An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

A Phase I/II Multicenter, Open-Label Study of YM155 Plus Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

To determine the feasibility and safety of administering YM155 in combination with docetaxel

This clinical trial is designed to include two parts:

Part 1: Assessment of feasibility and safety of administering YM155 in combination with docetaxel and prednisone in subjects with hormone refractory prostate cancer (HRPC) [ ENROLLMENT COMPLETED ]

Part 2: Assessment of feasibility and safety of administering YM155 in combination with docetaxel in subjects with solid tumors (except HRPC).

This registration has been updated to reflect the design requirements of PART 2.

Inclusion Criteria:

Part 1:

• Male subjects with histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.

Part 2:

• Subjects with histologically and cytologically confirmed solid tumors with measurable disease (except HRPC).

Exclusion Criteria:

• Radiation therapy within 4 weeks of the start of study drug