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-5)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 244
- 试验地点
- 68
- 主要终点
- To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin
研究概览
简要总结
The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.
详细描述
This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).
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 or primary peritoneal cancer
- •Have platinum refractory or resistant cancer
- •Measurable disease according to radiographic RECIST criteria progression
排除标准
- •Had treatment with first-line chemotherapy other than a platinum-containing regimen
- •Have clinically significant cardiac disease
- •Have any sign of intestinal obstruction interfering with nutrition
- •Are pregnant or lactating
- •Had prior treatment with liposomal doxorubicin
- •Had prior treatment with Telcyta
研究组 & 干预措施
Telcyta + Liposomal Doxorubicin
Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
干预措施: Telcyta (Drug)
Telcyta + Liposomal Doxorubicin
Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
干预措施: Liposomal Doxorubicin (Drug)
Liposomal Doxorubicin
Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
干预措施: Liposomal Doxorubicin (Drug)
结局指标
主要结局
To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin
时间窗: Once 244 planned pts. received at least 2 cycles of study treatment(s)
次要结局
- To evaluate and compare the safety profile of each treatment arm(Any patient who received 1 dose of study treatment(s) will be evaluable for safety.)