 - Adequate liver function as evidenced by bilirubin 1.5×ULN and alkaline phosphatase ALP, alanine aminotransferase ALT, and aspartate aminotransferase AST 3×ULN in the case of liver metastases 5×ULN. In case ALP is 3×ULN in the absence of liver metastases or 5×ULN in the presence of liver metastases AND the participant 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. 