NCT01792479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) as Second-line Therapy to Patients With Non-Small Cell Lung 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
- 64
- 试验地点
- 17
- 主要终点
- Number of patients with either a complete or partial response
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females at least 18 years of age
- •Diagnosis of NSCLC with locally advanced or metastatic disease
- •Previously treated with one platinum-based chemotherapy
- •Disease status must be that of measurable and/or evaluable disease
- •Performance status of 0 to 1 on the ECOG Scale
- •Prior chemotherapy completed at least 3 weeks prior to study enrollment
- •Prior radiation therapy allowed to < 25% of the bone marrow
- •Patient compliance and geographic proximity that allow adequate follow-up
- •Adequate organ function
- •Patients with reproductive potential must use contraceptive methods
- •Signed informed consent from patient
排除标准
- •Active infection
- •Pregnancy or planning to become pregnant
- •Breast feeding
- •Serious concomitant systemic disorders
- •Second primary malignancy
- •Patients who are symptomatic from brain metastasis
- •Presence of detectable (by physical exam) third-space fluid collections
- •More than 1 prior cytotoxic chemotherapy regimen for advanced disease
- •Prior treatment with docetaxel
- •History of severe hypersensitivity reaction to polysorbate 80
- •Peripheral neuropathy at study entry
- •Patients known to be HIV positive
- •Patients known to be seropositive for hepatitis C hepatitis B
- •Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
研究组 & 干预措施
Arm A: BIND-014 every 3 weeks
Experimental
干预措施: BIND-014 (Drug)
Arm B: BIND-014 weekly
Experimental
干预措施: BIND-014 (Drug)
结局指标
主要结局
Number of patients with either a complete or partial response
时间窗: Patients will be followed for the duration of treatment, an expected average of 18 weeks
To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease.
次要结局
- Number of patients who experience adverse events(Patients will be followed for the duration of treatment, an expected average of 18 weeks)
研究者
研究点 (17)
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