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

An Open Label, Multicenter, 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

The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC).

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Metastatic disease progressing despite castrate levels of testosterone
• Prostate cancer progression documented by PSA
• Surgically or medically castrated, with testosterone levels of < 50 ng/dL
• Previous anti-androgen therapy and progression after withdrawal
• ECOG performance status of 0 to 1
• Adequate organ function
• Prior radiation therapy allowed to < 25% of the bone marrow
• Prior hormonal therapy is allowed
• Patient compliance and geographic proximity that allow adequate follow-up.
• Patients with reproductive potential must use contraceptive methods
• Signed informed consent from patient

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