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

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

Official Title
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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

Conditions
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CRPC, Prostate Cancer

Intervention / Treatment
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* Drug: BIND-014


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIND-014<br> | Drug: BIND-014<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC | Number of patients with a progression-free survival of 6 months | Patients will be followed for the duration of treatment, an expected average of 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of BIND-014 | Number of patients who experience adverse events | Patients will be followed for the duration of treatment, an expected average of 24 weeks |