EUCTR2007-005941-39-FR进行中（未招募）1 期
An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung Cancer
aboratoires Merck Sharp & Dohme - Chibret0 个研究点目标入组 95 人开始时间: 2008年4月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age greater than or equal to 18 years
- •Histologically/cytologically documented, unresectable, locally advanced, recurrent or relapsed metastatic Stage IIIB/IV NSCLC
- •Measurable disease
- •ECOG performance status 0-2
- •Adequate hematologic, renal, and hepatic function: ANC greater than or equal to 1,500/µl, platelet greater than or equal to 100,000/ µl, Creatinine < 1,5 ULN; T.bilirubin = 1,5 ULN, AST/ALT = 2,5 ULN, etc.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Chemotherapy or therapeutic radiotherapy within 2 weeks or
- •biological therapy such as bevacizumab (Avastin) within 4 weeks, prior to entering the study is not allowed
- •Prior EGFR – TKI inhibitor/anti-EGFR mAb therapy is not allowed
- •Prior IGF1R - TKI inhibitor/anti-IGF1R mAb therapy is not allowed
- •No more than 2 prior systemic therapies
- •Patient who has not completed radiotherapy with complete resolution of toxicities at least 2 weeks prior to beginning this study.
研究者
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