Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

Inclusion Criteria

• •Patient has hormone-refractory prostate cancer (HRPC) as evidenced by PSA progression or progression of measurable disease.
• •Patient has greater than 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week apart.
• •Patients on androgen deprivation treatment and will continue on androgen deprivation treatment during study participation except for patients who are post orchiectomy.
• •Patient has evidence of metastatic disease by positive bone scan or evidence of progressive metastatic disease by CT scan.
• •Patient has been treated with at least 1 prior hormone therapy or is post orchiectomy.
• •Patient has been previously treated at a minimum for an 8-week treatment period on a docetaxel-based regimen for metastatic HRPC.
• •Patient has PSA at least 5 ng/mL or greater.
• •Patient has testosterone less than 50 ng/dL.
• •Patient ECOG performance status of 0 or 1.
• •Patient has life expectancy of greater than 8 weeks.
• •Patient meets lab values: A. Absolute neutrophil count at least 1,500/mm\^3 or greater; B.Platelet count at least 100,000/mm\^3 or greater; C. Serum creatinine at least 1.5 mg/dL or less or creatinine clearance at least 60 mL/min or greater; D. Bilirubin less than 2.0 mg/dL. E. AST and ALT less or equal to 2.5 times upper limit of normal
• •Any chemotherapy, major surgery, or irradiation must be completed at least 4 weeks prior to study drug.
• •Patient recovered from clinically significant toxicities from prior treatment.