 4. Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal ULN and alkaline phosphatase ALP, alanine aminotransferase ALT, and aspartate aminotransferase AST less than or equal to 3 x ULN in the case of liver metastases less than or equal to 5 x ULN. In case ALP is greater than 3 x ULN in absence of liver metastases or greater than 5 x ULN in presence of liver metastases AND subject also is known to have bone metastases, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP. 