Abstract
10007 Background: Resistance remains a challenge in GIST after the failure of IM and SU. Regorafenib, a novel oral kinase inhibitor, blocks VEGFR2-3, c-KIT, TIE2, PDGFR beta, FGFR1, RET, RAF and p38 MAPK and has a broad spectrum of antitumor activity in preclinical and early phase trials. We conducted an investigator initiated, multi-center phase II trial of regorafenib in patients with advanced GIST after prior therapy with at least IM and SU. Methods: Eligible pts received regorafenib 160mg/day orally d1-21 of each 28d cycle. Pts were assessed for response by RECIST 1.1 every 2 cycles. Primary endpoint was clinical benefit rate (CBR) defined as CR, PR, and SD > 16 weeks. Tumor genotyping and optional pre and d15 tumor biopsies were performed. Results: 34 pts were enrolled from Feb 2010 – Dec 2010. 33 pts received at least one dose of study drug. Median age was 54 yrs, median number of prior therapies = 3. As of Dec 1, 2010, 121 cycles of regorafenib have been administered (range 1 – 11). 19 pts required...
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