A randomized phase III study of napabucasin [BBI608] (NAPA) vs placebo (PBO) in patients (pts) with pretreated advanced colorectal cancer (ACRC): the CCTG/AGITG CO.23 trial

Abstract

282 pts were randomized (138 NAPA, 144 PBO) from 04/2013 - 05/2014 when the trial was unblinded, accrual closed, and protocol treatment stopped after the futility analysis. Pts were median age = 64 (32 to 85); male = 65%; ECOG 0:1 (%) =28:72; >4 prior regimens = 98%; prior anti-VEGF = 89%; KRAS WT = 52%. No significant difference was observed in OS, progression free survival (PFS) or DCR between NAPA and PBO in the ITT analysis. AE more frequent with NAPA included: any grade diarrhea (88 vs 32%), nausea (63 vs 47%), and anorexia (56 vs 46%), all p \r\r