Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< . x ULN; for patients with hepatic metastases, ALT and AST =< . x ULN are acceptable\r\n* Note: if a patient experiences elevated ALT > x ULN and elevated total bilirubin > x ULN, clinical and laboratory monitoring should be initiated by the investigator; for patients entering the study with ALT > x ULN, monitoring should be triggered at ALT > x baseline ALT ? x ULN Prior ALT- Subjects with ALT > x ULN at day are not eligible for enrollment ALT =< x ULN (. x ULN if considered to be due to leukemic involvement) ALT < . x ULN ALT > x ULN ALT (GPT) ? IU/L ALT x ULN at screening. Prior ALT- ALT > . x ULN ALT ? . x ULN