NCT00085527撤回2 期
A Phase II Study Of Depsipeptide In Patients With Relapsed Or Refractory Ovarian Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Response rate of depsipeptide in ovarian cancer
研究概览
简要总结
RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory advanced ovarian epithelial cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate (complete and partial) in patients with relapsed or refractory advanced ovarian epithelial carcinoma treated with FR901228 (depsipeptide).
- Determine the toxicity of this drug in these patients.
Secondary
- Correlate clinical response with platinum sensitivity in patients treated with this drug.
- Correlate clinical response with P-glycoprotein expression or p53 status in patients treated with this drug.
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
- Female
- 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
depsipeptide
Experimental
Depsipeptide administered on Days 1, 8, and15 of a 28-day cycle.
干预措施: depsipeptide (Drug)
结局指标
主要结局
Response rate of depsipeptide in ovarian cancer
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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