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
- 9
- 主要终点
- Survival
研究概览
简要总结
The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.
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 who had participated in a previous sorafenib study that had completed, who did not meet withdrawal criteria of the previous study and who were, in the opinion of the investigator and sponsor still benefiting from treatment.
排除标准
- •The current cardiovascular situation of the patient was carefully re-evaluated by both the investigator and the sponsor and an informed decision as to inclusion was then made.- Substance abuse, medical, psychological or social conditions that may have interfered with the patient's participation in the study or evaluation of the study results.- Known or suspected allergy to the investigational agent.- Any condition that was unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Nexavar (Sorafenib, BAY43-9006) (Drug)
结局指标
主要结局
Survival
时间窗: Death
次要结局
- Objective Tumour Response Rate(Number of confirmed partial and complete responses)
- Overall Response Duration(Time from the date of the first intake of sorafenib to the date that progressive disease is documented.)
- Time to Objective Response(Time from the date of the first intake of sorafenib to the date that objective response is first documented.)
- Time to Disease Progression(Time from first intake of sorafenib to disease progression)
- Safety Parameters(Throughout study)
研究者
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