Rechallenge With PLD Added to Trabectedine in Recurrent Ovarian Cancer: a Multicenter Prospective Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL
详细描述
To demonstrate that rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) is active (objective response rate) in relapsed ovarian cancer patients who have already received pegylated liposomal doxorubicin and progress within 6-12 months after the end of last platinum or in fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments
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
Single Arm
PLD 30 mg/mq 1 h iv + Trabectedin 1.1 mg/mq 3 h iv d1q21 up to 6 cycles or PD.
干预措施: PLD and Trabectedin rechallenge (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 30 months
次要结局
未报告次要终点
研究者
SCAMBIA GIOVANNI
Associate Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS