NCT00243204终止3 期
Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy
Point Therapeutics186 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 186
研究概览
简要总结
This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.
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
- Double
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
- •Men or women age 18 years or older
- •Histologically or cytologically confirmed NSCLC
- •Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)
- •Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion
- •Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
- •Measurable disease on computerized tomography (CT) scan
- •ECOG Performance Status of 0 or 1
- •Expected survival ≥12 weeks
- •Provide written informed consent
排除标准
- •More than 2 prior chemotherapy regimens
- •Clinically significant laboratory abnormalities, specifically:
- •Total bilirubin ≥ institutional upper limit of normal (ULN)
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN
- •Serum creatinine ≥2.0mg/dL
- •Absolute neutrophil count <1500/μL or platelets <100,000/μL
- •Untreated or symptomatic brain metastases
- •Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- •A history of severe hypersensitivity to drugs formulated with polysorbate 80
- •Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- •Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.
- •Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.
研究者
研究点 (186)
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