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临床试验/NCT00047801
NCT00047801已完成1 期

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer

Telik8 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2002年10月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
28
试验地点
8

研究概览

简要总结

The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.

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

入选标准

  • Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma
  • Stage IV or Stage IIIB
  • Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen
  • At least 18 years of age
  • Good performance status (ECOG 0 to 1)
  • Adequate liver, renal, and bone marrow function

排除标准

  • Pregnant or lactating women
  • Treatment with more than one cytotoxic therapy
  • Prior radiation to the whole pelvis
  • Unstable medical conditions such as uncontrolled cardiac arrhythmia
  • Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80

研究者

发起方
Telik
申办方类型
Industry

研究点 (8)

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