CRPC, Prostate Cancer
Conditions
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).
Interventions
DRUGBIND-014
Sponsors
BIND Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed