BrUOG- Phase 1-233: A Phase I Study of Ridaforolimus With Cetuximab for Patients With Advanced Head and Neck Cancer, Non-Small Cell Lung Cancer and Colon Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab
研究概览
简要总结
The main purpose of this study is to evaluate the best dose, safety and side effects of ridaforolimus when given with cetuximab for patients with head and neck, lung and colon cancer that has progressed after initial therapy. A second purpose of this study is to gain preliminary information on whether the combination of ridaforolimus and cetuximab is helpful in treating patients with advanced head and neck cancer
详细描述
Patients with advanced NSCLC, colorectal cancer, and head and neck cancer that progressed after at least 1 prior regimen for metastatic disease were eligible. Wild-type K-ras was required in colon cancer. All patients received cetuximab 400 mg/m2 week 1 followed by 250 mg/m2/week. Four dose levels of ridaforolimus were planned: 10mg, 20mg, 30mg, and 40mg daily, 5 days each week, on a 28-day cycle.
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
Ridaforolimus
Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression
干预措施: Ridaforolimus (Drug)
结局指标
主要结局
Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab
时间窗: 1 year
the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day
次要结局
- Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus.(1 year)
研究者
Angela Taber MD
Principle Investigator
Brown University