Evaluation of Safety and Feasibility of OGX-011 in Combination With 2nd-line Chemotherapy in Patients With HRPC

This study was initiated as a multicenter, open-label, randomized study, with a planned enrollment of 40 subjects. Although two treatment arms were included in this study, no comparison between the arms was intended. Subjects with metastatic HRPC who failed first-line docetaxel therapy and required second-line therapy were randomly assigned to treatment with OGX-011 in combination with docetaxel/prednisone (OGX-011/docetaxel/prednisone) or OGX-011 in combination with mitoxantrone/prednisone (OGX-011/mitoxantrone/ prednisone). The study was randomized to assure that subjects were enrolled in each of the two treatment arms in an unbiased manner. Based on preliminary safety data from the first 44 subjects who were randomized to receive either docetaxel or mitoxantrone, the protocol was amended to enroll approximately 20 additional subjects who would be assigned to the docetaxel/prednisone treatment arm to further investigate safety of the combination.