Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 90
- 主要终点
- Proportion of patients with progression-free disease at 16 weeks
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus.
Secondary
- Determine the median overall survival of patients treated with this drug.
- Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug.
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
- 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
everolimus
Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.
干预措施: everolimus (Drug)
结局指标
主要结局
Proportion of patients with progression-free disease at 16 weeks
时间窗: at 16 weeks
次要结局
- disease progression(at 16 weeks)
- Median overall survival(Up to 5 years)
- Toxicity as measured by CTCAE v. 3.0(Up to 5 years)
- Tumor response rate for 2 consecutive evaluations at least 8 weeks apart(Up to 5 years)