Kosan initiates Phase II lung cancer trial

The Phase II trial is an open-label, multi-center, monotherapy study of KOS-1584 in patients with measurable advanced or metastatic non-small cell lung cancer who have previously received only one prior chemotherapy regimen. The primary endpoint of the Phase II trial is objective response rate.

Secondary endpoints include progression-free survival, time to progression, time to treatment failure, time to response, duration of response and overall survival. KOS-1584 will be administered via a three-hour intravenous infusion weekly for two weeks out of every three weeks at a dose of 25mg/m(2). The Phase II trial will enroll up to 50 patients in a two-stage Simon design.

Helen Kim, president and CEO of Kosan, said: “We have been impressed by the breadth and level of activity and tolerability we have observed with KOS-1584 in our Phase I trials and believe that KOS-1584 has competitive potential in the emerging epothilone class of anticancer agents.”