A Phase 1, Open-Label, Dose Escalation Study Of Amg 337 In Asian Patients (Pts) With Advanced Solid Tumors

e13538 Background: In the first-in-human study of AMG 337, an investigational, selective, oral MET kinase inhibitor, in Western pts with advanced solid tumors, headache was the main adverse event (AE); AMG 337 doses up to 300 mg QD were tolerated. This study assessed tolerability and safety, including dose-limiting toxicities (DLTs), of AMG 337 in Asian pts with advanced solid tumors. Methods: Eligible pts were Asian, aged ≥20 years, with ECOG PS ≤2 and pathologically confirmed, advanced solid tumors for which prior Tx for advanced disease was received, no standard Tx exists, or standard Tx was refused. Pts enrolled in a 3+3+3 dose escalation scheme. Two cohorts (AMG 337 150 and 300 mg QD) received AMG 337 orally in 28-day cycles. After all pts in a cohort completed a 28-day safety observation period, a dose-level review meeting was convened to determine whether DLT criteria had been met for dose escalation. Endpoints: AEs and DLTs. Results: As of JUN 18, 2014, cohort 1 (AMG 337 150 mg QD) enrolled 4 Japa...