Table 5.

Mean (SD) pharmacokinetic variables of trabectedin, doxorubicin, and doxorubicinol in patients coadministered single doses of trabectedin and doxorubicin

VariableTrabectedin
Doxorubicin
Doxorubicinol
Level 1 (n = 3)Level 2 (n = 5)Level 3 (n = 5)Level 1 (n = 3)Level 2 (n = 5)Level 3 (n = 5)Level 1 (n = 3)Level 2 (n = 5)Level 3 (n = 5)
Cmax, ng/mL5.97 (0.92)8.44 (2.74)8.91 (3.38)1750 (453)*2452 (286)3596 (1972)20.1 (3.17)25.4 (8.96)31.1 (13.5)
tmax, h2.75 (2.72-2.83)1.00 (0.92-2.87)2.83 (0.92-2.97)0.25 (0.25-0.25)*0.25 (0.20-0.30)0.25 (0.17-0.33)1.25 (0.25-5.42)1.25 (0.28-3.00)1.27 (0.17-1.45)
AUClast, ng h/mL32.7 (3.63)51.4 (14.5)59.9 (26.9)2000 (187)*2505 (88)3187 (1273)607 (58.2)680 (143)795 (262)
AUC8, ng h/mL36.3 (3.89)57.3 (12.5)72.2 (28.2)2406 (55.5)*2781 (111)3499 (1206)1548 (928)1373 (293)1566 (648)§
t½, h69.5 (17.7)85.4 (24.88)90.9 (17.8)29.2 (3.62)24.1 (2.30)27.2 (8.66)65.4 (44.6)53.6 (15.3)52.7 (12.6)§
λz, h−10.0105 (0.00286)0.00880 (0.00305)0.00786 (0.00158)0.0239 (0.00295)0.0290 (0.00293)0.0279 (0.00969)0.0137 (0.00701)0.0138 (0.00378)0.0136 (0.00304)§
CL, L/h42.0 (7.69)37.2 (9.10)37.4 (17.4)42.5 (6.86)*40.1 (5.12)33.5 (7.79)NRNRNR
Vss, L2,163 (197)2,574 (1,193)3,028 (1,811)956 (474)*561 (124)495 (318)NRNRNR
  • Abbreviation: NR, not reported.

  • * n = 2.

  • Median (range).

  • n = 4.

  • § n = 3.