AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

Inclusion criteria

• Pathologically confirmed adenocarcinoma of the prostate
• Radiographic evidence of metastatic disease
• Progressive disease meeting at least one of the following criteria:

• a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart with a 2 ng/mL minimum starting value, or
• progression according to RECIST criteria for measurable lesions, or
• appearance of 2 or more new lesions on bone scan.
• History of prior taxane-based chemotherapy for metastatic prostate cancer
• For patients without a history of surgical castration, continued GnRH analog administration is required
• ECOG Performance status of 0 or 1
• Life expectancy ≥ 3 months

Exclusion criteria

• Treatment with external beam radiotherapy ≤ 14 days before enrollment or radiopharmaceutical ≤8 weeks
• ≤ 4 weeks since receipt of most recent prior chemotherapy, non-GnRH analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and <6 weeks since receipt of prior bevacizumab.
• Known CNS metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area).
• Significant cardiovascular disease
• LVEF < 50% by MUGA or ECHO
• Treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection)
• Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed
• Major surgical procedure ≤30 days before enrollment or not yet recovered from prior major surgery
• Presence of peripheral edema > Grade 2
• Known positive test for HIV, hepatitis C, chronic or active hepatitis B
• Serious or non-healing wound
• Unable to begin protocol specified treatment within 7 days after enrollment
• Other investigational procedures are excluded.