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
- Registration Number
- NCT01812746
- Lead Sponsor
- BIND Therapeutics
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BIND-014 BIND-014 -
- Primary Outcome Measures
Name Time Method To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC Patients will be followed for the duration of treatment, an expected average of 24 weeks Number of patients with a progression-free survival of 6 months
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of BIND-014 Patients will be followed for the duration of treatment, an expected average of 24 weeks Number of patients who experience adverse events
Trial Locations
- Locations (8)
Investigative Site #16
🇺🇸Los Angeles, California, United States
Investigative Site #14
🇺🇸San Francisco, California, United States
Investigative Site #17
🇺🇸Fort Meyers, Florida, United States
Investigational Site #12
🇺🇸Ann Arbor, Michigan, United States
Investigational Site #11
🇺🇸New York, New York, United States
Investigational Site #15
🇺🇸Chapel Hill, North Carolina, United States
Investigational Site #13
🇺🇸Cleveland, Ohio, United States
Investigational Site #18
🇺🇸Nashville, Tennessee, United States
Investigative Site #16🇺🇸Los Angeles, California, United States