Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Safety and Tolerability (Maximum Tolerated Dose)
研究概览
简要总结
The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future.
The study drug is designed to reduce the activity of a protein known as "heat shock protein 90", or "Hsp90". Hsp90 is found in every cell in the human body and normally helps those cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow the growth, and reduce the survival, of those cancer cells.
详细描述
This is a dose escalation study. As subjects participating in the study tolerate a specific dose level, the new subjects entering will be given a higher dose of the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •recurrent cancer refractory to available systemic therapy
- •18 years old or older
- •predicted life expectancy equal or greater to 8 weeks
- •at least 4 weeks post chemotherapy, immunotherapy, surgery, or radiation therapy and have recovered from treatment toxicities
- •Karnofsky Performance Status equal or greater to 60 or ECOG equal or less than 2
- •adequate organ function based on hematological, liver, and renal function
- •LVEF greater than the lower limit of normal for the institution, as measured by MUGA or by echocardiography
- •wash-out period before first dose os study drug if a protocol prohibited medication is being discontinued
排除标准
- •pregnant or breastfeeding
- •received any other anti-cancer treatment or investigational therapy within 28 days prior to Cycle 1 Day 1
- •symptoms of heart failure equal or greater to Class III (by NYHA criteria)
- •impaired cardiac function or clinically significant cardiac diseases
- •concurrent treatment with medications that either markedly induce or inhibit CYP3A4
- •concurrent treatment with medications that have a relative risk of prolonging the QT interval or inducing torsades de pointes if treatment cannot be discontinued or switched to a different medication prior to study drug
结局指标
主要结局
Safety and Tolerability (Maximum Tolerated Dose)
时间窗: After each cohort is enrolled .
次要结局
- Study Drug Pharmacokinetics(Cycle 1)
- Evidence of anti-tumor activity of study drug.(After each odd cycle and end of study.)