NCT01183364已完成1 期
A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor 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
- 27
- 试验地点
- 1
- 主要终点
- Safety of STA-9090 (ganetespib) and docetaxel combination
研究概览
简要总结
This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor malignancies. The safety and tolerability of the treatment will also be evaluated.
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
- •Must have histologically confirmed metastatic or unresectable malignancy with evidence of progression
- •If subject has been treated with docetaxel, must have evidence of persistent or progressive disease
- •Measurable disease per RECIST
- •CNS metastases are permitted if treated and radiographically and clinically stable for 4 weeks prior to first dose
- •ECOG status less than or equal to 2
- •Life expectancy greater than 3 months
- •Adequate hematological, hepatic and renal function as defined by protocol
- •Willingness and ability to comply with study requirements
- •Female subjects of childbearing age must have a negative pregnancy test at study entry
- •Female subjects of child bearing age and males must agree to use adequate contraception as defined in the protocol
排除标准
- •Prior chemotherapy or investigational agents within 3 weeks or 5 times the agent's half life, whichever is shorter prior to first dose
- •Radiotherapy within 2 weeks of first dose
- •Surgery, radiotherapy or ablative procedure to the only area of measurable disease
- •Major surgery within 4 weeks of first dose
- •Poor venous access that would require an indwelling catheter for study drug administration
- •History of severe allergic or hypersensitivity reactions to STA-9090 or docetaxel or their diluents or excipients
- •Baseline QTc >470 msec or previous history of QT prolongation while taking other medications
- •Peripheral neuropathy > Grade 1
- •Ventricular ejection fraction less than or equal to 55% at baseline
- •Treatment with chronic immunosuppressants. However subjects may receive steroids for stable CNS metastases
- •Women who are pregnant or lactating
- •Uncontrolled intercurrent illness
研究组 & 干预措施
STA-9090 and Docetaxel
Experimental
STA-9090 (ganetespib) and Docetaxel
干预措施: STA-9090 (ganetespib) with Docetaxel (Drug)
结局指标
主要结局
Safety of STA-9090 (ganetespib) and docetaxel combination
时间窗: June 2011
The number of adverse events will be used as a measure of safety
次要结局
- Pharmacokinetics(June 2011)
研究者
研究点 (1)
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