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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41451   clinical trials with a EudraCT protocol, of which   6809   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2015-004260-10
    Sponsor's Protocol Code Number:52009
    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:2016-12-01
    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 number2015-004260-10
    A.3Full title of the trial
    89Zirconium-labeled pembrolizumab as predictive imaging biomarker of response and toxicity in pembrolizumab treated patients with non-small-cell lung cancer – a feasibility study
    89Zirconium gelabeled Pembrolizumab als voorspellende biomarker van respons en toxiciteit in patiënten met niet-kleincellig longkanker die worden behandeld met Pembrolizumab – een haalbaarheidsstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    89Zirconium-labeled pembrolizumab in pembrolizumab treated patients with non-small-cell lung cancer – a feasibility study
    89Zirconium gelabeled Pembrolizumab in patiënten met niet-kleincellig longkanker die worden behandeld met Pembrolizumab – een haalbaarheidsstudie.
    A.4.1Sponsor's protocol code number52009
    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 SponsorVU Medical Centre
    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 supportMerck Sharp & Dohme
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU Medical Centre
    B.5.2Functional name of contact pointSecretariaat Longziekten
    B.5.3 Address:
    B.5.3.1Street Addressde Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204444782
    B.5.5Fax number0031204444328
    B.5.6E-maillong@vumc.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 namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Yes
    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 name89Zr-pembrolizumab
    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 INNPEMBROLIZUMAB
    D.3.9.3Other descriptive namePembrolizumab
    D.3.9.4EV Substance CodeSUB167136
    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 Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stadium IV Non-small cell lung cancer
    Stadium IV Niet kleincellig longcarcinoom
    E.1.1.1Medical condition in easily understood language
    Lungcancer
    Longkanker
    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
    To assess the safety and biodistribution of 89Zr-pembrolizumab and its uptake in tumor and target irAE tissues
    Het onderzoeken van de veiligheid en biodistributie van 89Zr-pembrolizumab en de opname daarvan in de tumor en in weefsels die gevoelig zijn voor immuungerelateerde bijwerkingen.
    E.2.2Secondary objectives of the trial
    Correlate 89Zr-pembrolizumab tumor uptake with tumor and TIL PD-1 and PD-L1 expression as well as other blood and tissue parameters as outlined in section 7.1.2.7.
    Correlate 89Zr-pembrolizumab organ uptake with irAEs. The focus will be on the gut, lung, liver, thyroid and pituitary.
    Assess uptake (visual and quantitatively expressed as SUVmax, SUVmean and SUVpeak) of 89Zr-pembrolizumab in normal tissues to evaluate the biodistribution and dosimetry.
    Het correleren tussen 89Zr-pembrolizumab tumor opname in de tumor en tumor infiltratieve lymfocyten PD-1 en PD-L1 expressie en andere bloed en weefsel parameters. Het correleren van 89Zr-pembrolizumab orgaan opname met immuungerelateerde bijwerkingen. Het onderzoeken van de opname (visueel en kwantitatief, uitgedrukt als SUVmax, SUVmean en SUVpeak) van 89Zr-pembrolizumab in normale weefsels om de biodistributie en de dosimetrie te evalueren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Have a histologically or cytologically confirmed diagnosis of stage IV, EGFR wt and EML4/ALK fusion negative NCSLC and have received at least one line of platinum based doublet chemotherapy and disease progression by RECIST 1.1 on the last systemic treatment.
    Be willing and able to provide written informed consent/assent for the trial.
    Be 18 years of age or older on day of signing informed consent.
    Have measurable disease based on RECIST 1.1.
    Must provide newly obtained tissue from a core or excisional biopsy of a tumor lesion and are willing to undergo a second biopsy when the 89Zr-pembrolizumab PET scan shows heterogeneous uptake.
    Have a performance status of 0-2 on the ECOG Performance Scale.
    Demonstrate adequate organ function.
    Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
    Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
    Histologische of cytologische bevestigde diagnose van stadium IV NSCLC, wildtype EGFR en EML4/ALK fusie negatief en op zijn minst een lijn platinum behoudende chemotherapie en progressie van ziekte na de laatste systemische behandeling.
    Patienten dienen wilsbekwaam te zijn en in staat het informed consent te tekenen.
    18 jaar of ouder op de dag van het tekenen van informed consent
    Meetbare ziekte op basis van RECIST 1.1.
    Bereid zijn tot het ondergaan van een biopt van de tumor en ook voor een tweede biopt als de 89Zr-pembrolizumab PET scan heterogene opname laat zien.
    Een performance status van 0-2 hebben op de ECOG performance schaal.
    Adequate orgaanfunctie.
    Vrouwelijke proefpersonen die in potentie zwanger kunnen zijn zouden een negatieve urine of serum zwangerschapstest moeten hebben in de 72 uur voor aanvang van de eerste gift van het studie medicament.
    Vrouwelijke proefpersonen die in potentie zwanger kunnen zijn moeten bereid zijn om twee methoden van anticonceptie te gebruiken, of gesteriliseerd zijn, of zich onthouden van heteroseksuele activiteit voor de duur van de studie tot 120 dagen na de laatste gift van de studie medicatie.
    Mannelijke patienten moeten bereid zijn tot een adequate methode van anticonceptie gedurende de eerste gift van het studie medicament tot 120 dagen na de laatste gift van de studie medicatie.
    E.4Principal exclusion criteria
    Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
    Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in a dose higher than the equivalent of 10 mg prednisolone once daily or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
    Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
    Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with asymptomatic CNS metastases are allowed to enter the study. Subjects with previously treated brain metastases may participate provided they are stable and are not using steroids for at least 7 days prior to trial treatment.
    Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study.
    Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
    Has an active infection requiring systemic therapy.
    Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
    Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
    Has received > 30 Gy of thoracic radiotherapy within 6 months of starting Pembrolizumab.
    Has received a live vaccine within 30 days prior to the first dose of trial treatment.
    Neemt deel aan of heeft deelgenomen aan een studie met een experimenteel middel of device in de vier weken voor de eerste gift van de studie.
    Heeft een immuundeficientie of ontvangt systemische steroiden in een dosis hoger dan een equivalent van 10 mg prednison per dag of elke andere vorm van immuunsuppressiva in de 7 dagen voorafgaand aan de eerste gift van het studiemedicament.
    Heeft een monoclonaal antilichaam gehad in de vier weken voorafgaand aan studie dag 1 of is niet hersteld van bijwerkingen van middelen die vier weken eerder zijn gegeven.
    Heeft chemotherapie, targeted small molecule therapie of radiotherapie gehad in de twee weken voor studie dag 1 of is niet hersteld van de bijwerkingen ten gevolge van die behandeling.
    Heeft een tweede primaire tumor die progressie vertoond of actieve behandeling vereist. Dit geldt niet voor basaalcelcarcinoom van de huid, plaveiselcelcarcinoom van de huid, of in situ cervix carcinoom, waarvoor in intentie curatieve therapie.
    Heeft symptomatische hersenmetasen en/of meningeale metastasering. Patienten met asymptomatische hersenmetastasen mogen deelnemen aan de studie. Patienten met eerder behandelde hersenmetastasen mogen deelnemen als zij stabiel zijn en als zij geen steroiden hebben gebruikt in de 7 dagen voor start van de studie.
    Heeft een actieve auto-immuunziekte welke systemische therapie heeft vereist in de afgelopen 3 maanden of bij een voorgeschiedinis met een klinisch ernstige auto-immuun ziekte, of een syndroom dat behandeling met systemische steroiden of immunosuppressiva vereist. Patienten met vitiligo of voorbijgaande astma/atopie op kinderleeftijd. Patienten met intermitterend gebruik van bronchodilatoren of lokale steroid injecties worden niet geexludeerd van de studie. Patienten met stabiele hypothyreoidie op hormoon substitutie of het syndroom van Sjogren worden niet geexcludeerd van de studie.
    Heeft aanwijzingen voor interstitiele longziekten of een actieve, niet infectieuze pneumonitis.
    Heeft een actieve infectie welke systemische therapie vereist.
    Heeft een voorgeschiedinis of momenteel aanwijzingen voor enige conditie, therapie of abnormale labuitslagen, welke de resultaten van deze studie kunnen beinvloeden, interfereren met deelname aan de studie voor de gehele duur van de studie of is, volgens de behandelend onderzoeker, niet in het belang van de patient om deel te nemen.
    Is bekend met een psychiatrische ziekten, of middelenmisbruik wat zou interfereren met de cooperatie van de vereisten van de studie.
    Is zwanger of geeft borstvoeding, of is in verwachting van kinderen binnen de geprojecteerde duur van de studie, te starten binnen de pre-screening of screening visite gedurende 120 dagen na de laatste gift van de studie.
    Heeft eerdere therapie ontvangen met anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 of anti-cytotoxische T-lymfocyteb-geassocieerd antigen-4 (CTLA-4) antilichaam (inclusief ipilimumab of andere antilichamen of medicijnen specifiek gericht op T-cellen co-stimulatie of checkpoint pathways).
    Heeft een voorgeschiedenis van HIV.
    Is bekend met een actieve Hepatitis B of C.
    Heeft meer dan 30 Gy thoracale radiotherapie gehad in de 6 maanden voorafgaand het starten met Pembrolizumab.
    Is gevaccineerd met een levend vaccin in de 30 dagen voor de eerste gift van het studie medicament.
    E.5 End points
    E.5.1Primary end point(s)
    To assess safety and to detect 89Zr-pembrolizumab uptake in tumor lesions
    Het onderzoeken van de veiligheid en de opname van 89Zr-pembrolizumab in tumor laesies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years.
    2 jaar.
    E.5.2Secondary end point(s)
    Correlate 89Zr-pembrolizumab tumor uptake with tumor and TIL PD-1 and PD-L1 expression as well as other blood and tissue parameters as outlined in section 7.1.2.7.
    Correlate 89Zr-pembrolizumab organ uptake with irAEs. The focus will be on the gut, lung, liver, thyroid and pituitary.
    Assess uptake (visual and quantitatively expressed as SUVmax, SUVmean and SUVpeak) of 89Zr-pembrolizumab in normal tissues to evaluate the biodistribution and dosimetry.
    Het correleren tussen 89Zr-pembrolizumab tumor opname in de tumor en tumor infiltratieve lymfocyten PD-1 en PD-L1 expressie en andere bloed en weefsel parameters. Het correleren van 89Zr-pembrolizumab orgaan opname met immuungerelateerde bijwerkingen. Het onderzoeken van de opname (visueel en kwantitatief, uitgedrukt als SUVmax, SUVmean en SUVpeak) van 89Zr-pembrolizumab in normale weefsels om de biodistributie en de dosimetrie te evalueren.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 jaar
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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
    LVLS
    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 months6
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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
    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 Decision2016-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-06
    P. End of Trial
    P.End of Trial StatusOngoing
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