Table 1.

NCI ODWG Liver Function Classification and Dosing Schema

Group	Group A Normal liver function	Group B Mild liver dysfunction	Group C Moderate liver dysfunction	Group D Severe liver dysfunction
Total Bilirubin (> 35% direct)	≤ ULN1	B1: ≤ ULN B2: >1.0x –1.5x ULN	>1.5x – 3x ULN	>3x ULN
ALT2	≤ ULN	B1: > ULN B2: Any	Any	Any
Dose Level	(mg/day)	(mg/day)	(mg/day)	(mg/day)
Level 1	800 (n=23)	400 (n=9)	200 (n=13)	100 (n=13)
Level 2		800 (n=14)	400 (n=7)	200 (n=19)
Level 3			800	400
Level 4				800

¹ULN = upper limit of normal

²ALT = alanine aminotransferase