NCT01830153已完成2 期
A Phase II Multicenter Trial of RAD001 in Patients With Metastatic or Recurrent Sarcomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- Progression-free survival rate at 16 weeks
研究概览
简要总结
This trial intends to test the efficacy and safety of RAD001 in patients with advanced sarcoma who failed to conventional chemotherapy.
详细描述
This multicenter, phase II trial evaluated the efficacy and safety of everolimus in patients with metastatic or recurrent bone and soft tissue sarcoma after failure of anthracycline and/or ifosfamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed metastatic, unresectable bone or soft tissue sarcomas who had past treatment with anthracycline and/or ifosfamide to which the disease was primarily refractory or progressed after initial response.
- •Any of above drugs is allowed to be used as adjuvant treatment.
- •Unidimensionally measurable disease
- •3 or less than prior chemotherapies
- •Age 17 years old or older
- •ECOG performance status 2 or less, Life expectancy 6 month or less
- •Adequate bone marrow, liver, kidney, and cardiac function
- •Written informed consent
排除标准
- •Pregnant or lactating patients
- •Patients with resectable metastasis
- •Patients with history of CNS metastasis
- •Gastrointestinal stromal tumors, chondrosarcoma, neuroblastoma
- •Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.
- •Any preexisting medical condition of sufficient severity to prevent full compliance with the study
研究组 & 干预措施
RAD001
Experimental
RAD001 was given as 10 mg orally once daily, and one cycle was defined as 28 days.
干预措施: RAD001 (Drug)
结局指标
主要结局
Progression-free survival rate at 16 weeks
时间窗: 16 weeks
Determined as the proportion of progression-free (complete response, partial response and stable disease) at 16 weeks of treatment
次要结局
- Progression-free survival(Up to 24 months)
- Overall survival(Up to 24 months)
- Response rate(Up to 24 months)
- Toxicity(Up to 24 months)
研究者
Jin-Hee Ahn
Professor
Asan Medical Center
研究点 (8)
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