Table 3.

Summary of efficacy data

VariableDose escalationn = 15Dose expansionn = 18All patients n = 33800 mg cohort n = 24
Best overall response, n (%)
 Complete response0 (0)1 (6)1 (3)1 (4)
 Partial response4 (27)a10 (56)14 (42)b12 (50)
 Stable disease6 (40)2 (11)8 (24)5 (21)
 Progressive disease5 (33)5 (28)10 (30)6 (25)
 Overall response rate4 (27)a11 (61)15 (45)b13 (54)
 Clinical benefit rate10 (67)13 (72)23 (70)18 (75)
Median PFS (weeks)36483651
Median duration of response (range)c61 (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.