A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients With Metastatic Castration-Resistant Prostate Cancer

Exclusion Criteria

• •Active infection
• •Any chronic medical condition requiring a high doses of corticosteroid
• •Pathological finding consistent with small cell carcinoma of the prostate
• •Brain metastasis
• •Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
• •Radiation therapy for treatment of the primary tumor within 6 weeks
• •Radionuclide therapy for treatment of metastatic CRPC
• •Prior systemic treatment with an azole drug
• •Prior flutamide treatment within 4 weeks
• •Prior bicalutamide or nilutamide within 6 weeks
• •Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
• •Administration of an investigational therapeutic within 2 weeks
• •Second primary malignancy
• •Presence of clinically detectable third-space fluid collections
• •History of severe hypersensitivity reaction to polysorbate 80
• •Peripheral neuropathy at study entry