Table 4.

Correlation of treatment toxicity and efficacy with maximum concentration (Cmax) and area under the concentration–time curve from time zero to t [AUC (0-t)] of axitinib, measured at cycle 2, day 1 for subjects taking axitinib at 5 mg twice daily from cycles 1 to 2

Cmax (ng/mL)AUC(0-t) (ng*h/mL)
ParametersNGeometric mean (CV, %)Geometric mean (CV, %)
Treatment-related toxicity by CTCAE grading in cycle 1
 Grade 0–11027.6 (59)60.5 (47)
 Grade 2–31546.0 (62)105.3 (73)
P valuea0.0350.028
Tumor response at cycle 2 (excluding 5 subjects with dose change)
 PRb466.6 (56)171.6 (75%)
 SD/PDb15/137.2 (61)82.5 (56)
P valuea0.0760.029
  • aTo compare the mean between groups, P value was obtained by a t test.

  • bPR, partial response; SD, stable disease; PD, progressive disease.

  • %CV, Coefficient of variation.