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Table 2 Carfilzomib PK parameters and inferential PK statistics comparing carfilzomib exposure following IV administration of carfilzomib (PK-evaluable population)

From: Pharmacokinetics of carfilzomib in patients with advanced malignancies and varying degrees of hepatic impairment: an open-label, single-arm, phase 1 study

PK parameters

27 mg/m2 by hepatic function

56 mg/m2 by hepatic function

Normal

(n = 10)

Mild impairment

(n = 14)

Moderate

impairment

(n = 9)

Normal

(n = 8)

Mild impairment

(n = 8)

Moderate

impairment

(n = 5)

AUC0–last, ng·hr/mL

378 (40.8)

546 (39.2)

477 (33.1)

765 (100.5)

1107 (73.7)

927 (45.8)

AUC0–inf, ng·hr/mL

348 (35.4)a

529 (40.3)b

500 (38.4)c

609 (99.6)d

1108 (73.7)

929 (46.2)

Cmax, ng/mL

932 (58.4)

1290 (47.5)

1020 (43.7)

1697 (93.7)

2733 (67.0)

2119 (47.9)

Tmax, h

0.292 (0.250–0.500)

0.458 (0.250–0.667)

0.483 (0.233–0.750)

0.300 (0.250–0.583)

0.408 (0.250–0.683)

0.400 (0.250–0.583)

T1/2, h

0.469 (22.8)a

0.541 (75.9)b

0.511 (219.4)c

0.508 (54.7)d

0.621 (47.7)

0.740 (137.7)

  1. Values presented as geometric mean (geometric CV%); Tmax median (minimum–maximum is presented). Data in table excludes n = 1 cycle 2 day 1 outlier patient from the normal hepatic function group
  2. AUC 0–inf area under the concentration time curve from time extrapolated to infinity, AUC 0–last area under the concentration time curve from time 0 to last concentration measurement, C max maximum plasma concentration, T max time to maximum plasma concentration
  3. an = 8
  4. bn = 12
  5. cn = 7
  6. dn = 6