NCT00858572已完成1 期
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies
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
- 31
- 主要终点
- To assess preliminary evidence of anti-neoplastic activity
研究概览
简要总结
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
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
Cohort
Experimental
干预措施: STA-9090 (ganetespib) (Drug)
结局指标
主要结局
To assess preliminary evidence of anti-neoplastic activity
时间窗: Feb 2011
To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
时间窗: Feb 2011
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
时间窗: Feb 2011
次要结局
- To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters(Feb 2011)
- To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)(Feb 2011)
- To assess changes in biomarkers following study drug administration(Feb 2011)
研究者
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