NCT00431275已完成1 期
An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: maximum plasma concentration of CP-675,206
研究概览
简要总结
This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Stage III or Stage IV melanoma
- •No evidence of disease following resection of melanoma lesions
- •Recovered from all prior surgical or adjuvant treatment-related toxicities
排除标准
- •History of chronic inflammatory or autoimmune disease
- •History of inflammatory bowel disease
研究组 & 干预措施
Current Formulation
Experimental
Current Formulation
干预措施: CP-675,206 (Drug)
Commercial Formulation
Experimental
Commercial Formulation
干预措施: CP-675,206 (Drug)
结局指标
主要结局
Pharmacokinetics: maximum plasma concentration of CP-675,206
时间窗: 1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve
时间窗: Time 0 to Day 85
次要结局
- Human-anti-human antibodies(1 year)
- Adverse events(1 year)
- Safety laboratory tests(1 year)
- Proportion of patients alive and free of disease at 1 year(1 year)
研究者
研究点 (1)
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