A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer

A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer

The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable
• Hormone refractory prostate cancer defined as progressive based by documented 2 increase Prostate specific antigen (PSA) values over a previous reference value.
• Eastern Cooperative Oncology Group (ECOG) status 0-2
• Adequate hematological functions, liver and renal functions

Exclusion Criteria:

• Known hypersensitivity to docetaxel or taxane therapy
• Documented central nervous system or leptomeningeal metastasis at time of study entry
• Had prior treatment with chemotherapy, bone-seeking radionuclides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.
• Evidence of painful and/or destructive bone metastases for which radiation therapy, bisphosphonates or bone-seeking radionuclides are necessary.
• Have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.