A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer

Inclusion Criteria

• The participant has histologically-confirmed adenocarcinoma of the prostate
• The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
• The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
• The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
• The participant must have evidence of progressive disease defined as at least one of the following;
• Progressive measurable disease: using conventional solid tumor criteria
• Bone scan progression: at least two new lesions on bone scan
• Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
• The participant has a PSA ≥ 2 ng/mL
• The participant has prior surgical or medical castration with a serum testosterone of 40 mL/min)
• The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
• The participant has known or suspected brain or leptomeningeal metastases
• The participant has uncontrolled or poorly controlled hypertension
• The participant has poorly controlled diabetes mellitus. Inclusion Criteria:
• The participant has histologically-confirmed adenocarcinoma of the prostate
• The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
• The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
• The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
• The participant must have evidence of progressive disease defined as at least one of the following;
• Progressive measurable disease: using conventional solid tumor criteria
• Bone scan progression: at least two new lesions on bone scan
• Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
• The participant has a PSA ≥ 2 ng/mL
• The participant has prior surgical or medical castration with a serum testosterone of 40 mL/min)
• The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
• The participant has known or suspected brain or leptomeningeal metastases
• The participant has uncontrolled or poorly controlled hypertension
• The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes are allowed