Table 3.

Efficacy Analyses

	Schedule 1* MTD (1.88 mg/kg; n = 43†)		Schedule 2‡ MTD (1.5 mg/kg; n = 6)		Schedule 3§ MTD (1.0 mg/kg; n = 15)		All MTDs Combined (N = 64)
Parameter	No.	%	No.	%	No.	%	No.	%
Best response‖
PR	5 of 40	13¶	2 of 6	33	3 of 12	25	10 of 58	17
SD or better	27 of 40	68	3 of 6	50	7 of 12	58	37 of 58	64
Time to response, months
Median	1.6		1.3, 2.6#		1.2, 1.5, 3.7#		1.6
Range	1.4-2.7						1.2-3.7
Duration of response, months
Median	5.3		3.5, 9.0+#		3.4, 7.3, 9.5#		5.5
Range	2.8-10.6						2.8-10.6
Progression-free survival
Median, months	3.3		3.1		1.5		2.8
95% CI	1.6 to 4.4		0.5 to NE		1.0 to 5.7		1.4 to 4.4
Six-month rate	24		33		20		24
95% CI	20 to 27		21 to 46		16 to 24		21 to 26

Abbreviations: MTD, maximum-tolerated dose; NE, not estimated; PR, partial response; SD, stable disease.

^*Schedule 1: once every 3 weeks.

^†Includes all patients who received the 1.88 mg/kg dose, including those treated in the dose-escalation and expansion phases. Five (15%) of the 34 assessable patients in schedule 1 (once every 3 weeks) MTD expansion cohort experienced a PR.

^‡Schedule 2: once per week for 2 of 3 weeks.

^§Schedule 3: once per week.

^‖Excludes patients without postbaseline assessment of measurable lesions.

^¶Including one response (93% tumor shrinkage) that was not sustained at the subsequent assessment.

^#Individual patient data are listed in cases where the sample size was < 5.