NCT01812746已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety BIND-014 in patients with metastatic castration-resistant prostate cancer (mCRPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BIND-014
Experimental
干预措施: BIND-014 (Drug)
结局指标
主要结局
To determine the efficacy of BIND-014 as measured by radiographic progression-free survival (rPFS) in patients with chemotherapy-naïve metastatic CRPC
时间窗: 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
次要结局
- To assess the safety and tolerability of BIND-014(Patients will be followed for the duration of treatment, an expected average of 24 weeks)
研究者
研究点 (8)
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