A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of EPO906
研究概览
简要总结
The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.
详细描述
- To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
- To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
- To evaluate tumor response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Requires a minimum of 3 weeks of radiation therapy
- •Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy
- •World Health Organization (WHO) performance status equal to or less than 2
- •Life expectancy equal to or greater than 3 months
排除标准
- •Any peripheral neuropathy
- •Unresolved diarrhea greater than grade 1
- •Patients who received any other investigational compound within the past 28 days
- •Severe cardiac insufficiency
- •Patients on Coumadin
研究组 & 干预措施
Cohort 1 Brain Tumors
The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.
干预措施: EPO906 (epothilone B) (Drug)
Cohort 2 Head and Neck Tumors
The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.
干预措施: EPO906 (epothilone B) (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of EPO906
时间窗: Baseline to 7 weeks
次要结局
- Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy(Baseline to 7 weeks)