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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BIND Therapeutics
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
