NCT00262990已完成3 期
A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 829
- 试验地点
- 96
- 主要终点
- To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.
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
- •18 years of age or older
- •Confirmed diagnosis of ovarian, fallopian or peritoneal cancer
- •No more than three chemotherapy regimens
- •Most recent regimen must have been platinum based
排除标准
- •Have an unresolved bowel obstruction
- •Have had previous chemotherapy within 3 weeks
- •Recovering from any surgery for any cause
- •Other protocol-defined inclusion/exclusion criteria will apply.
研究组 & 干预措施
Patupilone
Experimental
干预措施: EPO906 (Patupilone) (Drug)
doxorubicin
Active Comparator
干预措施: doxorubicin (Drug)
结局指标
主要结局
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
时间窗: every 8 weeks
次要结局
- To investigate the safety and tolerability of patupilone(end of study)
- To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)(End of study)
- To determine the progression-free survival (PFS) of patients treated with patupilone(end of study)
- To determine the time to disease progression (TTP) of patients treated with patupilone(end of study)
- To determine overall best tumor response (CR, PR, SD, PD and Unknown)(end of study)
- To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events(end of study)
- To evaluate the pharmacokinetics (PK) of patupilone from all patients(end of study)
研究者
研究点 (96)
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