Sample size
EVENTS
To show an increase of median PFS (from 3.5 to 5.5 months, HR 0.636), with unilateral alpha = 5% and power = 80%, 130 evaluable patients were needed for 121 events at the time of the final analysis. Randomization, to a 1:1 ratio, was stratified according to the inclusion center and the number of lines of chemotherapy (second versus third line). All efficacy analyses were conducted on the intending to treat (ITT) population. Two safety interim analyses were scheduled.