Table 5.

PK parameters of BIND-014 on day 1, cycle 1 for total docetaxel (data expressed as mean ± SD, PK population, Q3W N = 28, Q1W N = 27)

ArmDose (mg/m2)% EncapsulatedTmax (h)Cmax (μg/mL)Cmax/Dose (μg/mL/mg/m2)Cmin (μg/mL)AUC (h*μg/mL)AUC/Dose (h*μg/mL/mg/m2)t1/2 (h)CL (L/h/m2)Vd (L/m2)
Q3W3.5 (N = 1)93.1%1.021.750.500.004310.112.894.220.352.10
7 (N = 1)101.3%1.023.580.510.040830.834.408.780.222.83
15 (N = 2)99.2%1.297.770 (1.85)0.520.017163.48 (1.95)4.235.180.24 (0.01)1.77 (0.40)
30 (N = 3)86.6%1.3512.54 (3.08)0.420.0576115.37 (37.59)3.856.070.28 (0.11)2.44 (0.81)
60 (N = 14)91.4%1.3224.88 (7.52)0.410.1196218.77 (74.30)3.656.350.43 (0.59)3.95 (5.87)
75 (N = 7)99.0%1.4236.77 (4.49)0.490.1840344.53 (73.25)4.596.000.23 (0.06)1.91 (0.31)
Q1W15 (N = 3)105.7%1.065.78 (2.24)0.390.031855.36 (27.82)3.696.100.69 (0.45)5.79 (3.43)
25 (N = 3)102.5%1.1010.04 (0.61)0.400.032576.47 (14.50)3.066.110.69 (0.12)6.02 (0.87)
30 (N = 6)99.3%1.0312.90 (4.17)0.430.0692118.75 (47.70)3.966.300.66 (0.50)5.47 (2.89)
35 (N = 4)103.8%1.0515.93 (3.00)0.460.0870144.70 (29.03)4.136.560.46 (0.12)4.34 (1.14)
40 (N = 7)101.4%1.1615.52 (5.19)0.390.0626140.48 (57.99)3.515.770.66 (0.35)5.19 (2.09)
45 (N = 4)99.6%1.2820.48 (3.89)0.460.1122194.92 (38.07)4.336.470.42 (0.09)3.85 (0.64)
  • Abbreviation: PK, pharmacokinetic.