CTRI/2010/091/000491已完成2 期
Phase 2 Randomized Study of Carboplatin / Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer
Daiichi Sankyo Pharma Development399 Thornall StreetEdison, NJUSA0 个研究点目标入组 115 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
- •2) Age greater than or equal to 18 years (<65 years in India)
- •3) Adequate organ and bone marrow function
- •4) Measurable disease based on RECIST criteria
- •5) ECOG performance status ≦ 1
排除标准
- •1) Any prior systemic therapy for NSCLC
- •2) Major surgical procedure or other investigational agents within 4 weeks before study enrollment
- •3) Need for concomitant use of other thiazolidinediones during the study
- •4) History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or TZDs agents; Myocardial infarction with significant impairment of cardiac function; severe unstable angina pectoris; coronary/peripheral artery bypass graft; NYHA class III or IV congestive hart failure; malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction
- •5) Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis
- •6) Periocardial or pleural effusion (e.g. requiring drainage) or pericardial involvement with the tumor
研究者
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