Table 3.

Pharmacokinetic data for GRN1005

ParameterMeana
Dose, mg/m260120200300420500550650700
n33375 or 6b33206
Cmax, μg/mL30.055.2119160232210238306376
Cmax, μmol/L5.8710.823.331.345.441.146.659.973.6
Tmax, h0.170.170.170.140.400.170.000.330.08
AUCinf, μg h/mL1402616648181,3691,5321,8102,5713,322
AUCinf, μmol/L h27.451.1130160268300354503650
t1/2, h2.572.943.523.193.733.723.574.003.96
CL, mL/m2 h428470302381324343326285228
Vd, mL/m21,5901,9471,5371,7691,5651,7991,6751,6661,312

Abbreviations: AUCinf = area under the drug concentration–time curve from time zero to infinity; CL = clearance; Cmax = maximum observed drug concentration; t1/2 = half-life; Tmax = time to maximum observed drug concentration; and Vd = apparent volume of distribution.

  • aData from one patient treated at 30 mg/m2 and one patient treated at 500 mg/m2 were not included in the pharmacokinetic data as these patients did not receive a complete infusion.

  • bn = 5 for Cmax, Tmax, AUCinf, Vd and n = 6 for half-life and CL.