Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 36
- 主要终点
- Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
研究概览
简要总结
This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues.
详细描述
This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. There are indications of advantages in combining vascular disrupting agents with standard agents in the treatment of advanced non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male and females ≥ 18 years of age
- •ECOG performance status ≤ 1
- •Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial
- •All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2
- •Signed informed consent
排除标准
- •Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames
- •Significant cardiac history
- •Prior treatment with tumor vascular disruptive agents
- •Seizure disorder
- •Brain metastases
- •Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
- •Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C
- •Patients with a prior hypersensitivity reaction to product components
- •Pregnant or breast-feeding women.
- •Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •Unwilling or unable to comply with procedures required in this protocol
研究组 & 干预措施
docetaxel
docetaxel (75 mg/m2)
干预措施: docetaxel (Drug)
NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
干预措施: NPI-2358 + docetaxel (Drug)
结局指标
主要结局
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
时间窗: Continuous
次要结局
- Compare response rate, duration of response, 6-month survival, progression free survival and safety.(Continuous)
- Pharmacokinetics(Continuous)