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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2009-017477-38
    Sponsor's Protocol Code Number:MEK112110
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-18
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-017477-38
    A.3Full title of the trial
    An Open-Label, Dose-Escalation, Phase IB/ II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor GSK1120212 in Combination with Oral Everolimus in Subjects with Solid Tumors
    A.4.1Sponsor's protocol code numberMEK112110
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGSK1120212
    D.3.2Product code GSK1120212
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1187431-43-1
    D.3.9.2Current sponsor codeGSK1120212
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameGSK1120212
    D.3.2Product code GSK1120212
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1187431-43-1
    D.3.9.2Current sponsor codeGSK1120212
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameRAD001
    D.3.2Product code everolimus
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNeverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRAD001
    D.3.2Product code everolimus
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNeverolimus
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Solid Tumors
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1B component: To determine the safety, tolerability and recommended Phase II dose and regimen of GSK1120212 and everolimus dosed orally in combination.

    Phase II component: To determine clinical activity of GSK1120212 and everolimus in subjects with KRAS-mutant NSCLC.
    E.2.2Secondary objectives of the trial
    Phase 1B component:
    1) To characterize the steady-state PK of GSK1120212 and everolimus
    2) To evaluate the clinical activity of GSK1120212 and everolimus in subjects with solid tumors and pancreatic cancer.
    3) To determine if changes in CA 19-9 levels correlate with radiographic response in subjects with pancreatic cancer

    Phase II component:
    1) To characterize the population pharmacokinetics (PK) parameters of GSK1120212 and everolimus when administered daily in subjects with KRASmutant NSCLC.
    2) To characterize the durability of response in subjects achieving clinical benefit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria
    apply:

    1. Capable of giving written informed consent, which includes compliance with the
    requirements and restrictions listed in the consent form.

    2. Age 18 years old or older and able to swallow oral medication.

    3. Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology
    (ECOG) scale for Phase IB/Dose Escalation Cohort. Subjects with ECOG PS of 2
    can be enrolled for Phase IB/Expansion Cohort and Phase II.

    4. Tumor Type criteria:

    • Phase IB/Dose Escalation Cohort
    o Histologically or cytologically confirmed diagnosis of solid tumor malignancy:
    That is relapsed/refractory
    OR is potentially responsive to everolimus
    OR for which there is no standard or curative therapy
    OR for subjects who refuse standard therapy

    • Phase IB/Expansion Cohort
    o Pancreatic cancer: Histologically or cytologically confirmed diagnosis of metastatic pancreatic cancer. Subjects with locally advanced surgically unresectable disease are also eligible.
    o Measurable disease by RECIST 1.1.

    • Phase II
    o KRAS- mutant NSCLC: Histologically or cytologically confirmed diagnosis of metastatic NSCLC
    o Measurable disease by RECIST 1.1 [Eisenhauer, 2009].

    5. Fasting glucose < 126mg/dL

    6. Male subjects must agree to use one of the contraception methods listed in
    Section 7.1.2. This criterion must be followed from the time of the first dose of
    study medication until 4 weeks after the last dose of study medication. However, the
    Sponsor advises that contraception be used for a total of 16 weeks following the last
    dose (based on the lifecycle of sperm).

    7. A female subject is eligible to participate if she is of:
    • Non-childbearing potential defined as pre-menopausal females with a
    documented tubal ligation or hysterectomy; or postmenopausal defined as 12
    months of spontaneous amenorrhea [in questionable cases a blood sample with
    simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol <
    40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement
    therapy (HRT) and whose menopausal status is in doubt will be required to use
    one of the contraception methods in Section 7.1.1 if they wish to continue their
    HRT during the study. Otherwise, they must discontinue HRT to allow
    confirmation of post-menopausal status prior to study enrollment. For most
    forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy
    and the blood draw; this interval depends on the type and dosage of HRT.
    Following confirmation of their post-menopausal status, they can resume use of
    HRT during the study without use of a contraceptive method.
    • Child-bearing potential and agrees to use one of the contraception methods listed
    in Section 7.1 for an appropriate period of time (as determined by the product
    label or investigator) prior to the start of dosing to sufficiently minimize the risk
    of pregnancy at that point. Female subjects must agree to use contraception until
    4 weeks after the last dose of study medication.
    Note: Oral contraceptives are not reliable due to potential drug-drug interaction

    8. Calcium phosphate product ≤ 4.0 mmol2/L2 (50 mg2/dL2)

    9. Adequate organ system function as defined in Table 10 of the protocol
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria
    apply:
    1. Malignancies related to HIV or solid organ transplant.
    2. Primary malignant brain tumors.
    3. Chemotherapy, radiotherapy, or immunotherapy within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of GSK1120212. Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity are permitted with approval of a GSK Medical Monitor if dosing of that agent is terminated at least 14 days prior to the first dose of GSK1120212.
    4. Use of an investigational anti-cancer drug within 28 days or 5 half-lives, whichever
    is shorter preceding the first dose of GSK1120212 – as long as a minimum of 14
    days has passed between the last dose of the prior investigational anti-cancer drug
    and the first dose of GSK1120212.
    5. Previous treatment with an mTOR inhibitor unless approved by GSK Medical
    Monitor.
    6. Previous treatment with GSK1120212.
    7. History of sensitivity to any of the study medications, or components thereof or a
    history of drug or other allergy that, in the opinion of the investigator or GSK
    Medical Monitor, contraindicates their participation.
    8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
    chemically related to the study drug, DMSO, or excipients (see GSK1120212
    Investigator Brochure [GlaxoSmithKline Document Number RM2007/00107/00].
    (To date there are no known FDA approved drugs chemically related to
    GSK1120212).
    9. Use of a prohibited medication (as defined in Section 8.2).
    10. Current use of anticoagulants (e.g. warfarin, heparin) at therapeutic levels within
    seven days prior to the first dose of GSK1120212. Low dose (prophylactic) low
    molecular weight heparin (LMWH) is permitted provided that subject’s PT and PTT
    meet entry criteria. Subjects required therapeutic levels of LMWH must receive
    approval from GSK Medical Monitor and monitored appropriately as clinically
    indicated.
    11. Gastrointestinal disease predicted to interfere with absorption of an oral drug,
    systemic disease, major surgery, or social/psychological issues that in the opinion of
    investigators would jeopardize compliance with protocol.
    12. History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
    13. Predisposing factors to RVO including uncontrolled hypertension, uncontrolled
    diabetes, uncontrolled hyperlipidemia, and coagulopathy.
    14. Visible retinal pathology as assessed by ophthalmologic exam that is considered a
    risk factor for RVO or CSR.
    15. Intraocular pressure > 21mm Hg as measured by tonography.
    16. Glaucoma diagnosed within 1 month prior to study Day 1.
    17. Symptomatic or untreated leptomeningeal or brain metastases or spinal cord
    compression. Subjects previously treated for these conditions that are asymptomatic
    and off corticosteroids for at least two weeks are permitted. Subjects are not
    permitted to receive enzyme inducing anti-epileptic drugs (EIAEDs).
    18. Unresolved toxicity greater than common terminology criteria for adverse events
    (CTCAE) grade 1 from previous anti-cancer therapy except alopecia (if applicable)
    unless agreed to by a GSK Medical Monitor and the Investigator.
    19. History of acute coronary syndromes (including unstable angina), coronary
    angioplasty, or stenting within the past 24 weeks.
    20. QTc interval ≥ 480 msecs.
    21. Class II, III, or IV heart failure as defined by the New York Heart Association
    (NYHA) functional classification system.
    22. Pregnant or lactating female.
    23. History or active hepatitis B or C.
    24. History of HIV infection.
    25. Subjects on chronic antifungal therapy.
    26. Unwillingness or inability to follow the procedures outlined in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1B:
    AEs and changes in laboratory values and vital signs.

    Phase II:
    Response rate (CR + PR) of GSK1120212 and everolimus in KRAS-mutant NSCLC.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation (Ph1B) followed by confirmatory efficacy (PhII) in NSCLC
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the last subject’s last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-03-18. Yes
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 100
    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)
    Subjects will receive standard of care treatment as determined by their health care
    provider after completion of the study. Please see Section 9.4 of the protocol
    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 Decision2010-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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