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Table 4 Trametinib pharmacokinetic parameters with trametinib dose normalized to 2 mg for PK evaluable patients (n = 22)

From: Phase I pharmacokinetic study of single agent trametinib in patients with advanced cancer and hepatic dysfunction

 

Descriptive

Statistics

Normal

Group Norm

(n = 10)

Mild

Group Mild

(n = 6)

Moderate

Group Mod

(n = 3)

Severe

Group Sev

(n = 3)

Cmax (ng/mL)

Geo mean (%CV)

Mean (±SD)

26.2 (31.4)

27.6 (±8.7)

26.2 (53.8)

29.5 (±15.9)

16.8 (12.6)

16.9 (±2.1)

15.3 (43.6)

16.3 (±7.1)

Cmin (ng/mL)

Geo mean (%CV)

Mean (±SD)

14.4 (29.8)

15.1 (±4.5)

10.8 (57.3)

12.1 (±7.0)

10.4 (22.4)

10.5 (±2.4)

7.6 (32.3)

7.9 (±2.5)

Cavg (ng/mL)

Geo mean (%CV)

Mean (±SD)

18.7 (28.1)

19.5 (±5.5)

14.7 (51.9)

16.2 (±8.4)

13.0 (8.1)

13.0 (±1.1)

9.5 (36.4)

10.0 (±3.6)

AUC0 − 24 (hr*ng/mL)

Geo mean (%CV)

Mean (±SD)

449.5 (28.1)

468.8 (±132.0)

352.1 (51.9)

387.7 (±201.3)

311.0 (8.1)

311.7 (±25.2)

228.9 (36.4)

239.5 (±87.1)

CLssF (mL/hr)

Geo mean (%CV)

Mean (±SD)

4449.0 (36.0)

4675.0 (±1683.6)

5680.0 (45.5)

6200.0 (±2818.6)

6431.6 (8.4)

6446.4(±542.6)

8736.3 (36.5)

9141.3 (±3337.1)

Albumin level (g/L)a

n = 24

Mean

(±SD)

33.9

(±3.1)

34.2

(±5.6)

33.2

(±4.6)

32.5

(±4.9)

  1. Abbreviations: Geo mean geometric mean; %CV coefficient of variation; mean arithmetic mean; SD standard deviation; n number of patients; Cmax maximum concentration; Cmin minimum concentration; Cavg average concentration; AUC0− 24 area under the plasma concentration–time curve 0-24 h; CLssF apparent oral clearance at steady state
  2. aSerum albumin level of patients with trametinib unbound PK blood sample (PK evaluable and non-evaluable) n = 24