| Exclusion Criteria: | 1) Haematological malignancy associated with human immunodeficiency virus (HIV) infection or solid organ transplant.
2) Concurrent malignancy of solid tumors.
3) Currently receiving cancer therapy (chemotherapy, radiation therapy, immuno- therapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization). Note: For proliferative disease, hydroxyurea will be allowed during Week 1 and 2.
4) Received corticosteroids or imatinib within 24h of GSK1120212 administration.
5) Received gemtuzumab ozogamicin (myelotarg) within two weeks of GSK1120212 adminstration.
6) Received an investigational anti-cancer drug within four weeks or five half-lives, whichever is shorter of GSK1120212 administration--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.
7) Received major surgery, radiotherapy, or immunotherapy within four weeks of GSK1120212 administration.
8) Received chemotherapy regimens with delayed toxicity within the last four weeks (six weeks for prior nitrosourea or mitomycin C). Received chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last two weeks. Note: Use of hematopoetic growth factors is permitted at the discretion of the investigator according to published guidelines (e.g. NCCN, ASCO, ASH etc.).
9) Received a MEK inhibitor.
10) Current use of a prohibited medication or requires any of these medications during treatment with GSK1120212.
11) 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 requiring therapeutic levels of LMWH must receive approval from GSK Medical Monitor and be monitored appropriately as clinically indicated.
12) Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
13) History of retinal vein occlusion, central serous retinopathy or glaucoma.
14) Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for retinal vein occlusion or central serous retinopathy.
15) Intraocular pressure > 21mm Hg as measured by tonography.
16) Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
17) Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
18) Symptomatic or untreated central nervous system (CNS) involvement by the hematologic malignancy (including primary CNS lymphoma). Subjects who were previously treated for CNS involvement, and are asymptomatic without anti-epileptic medications for at least two months are eligible.
19) Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).
20) 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 GlaxoSmithKline (GSK) Medical Monitor and the investigator.
21) Corrected QT interval on electrocardiogram (QTc) interval greater than or equal to 480 msecs.
22) History of acute coronary syndromes (including unstable angina), coronary angioplasty or stenting within the past 24 weeks.
23) Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
24) Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug, dimethyl sulfoxide (DMSO), or excipients (To date there are no known FDA approved drugs chemically related to GSK1120212).
25) Pregnant or lactating female.
26) Unwillingness or inability to follow the procedures outlined in the protocol. |