NCT00035165已完成2 期
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- Tumor response (complete response (CR), partial response (PR), stable disease (SD))
研究概览
简要总结
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EPO906
Experimental
干预措施: epothilone b (Drug)
结局指标
主要结局
Tumor response (complete response (CR), partial response (PR), stable disease (SD))
时间窗: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)
Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.
次要结局
- Number and percentage of patients with Adverse events(as necessary)
- Objective response rate (ORR)(at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle))
- Time to disease progression (TTP)(at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle))
- Overall Survival (OS)(from the date of the first dose of treatment to date of death from any cause, or the last date the patient is known to be alive)
- Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma(prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment)
研究者
研究点 (6)
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