MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors and Leukemia
1. Has provided signed informed consent for this study.
2. Has demonstrated compliance during the parent study with study treatment(s),
treatment visit schedules, and the requirements and restrictions listed in the
3. Is currently participating in GSK1120212 study and is receiving treatment with
4. Is currently receiving clinical benefit as determined by the investigator from
previous treatment with GSK1120212 either as monotherapy or as part of a combination
5. Continued ability to swallow and retain orally administered study treatment(s) and
does not have any clinically significant GI abnormalities that may alter absorption
such as malabsorption syndrome or major resection of the stomach or bowels.
6. Female subjects of childbearing potential, as defined in the parent study, must be
willing to continue practicing the same acceptable method of contraception as used in
the parent study during the rollover study and for at least 4 months after the last
dose of GSK1120212.
7. Female subjects of childbearing potential, as defined in parent study, must have
negative serum pregnancy tests at the time of transition to this study.
8. Subjects enrolled in France: In France, a subject will be eligible for inclusion in
this study only if either affiliated to or a beneficiary of a social security
1. Permanent discontinuation of GSK1120212 in the parent study due to toxicity or
2. Local access to commercially available GSK1120212.
3. Current use of a prohibitive medication(s) as listed in Section 6.2. NOTE: Use of
anticoagulants such as warfarin is permitted; however, the international
normalization ratio (INR) must be monitored in accordance with local institutional
4. Any unresolved toxicity that meets the study treatment discontinuation or study
withdrawal criteria from the parent study at the time of transition to this study.
5. Bazett-corrected QT (QTcB) interval ≥501 msec at the time of transition to this study
6. Left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN)
by ECHO (preferred) or MUGA scan at the time of transition to this study.
7. Nursing female.
8. Any serious and/or unstable pre-existing medical, psychiatric disorder or other
conditions at the time of transition to this study 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.