Table 2.

Dose-escalation scheme, dose reductions, and DLTs (safety population, Q3W N = 28, Q1W N = 27)

ArmBIND-014 Dose (mg/m2)Initiala patients at this dose level (cycles)Patients reduced to this dose level (cycles)Total patients (cycles)Initiala patients with DLT
Q3W3.51 (2)0 (0)1 (2)0
71 (1)0 (0)1 (1)0
152 (4)0 (0)2 (4)0
303 (8)0 (0)3 (8)0
6014 (61)4 (33)b18 (94)1
757 (17)7 (17)2
Q1W153 (5)0 (0)3 (5)0
253 (4)1 (1)4 (5)0
306 (34)1 (1)7 (35)0
354 (10)4 (11)8 (21)0
407 (15)4 (5)c11 (20)0
454 (4)4 (4)2
  • aInitial refers to the number of patients who were initially assigned to a dose level at study entry.

  • bFour of the seven patients initially assigned to the 75 mg/m2 dose level required a dose reduction to 60 mg/m2; this dose reduction occurred after one cycle for three patients and after four cycles for one patient.

  • cFour of four patients initially assigned to the 45 mg/m2 dose level required a dose reduction to 40 mg/m2; this dose reduction occurred after one cycle for all four patients.