- The subject's serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT]), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory normal limit. Other biochemistry, hematology, and urinalysis laboratory parameters must not exceed National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.