Phase II Multi-Center Trial of Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 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
Olaparib + Trabectedin
There are 2 cohorts. Both cohorts receive the same treatment:
- Cohort 1: Leiomyosarcoma and liposarcoma
- Cohort 2: Other bone or soft tissue sarcoma histologies
Treatment consists of 21-day cycles for a maximum of 18 months.
干预措施: Trabectedin (Drug)
Olaparib + Trabectedin
There are 2 cohorts. Both cohorts receive the same treatment:
- Cohort 1: Leiomyosarcoma and liposarcoma
- Cohort 2: Other bone or soft tissue sarcoma histologies
Treatment consists of 21-day cycles for a maximum of 18 months.
干预措施: Olaparib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 2 years
Percentage of participants with complete or partial response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, within each cohort.
次要结局
- Progression Free Survival(At 1 year after enrollment)
- Overall Survival(At 2 years after enrollment)
- Incidence of Adverse Events(Up to 30 days after end of treatment, and average of 4.5 months)