Prostate Cancer Clinical Trial
Official title:
A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer
The primary objectives of this study are the following:
Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with
mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of
the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard
ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant
prostate cancer (CRPC)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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