- Hepatic impairment, defined as bilirubin > 1.5 x institutional upper limit of normal (ULN) Patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome) are eligible or AST (SGOT), or ALT (SGPT), or alkaline phosphatase ≥ to 2 x ULN, within 21 days of initiation of protocol therapy.