NCT00111020已完成3 期
Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,567
- 主要终点
- Safety parameters
研究概览
简要总结
This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced (unresectable, recurrent or metastatic) RCC
- •Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
- •Patients with an ECOG performance status of 0-2
- •Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
- •Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice
排除标准
- •Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
- •Patients who have participated in any other sorafenib trial
- •Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
- •Life expectancy of less than two months
- •Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
- •Patients with active coronary artery disease or ischemia
- •Patients with Child-Pugh class C hepatic impairment
- •Patients with severe renal impairment or who require dialysis
- •Patients with active uncontrolled hypertension
- •Patients with recent or active bleeding diathesis
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Safety parameters
时间窗: From signing consent to 30 days after last dose of study drug
次要结局
- Limited radiological evaluations(At baseline, than every 8 weeks after start of sorafenib)
研究者
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