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

Phase 2

Completed

• Conditions: CRPC; Prostate Cancer
• Interventions: Drug: BIND-014

• 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

Study Timeline

• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-18
• Study Start: 2013-04
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

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)

Investigational Site #11; 🇺🇸 New York, New York, United States

Investigational Site #12; 🇺🇸 Ann Arbor, Michigan, United States

Investigative Site #17; 🇺🇸 Fort Meyers, Florida, United States

Investigational Site #13; 🇺🇸 Cleveland, Ohio, United States

Investigative Site #14; 🇺🇸 San Francisco, California, United States

Investigational Site #15; 🇺🇸 Chapel Hill, North Carolina, United States

Investigative Site #16; 🇺🇸 Los Angeles, California, United States

Investigational Site #18; 🇺🇸 Nashville, Tennessee, United States