NCT00785941已完成1 期
Phase I Study of Anti-Insulin-Like Growth Factor-I Receptor (IGF-IR) Monoclonal Antibody IMC-A12 Administered Every Other Week in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom No Standard Therapy is Available
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to determine if IMC-A12 is safe for patients, and also to determine the best dose of IMC-A12 to give to patients.
详细描述
The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-IGF-IR monoclonal antibody IMC-A12 administered every other week in patients with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: 8 weeks
Maximum Tolerated Dose
时间窗: 8 weeks
次要结局
- Half-life (t 1/2), cohorts 1, 2, 3, 4, and 5(8 weeks)
- Maximum concentration (Cmax), cohorts 1, 2, 3, 4, and 5(8 weeks)
- Minimum concentration (Cmin), cohorts 1, 2, 3, 4, and 5(8 weeks)
- Area under concentration (AUC), cohorts 1, 2, 3, 4, and 5(8 weeks)
- Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, and 5(8 weeks)
- Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, and 5(8 weeks)
- Serum Anti-IMC-A12 Antibody Assessment (immunogenicity)(8 weeks)
- Change in tumor size from Baseline Measurement(8 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study of IMC-A12 in Participants With Tumors Who No Longer Respond to Treatment or For Whom No Treatment is AvailableAdvanced Solid TumorsNCT00785538Eli Lilly and Company24
已完成
1 期
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in AdolescentsAnorexia NervosaNCT00516386Massachusetts General Hospital16
撤回
1 期
A Phase I Study of IMC-A12 in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid TumorsBrain Stem NeoplasmsGliomaPinealomaNCT01182883National Cancer Institute (NCI)
已完成
1 期
IMC-A12 in Treating Young Patients With Relapsed or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor or Other Solid TumorRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorUnspecified Childhood Solid Tumor, Protocol SpecificNCT00609141National Cancer Institute (NCI)34
已完成
1 期
INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid TumorsUnresectable or Metastatic Solid TumorsNCT03589651Incyte Corporation83