NCT00393965已完成1 期
Phase 1 Open Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, in Subjects With Refractory Brain Metastases
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
Phase 1, Multiple dose Study of MPC-6827 in Subjects with Refractory Brain Metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Refractory Brain Metastases
- •At least 1 measurable intracranial lesion as defined by RECIST
- •ECOG less than or equal to 1
- •Adequate hematology/organ function
- •No baseline peripheral or central neuropathy above grade 1
排除标准
- •Hypersensitivity to Cremophor EL
- •Pregnant or Lactating
- •Spinal Cord Compression
- •Pre-existing dementia/cognitive disfunction
- •Require Neupogen or Neulasta to Maintain Neutrophil Count
- •Have Primary Brain Cancer
- •Have History of Ischemic Heart Disease
- •Have Diabetes
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 1 year
Pharmacokinetics
时间窗: 1 year
次要结局
- Antitumor Activity(2 years)
研究者
研究点 (2)
Loading locations...
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