NCT02283320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 a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell 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
- 69
- 试验地点
- 32
- 主要终点
- Disease control rate
研究概览
简要总结
BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.
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
- 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
- •Positive for KRAS mutation or Squamous cell histology
- •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
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Experimental
干预措施: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) (Drug)
结局指标
主要结局
Disease control rate
时间窗: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks
次要结局
- Overall survival(Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation)
- Progression-free survival(Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks.)
- Duration of response(Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks)
- Time to response(change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug)
- Disease control rate(Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks)
- Safety and tolerability, as measured by number of participants with adverse events.(Measured from first dose of study drug until 30 days after study discontinuation.)
- Objective response rate(change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks,)
研究者
研究点 (32)
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