 10. 9. continued 3 Hepatic: Serum total bilirubin 1.5 X ULN OR Direct bilirubin ULN for subjects with total bilirubin levels 1.5 ULN; AST SGOT and ALT SGPT 2.5 X ULN OR 5 X ULN for subjects with liver metastases. 4 Coagulation: International Normalized Ratio INR or Prothrombin Time PT 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin Time aPTT 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. 