV-DNA zijn beide negatief voor kuur 1, dag 1)
    • Patiënten met een HCV infectie in voorgeschiedenis moeten gescreend worden op HCV-RNA test voor kuur 1, dag 1 en zijn eligible als de test negatief blijkt te zijn
    • Andere serieuze gelijktijdige ziekte, inclusief:
    - Actieve tuberculose
    - Ernstige infecties binnen 4 weken voor kuur 1, dag 1
    - Significant cardiovasculaire ziekte (NYHA klasse III of IV), myocard infarct in de laatste 6 maanden, onstabiele angina, of onstabiele ritmestoornissen
    - Significante long- (astma of COPD) of leverziekte of andere ziekte die door de onderzoeker als een ongerechtvaardigd hoog risico voor de onderzoeksbehandeling wordt beschouwd.
    • Grote chirurgische handelingen binnen 28 dagen voor kuur 1, dag 1
    • Gelijktijdig gebruik van medicijnen:
    - Behandeling met systemische immunosuppresieve medicatie, inclusief maar niet gelimiteerd tot presnison (met specifieke uitzonderingen; zie hieronder), cyclofosfamide, azathioprine, methotrexate, thalidomide, en anti-tumor necrose factor (anti-TNF) middelen) binnen 2 weken voor kuur 1, dag 1.
    - Het gebruik van geinhaleerde corticosteroiden en minerale-corticosteroiden (bv, fludrocortison) is toegestaan
    - Het gebruik van systemische prednisone met een dosis van 10 mg per dag of lager (of equivalent) is toegestaan
    • Toediening van een levend, verzwakt vaccine binnen 4 weken voor kuur 1, dag 1
    E.5 End points
    E.5.1Primary end point(s)
    DCR at 12 weeks
    DCR (disease control rate) bij 12 weken
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 weeks
    Bij 12 weken
    E.5.2Secondary end point(s)
    PFS, OS, ORR, safety
    progressievrije overleving, algehele overleving, algehele respons rate, veiligheid
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS, ORR and OS: 6 weekly until week 48. Thereafter 12 weekly
    Safety: 2 weekly during treatment, thereafter every 6 weekly until week 48. Thereafter 12 weekly
    Progressievrije overleving, algehele respons rate en algehele overleving: elke 6 weken tot week 48. Daarna elke 12 weken.
    Veiligheid: elke 2 weken tijdens de behandeling, daarna elke 6 weken tot week 48. Daarna elke 12 weken.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Laatste visite van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state33
    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)
    Once patients have been discontinued from study treatment, other treatment options will be discussed at the discretion of the investigator
    Zodra patienten de studiebehandeling hebben beeindigd, zullen andere behandelingsopties besproken worden door de onderzoeker
    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 Decision2016-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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