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

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