Table 3.

Summary of efficacy data

Variable	Dose escalationn = 15	Dose expansionn = 18	All patients n = 33	800 mg cohort n = 24
Best overall response, n (%)
Complete response	0 (0)	1 (6)	1 (3)	1 (4)
Partial response	4 (27)^a	10 (56)	14 (42)^b	12 (50)
Stable disease	6 (40)	2 (11)	8 (24)	5 (21)
Progressive disease	5 (33)	5 (28)	10 (30)	6 (25)
Overall response rate	4 (27)^a	11 (61)	15 (45)^b	13 (54)
Clinical benefit rate	10 (67)	13 (72)	23 (70)	18 (75)
Median PFS (weeks)	36	48	36	51
Median duration of response (range)^c	61 (11–100+)	39 (8–83+)	42 (8–100+)	42 (8–100+)

↵^aPR and ORR was 31% for the 13 patients with measurable disease.
↵^bPR and ORR were 45% and 48%, respectively, for the 31 patients with measurable disease.
^cDuration of objective response shown for the cutoff date, with 8 patients from the 800-mg cohort remaining on study treatment.