NCT00080080已完成2 期
Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
Point Therapeutics19 个研究点 分布在 1 个国家开始时间: 2004年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 19
研究概览
简要总结
The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.
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
- •Histologically or cytologically confirmed Stage IIIb/IV NSCLC
- •Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
- •Measurable disease
- •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
- •Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
- •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
- •The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy
- •A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80
- •A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction <30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia
- •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 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
- •Pregnant or lactating women.
- •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; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes <1500/μL or platelets <100,000/μL.
研究者
研究点 (19)
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