Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 129
- 主要终点
- Progression-Free Survival
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with pleural malignant mesothelioma that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the 4-month progression-free survival in patients with unresectable malignant pleural mesothelioma treated with everolimus.
Secondary
- To determine the response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in patients with measurable disease by RECIST and modified RECIST criteria.
- To determine overall survival of these patients.
- To evaluate the frequency and severity of toxicities associated with this treatment regimen.
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 120 Years（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
Daily oral Everolimus 10 mg/day
干预措施: everolimus (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Every 8 weeks until disease progression, up to 3 years.
Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a \>= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease
次要结局
- Response(Every 8 weeks until disease progression, up to 3 years.)
- Overall Survival(Every 8 weeks until disease progression, up to 3 years.)
- Frequency and Severity of Toxicities(Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.)