4. Patients must have adequate renal and hepatic function: -- Total bilirubin </=1.5 x upper limit of normal (ULN) or </=3 x ULN for patients with Gilbert's disease (In pts with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin </= 1.5 x ULN are eligible), -- Creatinine clearance >50 mL/min (calculated according to institutional standards or using Cockcroft-Gault , MDRD, or CKD-EPI formula), -- alanine aminotransferase (ALT) and alanine aminotransferase (AST) </=3.0 x ULN, unless clearly due to disease involvement