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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


Phase 2
18 Years
N/A
Not Enrolling
Male
CRPC, Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC

Outcome Description:

Number of patients with a progression-free survival of 6 months

Outcome Time Frame:

Patients will be followed for the duration of treatment, an expected average of 24 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

BIND-014-004

NCT ID:

NCT01812746

Start Date:

April 2013

Completion Date:

December 2015

Related Keywords:

  • CRPC
  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Albany, New York  12208