NCT00106301已完成2 期
A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228
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
- Celgene
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of extended treatment with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228 clinical trials.
详细描述
This is a Phase II, non-randomized, open-label, single arm, continuation trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial;
- •Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial;
- •Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Fujisawa-sponsored FK228 clinical trial.
排除标准
- •Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy
研究组 & 干预措施
FK228 (romidepsin)
Experimental
romidepsin
干预措施: FK228 (romidepsin) (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 6 months
次要结局
- To evaluate the time to objective disease progression.(Up to 6 months)
- To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment(Up to 6 months)
研究者
研究点 (5)
Loading locations...
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