The previously announced phase II randomized study will compare AZD6244 to temozolomide in the treatment of stage III / IV melanoma patients. AstraZeneca expects to enroll up to 180 patients at approximately 40 centers worldwide. Additional phase II studies, in a range of other tumors, are scheduled to start this year.
The Phase I study clearly demonstrated that AZD6244 inhibits MEK and associated downstream markers in tumors at doses deemed well tolerated. The full results of this study will be published later in the year.
MEK inhibition is an attractive anti-cancer strategy as it has the potential to block inappropriate signal transduction regardless of the upstream position of the oncogenic aberration.