EUCTR2006-004963-68-GR进行中（未招募）不适用
A Phase II, Open-Label Trial of Bortezomib (Velcade®) in Combination with Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Prof Vassilis Georgoulias0 个研究点目标入组 50 人开始时间: 2007年5月14日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •Patients with locally advanced Stage III? (not amenable to curative treatment) or metastatic (Stage IV) NSCLC who have not received prior systemic anti-neoplastic therapy (one additional prior line is allowed if given as neo-adjuvant or adjuvant therapy to tumor resection) will be enrolled in the study. The patient population comprises of men or women, 18 years of age or older. NSCLC must be histologically or cytologically confirmed. Additional inclusion criteria include: measurable disease per RECIST criteria and ECOG performance status score of 0 to 1.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria for this study include: presence of peripheral neuropathy of Grade 2 or greater intensity; significant weight loss (documented =10% body weight in the 6 weeks before randomization); inadequate organ function at the screening visit as defined in the protocol; cardiac disease as defined in the protocol;; active systemic infection requiring treatment; active second malignancy.
研究者
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