A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 5
- 主要终点
- Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate
研究概览
简要总结
This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab
详细描述
This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 76 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
Step 1 Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel
干预措施: RAD001 (Drug)
Step 1, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel
干预措施: RAD001 (Drug)
Step 2, Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab
干预措施: RAD001 (Drug)
Step 2, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab
干预措施: RAD001 (Drug)
结局指标
主要结局
Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate
时间窗: Ever 3 months or once a critical DLT occurs
次要结局
- Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)(End of step 1)
- Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)(End of Step 2)
- PK parameters derived from PK profiles of treatment drugs alone and in combination(End of Step 1 and Step 2)
- Best overall response - measured by CT/MRI scan every 6-8 week(Every 6-8 week)