A multicenter phase I/II study of TAS-102 with nintedanib in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard therapies (N-TASK FORCE): EPOC1410.

TPS3632Background: In a RECOURSE phase III study, TAS-102 significantly improved progression-free survival (PFS) and overall survival (OS) over placebo in patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard therapies. We reported the combination of TAS-102 with bevacizumab (C-TASK FORCE trial) showed promising anti-tumor activities with mild toxicities (Kuboki Y, et al. ASCO 2015). Nintedanib is a triple angiokinase inhibitor of vascular endothelial growth factor receptors (1,2,3), platelet-derived growth factor receptors (a, β), and fibroblast growth factor receptors (1,2,3). A global phase III study, called as the LUME-Colon 1, comparing nintedanib monotherapy versus placebo in pts with mCRC refractory to standard therapies is ongoing, on the basis of promising anti-tumor activities with mild toxicities in a phase I clinical study of nintedanib monotherapy (Mross et al.). Therefore, we initiated phase I/II study to assess efficacy and safety for the combination of TAS-102 with...