The randomized, double-blind trial compares TAS-102 with best supportive care (BSC) to investigate the efficacy and safety of TAS-102 when administered to patients who are both unresectable and relapsed/refractory to standard chemotherapies.
The overall survival is the primary endpoint of the trial, beginning in Japan followed by North America, Europe and Australia.
TAS-102 combines: FTD (alpha, alpha, alpha-trifluorothymidine) and 5-chloro-6-(2-iminopyrrolidin-1-yl)-methyl-2, 4(1H, 3H)-pyrimidinedione hydrochloride (TPI), which maintains an effective blood concentration of FTD by inhibiting thymidine phosphorylase which is the primary enzyme involved in the degradation of FTD.