Sample Size Rationale
It was planned to enrol an initial cohort of up to 6 patients with an
oPac+E dosing regimen consisting of oral encequidar 15 mg plus an oral
paclitaxel dose of 615mg/m2 divided over 3 consecutive
days taken in once daily doses. An interim analysis of pharmacokinetic
(PK) data was conducted to determine the intrasubject variability and
geometric mean ratio (GMR) for AUC0-∞. If it appeared
likely that the selected regimen could meet the criteria for BE based on
AUC0-∞, additional subjects would be enrolled in Stage 2
at this dose. Based on this pre-planned interim analysis, an additional
34 evaluable subjects were enrolled into Stage 2. A total sample size of
40 evaluable subjects was projected to provide 90% power for the 90%
CI of the geometric mean ratio for AUC0-∞ to fall in the
range of 80% to 125%.