NCT00110357已完成1 期
Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 9
- 主要终点
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan
研究概览
简要总结
The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of a solid tumor which has progressed on, or following standard therapy, or for which no standard effective therapy is known.
- •Children age 1-18 years.
排除标准
- •Presence of active infection.
- •Requirement to receive concurrent chemotherapy immunotherapy, radiotherapy, or any other investigational drug while on study.
- •Inadequate bone marrow, hepatic, or renal function.
研究组 & 干预措施
Group A
Active Comparator
1-12 years old
干预措施: Cetuximab + Irinotecan (Drug)
Group B
Active Comparator
13-18 years old
干预措施: Cetuximab + Irinotecan (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan
时间窗: Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.
MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2)
次要结局
- Clearance Corrected for Body Surface Area (CL/BSA)(up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study)
- Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)(up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study)
- Tumor Response(Every other 21-day cycle)
- Human Anti-cetuximab Antibody (HACA) Response(Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle)
- Number of Participants With a Dose-Limiting Toxicity(Prior to each 21-day cycle until dose-limiting toxicities)
- Area Under the Curve, Extrapolated to Infinity (AUC[INF])(up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study)
- Terminal Half-Life (T-Half)(up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study)
- Maximum Plasma Concentration (Cmax)(up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study)
- Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)(Weekly throughout the study and every 4 weeks thereafter)
- Grade 3-4 Laboratory Abnormalities - Leukopenia(pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment)
- Grade 3-4 Laboratory Abnormalities - Neutropenia(pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment)
- Grade 3-4 Laboratory Abnormalities - Thrombocytopenia(pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment)
- Grade 3/4 Laboratory Abnormalities - Hypomagnesemia(pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment)
研究者
研究点 (9)
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