[RESULTS] The observed 6-month PFS rate was 43.5 % ( 95 % confidence interval ( CI ) , [ 28.6-58 .4 % ] ) in arm A reaching the Fleming decision rules criteria to reject H0 and 26.1 % ( 95 % CI [ 12.9-39 .3 % ] ) in arm B. Objective response rates were 37 % ( 23-51 % ) in arm A and 10 % ( 1-19 % ) in arm B. Median PFS ( 5.0 versus 3.4 months , hazard ratio ( HR ) = 0.59 [ 0.38-0 .90 ] ) and overall survival ( 11.0 versus 8.2 months , HR = 0.71 [ 0.46-1 .10 ] ) were higher in arm A compared to arm B.