NCT00688116Unknown1 期
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug.
研究概览
简要总结
An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)
详细描述
This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-
- •Peripheral neuropathy ?
- •Must have acceptable organ and marrow function per protocol parameters.
- •No clinically significant ventricular arrythmias or ischemia.
排除标准
- •Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks..
- •No previous radiation to >25% of total bone marrow.
- •No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation.
- •No primary brain tumors or active brain metastases.
- •No use of any investigational agents within 4 weeks.
- •No treatment with chronic immunosuppressants.
- •No uncontrolled, intercurrent illness.
研究组 & 干预措施
ganetespib
Experimental
干预措施: STA 9090 (ganetespib) (Drug)
结局指标
主要结局
The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug.
时间窗: Cycle 1
次要结局
未报告次要终点
研究者
研究点 (5)
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