A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Pediatric Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- Dalotuzumab mean serum trough concentration in combination therapy
研究概览
简要总结
This is a study of dalotuzumab given as monotherapy and in combination with ridaforolimus for pediatric participants with advanced solid tumors. This study will have three parts. Part 1 will find a maximum tolerated dose (MTD) and collect pharmacokinetic (PK) data for dalotuzumab alone. Part 2 will find an MTD and collect PK data for dalotuzumab in combination with ridaforolimus. Part 3 will be an expansion cohort at the recommended Phase 2 dose (RPTD) found in Part 2 to confirm the RPTD and look at the potential efficacy of the combination therapy.
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
- 3 Years 至 17 Years（Child）
- 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
Part 1: Dalotuzumab
干预措施: dalotuzumab (Drug)
Parts 2 and 3: Dalotuzumab + ridaforolimus
干预措施: dalotuzumab (Drug)
Parts 2 and 3: Dalotuzumab + ridaforolimus
干预措施: ridaforolimus (Drug)
结局指标
主要结局
Dalotuzumab mean serum trough concentration in combination therapy
时间窗: Day 22, pre-dose (Part 2)
Number of participants with DLTs while receiving dalotuzumab and ridaforolimus combination therapy
时间窗: First 21 days of treatment
Dalotuzumab mean serum trough concentration
时间窗: Day 22, pre-dose (Part 1)
Number of participants with dose limiting toxicities (DLTs) while receiving dalotuzumab alone
时间窗: First 21 days of treatment
Ridaforolimus geometric mean area under the concentration curve from Hour 0 to Hour 24 (AUC [0-24]) in combination therapy
时间窗: Cycle 1, Day 5 (Part 2)
次要结局
未报告次要终点