Table 4.

Efficacy end points

End point	Safety population (n = 50)	Efficacy population (n = 27)
Best RR (CR + PR), No. (%, 95% CI)	4 (8.0, 2.2–19.2)	4 (14.8, 4.2–33.7)
Best ORR (CR + PR + SD), No. (%, 95% CI)	6 (12.0, 4.5–24.3)	6 (22.2, 8.6–42.3)
Median response duration, months	19.1	19.1
Median PFS, months (95% CI)	4.6 (3.7–5.3)	5.3 (4.6–5.9)
Median OS, months (95% CI)	6.1 (4.0–10.4)	22.4 (6.3 - --)

RR, response rate; CR, complete response (not observed); PR, partial response; SD, stable disease; ORR, overall response rate; PFS, progression free survival; OS, overall survival