- Patient has adequate organ function defined as a bilirubin within the normal range; AST < 1.5 times the upper limit of normal (ULN; < 2.5 times the ULN with liver involvement); alkaline phosphatase < 1.5 times ULN (< 3 times the ULN with liver involvement, or < 5 times the ULN with bone but no liver involvement); and serum creatinine < 2.0 mg/dL.