Multiple Ascending Dose (MAD) Phase Ib/II Study of the mTOR Inhibitor (RAD001) in Combination With the IGF-1R Antagonist (R1507) for the Treatment of Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 主要终点
- Progression-free survival (Part 2)
研究概览
简要总结
This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •histologically confirmed recurrent or refractory advanced solid tumor (Part 1);
- •advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);
- •measurable disease (Part 2);
- •ECOG performance status 0-2.
排除标准
- •prior treatment with agents acting via inhibition of IGF-IR pathway;
- •prior treatment with agents acting via inhibition of mTOR (Part 2);
- •untreated CNS metastases;
- •current anti-cancer therapy, or radiotherapy or chemotherapy <=4 weeks prior to enrollment;
- •other known malignancy requiring treatment.
研究组 & 干预措施
1
干预措施: RAD001 (Drug)
1
干预措施: RG1507 (Drug)
结局指标
主要结局
Progression-free survival (Part 2)
时间窗: 24 weeks
Maximum tolerated dose of RAD001, in combination with R1507 (Part 1
时间窗: First 3 week cycle of treatment
次要结局
- Overall objective response rate; duration of response; overall survival(Event driven; monitored throughout study)