GSK1120212 Food-effect study

A subject will not be eligible for inclusion in this study if any of the following criteria apply: 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 anti-cancer drug within 4 weeks prior to randomization. 2. Has unresolved Grade 2 or greater toxicity (based on NCI-CTCAE, version 4.0) [NCI Common Terminology Criteria for Adverse Events, 2009] from previous anti-cancer therapy except Grade 2 decreased hemoglobin levels or alopecia. 3. Has pre-existing peripheral neuropathy of greater than or equal to Grade 2. 4. Has participated in a clinical trial and has received an 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 study treatment in this study. 5. Has participated in a study that resulted in or made a donation of blood or blood products in excess of 500 mL within 56 days of the first dose of study treatment. 6. Has presence of active GI disease or other condition (e.g., gastrectomy, bariatric surgery, small or large bowel resection, or cholecystectomy should be excluded) that may interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GSK Medical Monitor. 7. Has 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 to the study procedures, in the opinion of the investigator or GSK Medical Monitor. 8. Has a history of interstitial lung disease or pneumonitis. 9. Is currently using a prohibited medication(s) or requires the use of any of the prohibited medications during the study (see Section 8.2).

• NOTE: Use of anticoagulants such as warfarin is permitted; however, INR must be monitored in accordance with local institutional practice. 10. Has a history or current evidence/risk of RVO or CSR:
• History of RVO or CSR, or predisposing factors to RVO or CSR (i.e., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension or 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
• Intraocular pressure greater than 21 mmHg as measured by tonography 11. 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 greater than 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). 12. Has a QtcB or QTcF (preferred) greater than or equal to 480 msec. 13. Has a history or evidence of cardiovascular risk including any of the following: 14. History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for greater 30 days prior to randomization are eligible. 15. History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization. 16. History or evidence of current greater than or equal to Class II congestive heart failure as defined by New York Heart Association (NYHA) (Appendix 4).