On March 5, 2014 Verastem presented preliminary data from an ongoing First-in-Asia Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors, including one patient with mesothelioma. The Phase 1 study assessed the safety and pharmacokinetics of single agent VS-6063 (Press release Verastem, MAR 5, 2014, View Source;p=RssLanding&cat=news&id=1906472 [SID:1234500516]).
Verastem’s ongoing COMMAND trial is a randomized, double-blind, placebo controlled registration-directed study which is evaluating VS-6063 in patients with mesothelioma and is currently accruing patients in 8 countries.
The Japanese Phase 1 is an open-label, dose-escalation study that enrolled nine subjects who received single-agent VS-6063 (200, 400 or 600mg; n=3 in each dose cohort) BID. The study results demonstrated that VS-6063 was well tolerated at all dose levels. There were no serious adverse events or evidence of dose-limiting toxicity. Pharmacokinetic results from the recommended Phase 2 dose of 400mg BID were consistent with previously reported data in non-Japanese subjects. These safety and pharmacokinetic results support advancing the VS-6063 development program in Japanese patients.

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