Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer

GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase
activity and has demonstrated potent anti-proliferative activity against human pancreatic
cancer cell lines. This study is a Phase II, randomized placebo-controlled trial of the MEK
inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with
metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with
oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria
are met. The primary objective will be to compare the overall survival of subjects in the
GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary
objectives include comparison of progression free survival, overall response rate, and
duration of response between the two arms. Exploratory research objectives include the
evaluation of population pharmacokinetics as well as blood and tissue based biomarkers.
Safety will also be monitored throughout dosing.

Once the determined number of survival events has occurred, if subjects are eligible, they
will have the option to enter MEK114375, an open-label, Phase Ib rollover study of
GSK1120212 monotherapy or GSK1120212 in combination with other anti-cancer treatments.