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    Summary
    EudraCT Number:2011-004901-25
    Sponsor's Protocol Code Number:MEK115892
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-07-25
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2011-004901-25
    A.3Full title of the trial
    An Open-Label, Two-Period, Randomized, Crossover Study to
    Assess the Relative Bioavailability of GSK1120212 Tablet
    Formulation and the GSK1120212 Pediatric Oral Solution
    Formulation Following Single-Dose Administration to Adult
    Subjects with Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the tablet and oral solution formulations of GSK1120212 in cancer patients
    A.4.1Sponsor's protocol code numberMEK115892
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/044/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research and Development Ltd
    B.1.3.4CountryUnited States
    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 supportGSK
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442089904466
    B.5.5Fax number+442089901234
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code GSK1120212
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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.3.2Product code GSK1120212
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    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.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
    GSK1120212 is currently being developed for a number of solid tumors, including metastatic BRAF-mutant melanoma (Phase 3), pancreatic cancer (Phase 2) and non small cell lung cancer (Phase 2), and in hematological malignancies, including acute-myeloid leukemia (AML) or chronic myelo-monocytic leukemia (CMML).
    E.1.1.1Medical condition in easily understood language
    Cancer
    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 estimate the relative bioavailability of 2mg GSK1120212 pediatric oral solution formulation to 2mg of the tablet formulation of GSK1120212 in fasted subjects.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of a single 2mg dose of the pediatric oral solution formulation of GSK1120212 following administration to fasted subjects.

    To investigate the safety and tolerability of a single 2mg dose of the tablet formulation of GSK1120212 following administration to fasted subjects.

    To characterize the PK of GSK1120212 after administration of the pediatric oral solution and tablet formulation in fasted subjects.

    To investigate the palatability of the pediatric oral solution formulation of GSK1120212 following administration to fasted subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 18 years of age or older, at the time of signing the informed consent.
    2. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    3. Able to swallow and retain oral medication.
    4. Histologically- or cytologically-confirmed diagnosis of a solid tumor malignancy that is not responsive to standard therapies; or for which there is no approved or curative therapy; or for subjects which refuse standard therapy.
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    6. Adequate baseline organ function as defined in Table 4 in the protocol.
    7. Women of child-bearing potential must have a negative serum pregnancy test within 14 days of first dose of investigational product administration and agree to use effective contraception, as defined in Section 7.1.1 of the protocol, during the study and for 6 weeks following the last dose of investigational product.
    8. Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 7.1 of the protocol. This criterion must be followed from the time of the first dose of study medication until 16 weeks after
    the last dose of GSK1120212.
    E.4Principal exclusion criteria
    1. Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or major surgery) within 3 weeks prior to randomization; chemotherapy regimens without delayed toxicity within 2 weeks prior to randomization; or use of an investigational anticancer drug within 4 weeks prior to randomization.
    2. Unresolved Grade 2 or greater toxicity (based on NCI-CTCAE, version 4.0 [NCI-CTCAE, 2009]) from previous anti-cancer therapy except Grade 2 decreased haemoglobin levels or alopecia.
    3. Pre-existing peripheral neuropathy ≥ Grade 2.
    4. Has participated in a clinical trial and received investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer, prior to the first dose of investigational product in this study.
    5. Has participated in a clinical trial that resulted in or made a donation of blood or blood products in excess of 500mL within 56 days of the first dose of investigational product in this study.
    6. Has presence of active GI disease or other condition (e.g., gastrectomy, bariatric surgery, small or large bowel resection, or cholecystectomy) that may interfere significantly with absorption of drugs.
    7. Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance with the study procedures, in the opinion of the investigator or the GSK medical monitor.
    8. History of interstitial lung disease or pneumonitis.
    9. History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
    • History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease(s) such as hypertension diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).
    • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
    • Evidence of new optic disc cupping
    • Evidence of new visual field defects
    • Intraocular pressure > 21mm Hg
    10. Has symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
    NOTE: Subjects previously treated for these conditions that have had stable central nervous system (CNS) disease (verified with consecutive imaging studies) for >3 months, are asymptomatic and are not currently taking corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to Day 1 of the study are permitted. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs (EIAEDs).
    11. QTcB or QTcF ≥480msec.
    12. Subject has a history or evidence of cardiovascular risk, including any of the following:
    • History or evidence of current clinically significant uncontrolled arrhythmias. Exception: subjects with controlled atrial fibrillation for >30days prior to randomization are eligible.
    • History of acute coronary syndromes, including myocardial infarction and unstable angina, coronary angioplasty, or stenting, within 6months prior to randomization.
    13. History or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association (NYHA; Appendix 1).
    E.5 End points
    E.5.1Primary end point(s)
    The primary PK endpoints will be AUC(0-∞), AUC(0-t), and Cmax of GSK1120212. Secondary PK endpoints will be tmax and
    t1/2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK endpoints will be evaluated based on blood draws done from day 1 through day 7 of each of the two dosing periods.
    E.5.2Secondary end point(s)
    Safety and tolerability will be assessed by physical examinations, measurement of blood pressure, heart rate, laboratory safety
    screens and assessment of adverse events and serious adverse events. The secondary PK endpoint will be AUC(0-24), half-life and Tmax of GSK1120212.

    Bitterness, sweetness, overall taste and aroma will each be ranked by subjects on a 4-point scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety will be monitored from start of study dosing through to the last followup visit.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Yes
    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) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Please note that there is no controlled/comparator in this study.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Please note that there is no controlled/comparator in this study.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days20
    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: 18
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 18
    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
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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