NCT00586495已完成2 期
Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 95
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).
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
- 否
入选标准
- •Patients are classified into two groups as below at transition date from Study 11515 to this study.
- •Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study
- •Population II: Patients who have been monitored only for survival status at the end of Study
- •Population 1
- •Patients who are willing to continue the study drug,
- •Patients for whom the investigator consider continuation of the study drug is appropriate
- •Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study
- •Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- •Population 2
- •Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
排除标准
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- •Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
- •Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006)
Experimental
Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Time from initiation of treatment to disease progression (radiological or clinical, whichever earlier) or death (if death occurs before progression).
次要结局
- Best Tumor Response(From start of treatment of the first subject until 45 months later, assessed every 8 weeks)
- Overall Survival (OS)(From start of treatment of the first subject until 45 months later, assessed every 3 months)
- Overall Response Duration(From start of treatment of the first subject until 45 months later, assessed every 8 weeks)
- Time to Objective Response(From start of treatment of the first subject until 45 months later, assessed every 8 weeks)
- Overall Disease Control(From start of treatment of the first subject until 45 months later, assessed every 8 weeks)
研究者
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