NCT00057720已完成3 期
Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]
Telik579 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2003年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 579
研究概览
简要总结
The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Considered platinum refractory or resistant according to standard criteria
- •Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin
- •Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
- •Measurable disease according to RECIST criteria with documented tumor progression
排除标准
- •Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin
- •History of whole pelvis radiation therapy within 12 months of enrollment
- •Clinically significant cardiac disease
- •Evidence of gross hematuria at the time of study entry
- •Any signs of intestinal obstruction interfering with nutrition at the time of study entry
- •Pregnant or lactating women
研究者
研究点 (579)
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