NCT00102973已完成3 期
Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]
Telik171 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 171
- 主要终点
- Study Objectives
研究概览
简要总结
The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Are a woman 18 years of age or older
- •Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer
- •Have platinum refractory or resistant cancer
- •Measurable disease according to radiographic RECIST criteria with documented tumor progression
排除标准
- •Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)
- •Have clinically significant cardiac disease
- •Have any sign of intestinal obstruction interfering with nutrition at the time of study entry
- •Are pregnant or lactating
- •Had prior treatment with liposomal doxorubicin for ovarian cancer
- •Had prior treatment with TLK286
研究组 & 干预措施
TLK286 in Combination with Carboplatin
Experimental
干预措施: TLK286 in Combination with Carboplatin (Drug)
Doxorubisin HCl Liposome Injection
Active Comparator
干预措施: Doxorubicin HCl Liposome Injection (Drug)
结局指标
主要结局
Study Objectives
时间窗: Every 8 Weeks
To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin
次要结局
未报告次要终点
研究者
研究点 (171)
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进行中（未招募）
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Phase 3 randomized study of TLK286 (Telcyta™) in combination with liposomal doxorubicin (Doxil®/Caelyx®) versus liposomal doxorubicin (Doxil®/Caelyx®) as second-line therapy in platinum refractory or resistant ovarian cancer - ASSIST-5EUCTR2006-000366-36-GBTelik, Inc.244