Status:
COMPLETED
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
Lead Sponsor:
BIND Therapeutics
Conditions:
CRPC
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01812746
Start Date
April 1 2013
End Date
April 1 2016
Last Update
April 15 2016
Active Locations (8)
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1
Investigative Site #16
Los Angeles, California, United States, 90048
2
Investigative Site #14
San Francisco, California, United States, 94115
3
Investigative Site #17
Fort Meyers, Florida, United States, 33908
4
Investigational Site #12
Ann Arbor, Michigan, United States, 48109