Cancer Clinical Trial
Official title:
An Open-Label, Two Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212 in Combination With the AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Multiple Myeloma
The purpose of this study is to determine whether the MEK inhibitor and the AKT inhibitor can be given in combination and if the combination is effective treatment for patients with solid tumors, including breast cancer and endometrial cancer, and for patients with multiple myeloma.
This is an open-label, two part, Phase I/II study to investigate the safety,
pharmacokinetics, pharmacodynamics, and clinical activity of the MEK inhibitor GSK1120212
administered in combination with the AKT inhibitor GSK2110183 in subjects with solid tumors
and multiple myeloma.
In Part 1, the safety and tolerability of a range of doses for GSK1120212 and GSK2110183
dosed in combination will be investigated; pharmacokinetics will also be analyzed to
determine whether there is a drug-drug interaction between GSK1120212 and GSK2110183 when
dosed in combination.
The second part of the study will focus on evaluation of the clinical efficacy of the
combination as well as the pharmacodynamic response in subjects with proteasome-refractory
multiple myeloma (Part 2A) or solid tumors, putatively endometrial and triple negative breast
cancer (Part 2B).
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