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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

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).

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Detailed Description

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Conditions

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CRPC Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIND-014

Group Type EXPERIMENTAL

BIND-014

Intervention Type DRUG

Interventions

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BIND-014

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No