NCT01246102已完成1 期
Phase I Study of the HSP-90 Inhibitor, AT13387, in Adults With Refractory Solid Tumors
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
- 试验地点
- 1
- 主要终点
- Define the safety and tolerability of AT13387; establishing the MTD of At13387
研究概览
简要总结
Background:
- The experimental drug AT13387 has been shown to have some anticancer effects against tumor cells by blocking a protein that affects other proteins inside certain cancer cells, and helps to prevent the cancer cells from reproducing and spreading. AT13387 has not been tested in humans, and researchers are interested in investigating whether it can be used to treat solid tumors that have not responded to standard treatments.
Objectives:
- To investigate the safety and effectiveness of AT13387 in individuals with solid tumors.
Eligibility:
- Individuals at least 18 years of age who have solid tumors that have not responded to standard treatments.
Design:
- Participants will be screened with a physical examination and medical history, as well as blood tests and tumor imaging studies.
- AT13387 will be given in 28-day cycles of treatment. Participants will receive AT13387 twice a week (2 days in a row) for the first 3 weeks of the cycle, followed by a fourth week without the drug.
- Participants will have regular blood and urine samples, imaging studies, eye examinations, and tumor biopsies to monitor the effects of the treatment.
- Participants will continue treatment with AT13387 unless serious side effects develop or the tumor stops responding to treatment.
详细描述
Background:
- AT13387 is a synthetic Hsp90 inhibitor that has demonstrated improved characteristics over other Hsp90 inhibitors. AT13387 has a long tumor retention half-life and prolonged inhibitory effect on its known oncogenic client proteins.
- AT13387 has demonstrated activity against multiple cancer cell lines and tumor xenografts in pre-clinical models.
Primary Objectives:
- Define the safety and tolerability of AT13387 administered on a QDx2 every week, 3 weeks out of 4 scheduled, in adults with refractory solid tumors.
- Establish the maximum tolerated dose (MTD) of AT13387 administered on a QDx2 every week, 3 weeks out of 4 schedule, in adults with refractory solid tumors.
Secondary Objectives:
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
- 18 Years 至 120 Years(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
1
Experimental
starting at 20 mg/m2
干预措施: AT13387 (Drug)
结局指标
主要结局
Define the safety and tolerability of AT13387; establishing the MTD of At13387
时间窗: 3 weeks
次要结局
- Determine the pharmacokinetics (PK) of AT13387; Assess pharmacodynamic (PD) markers of Hsp90 inhibition and modulation of Hsp90 client proteins by AT13387(After 1 cycle)
研究者
研究点 (1)
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