NCT00414765已完成4 期
Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy
研究概览
简要总结
This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.
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
Aldesleukin
Experimental
All participants were treated with aldesleukin 600,000 international units per kilogram [IU/kg] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
干预措施: Aldesleukin (Drug)
结局指标
主要结局
Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy
时间窗: From Cycle 1, Day 1 to Cycle 2, Day 15
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Study of the Effect of Renal Impairment on the Pharmacokinetics of VepoloxamerPharmacokinetics of VepoloxamerHealthy VolunteersRenal ImpairedNCT02646358Mast Therapeutics, Inc.27
已完成
1 期
A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney FunctionOverweightObesityNCT04209049Novo Nordisk A/S33
已完成
1 期
Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy SubjectsRenal ImpairmentNCT02084199Galapagos NV24
已完成
1 期
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.Diabetes Mellitus Type 2NCT00368368Hoffmann-La Roche5
尚未招募
不适用
PK of intra-vaginal oxybutyniNL-OMON20539iGalli BV8