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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BIND Therapeutics
• Treatments: Docetaxel

Criteria

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