6. Adequate liver function defined as: Alanine transaminase (ALT) </= 2.5 x upper normal limit (ULN) (</=5 x ULN for subjects with documented metastatic disease to the liver); Aspartate aminotransferase (AST) </= 2.5 x ULN (</=5 x ULN for subjects with documented metastatic disease to the liver); Alkaline phosphatase < 4 x ULN; Total Bilirubin </= 1.5 x ULN (In the expansion cohort, subjects with Gilbert's syndrome [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of </= 3 x ULN); Albumin >/=3 g/dL.