Table 2.

Pharmacokinetic data.

Plasma released docetaxel (n = 26)GEM CPC63495% CIGEM conventional docetaxel95% CIRDa95% CIP value
 AUCinf (mg*h/mL)7.416.63–8.295.745.09–6.48+27%12–440.001
 Cmax (mg/mL)0.2620.241–0.2842.882.59–3.20−91%−92 to −90<0.001
Plasma total docetaxel (n = 26)
 AUCinf (mg*h/mL)1,5301,450–1,6305.745.09–6.4826,500%23,100–30,400<0.001
 Cmax (mg/mL)44.442.1–46.82.882.59–3.201,440%1,280–1,610<0.001
Intratumoral concentrations (n = 24)
 Intratumoral released docetaxel (ng/mg)0.740.582–0.9410.5990.403–0.892+17%−22 to 770.43
 Intratumoral total docetaxel (ng/mg)3.412.56–4.550.5990.403–0.892+461%243–816<0.001
Half-life (T1/2) (n = 26)Median CPC634IQRMedian conventional docetaxelIQRP value
 Released docetaxel (hours)59.0556.5–66.9100.0984.8–139<0.001
 Total docetaxel (hours)38.0335.8–41.6100.0984.8–139<0.001
  • Abbreviation: RD, relative difference.

  • aRelative difference of CPC634 compared with conventional docetaxel.