Phase II Study of Ixabepilone in Patients With Metastatic Breast Cancer and a Prospective Evaluation of Its Effects on the Ultrastructure of Neurons
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Axons With Abnormal Morphology
研究概览
简要总结
Primary Objectives
- Assess ultrastructure changes in dermal myelinated nerves of patients who receive ixabepilone chemotherapy
- Detailed characterization of peripheral neuropathy in patients who receive ixabepilone
Secondary Objectives
-
Clinical benefit rate
-
Time to progression ( TTP)
-
Toxicity
-
Exploratory studies:
-
Relation of MDR 1 and TRKA polymorphisms to evolution of ultrastructural neurologic changes observed in neurons.
-
Relation of NGF, IL8, and IL10 to the development of clinical symptoms and ultrastructural changes in neurons.
详细描述
Eligible patient population:
- Stage 4 breast cancer
- Resolution from toxicity of prior therapy to ≤ CTC grade 1 ( except alopecia)
- No limit on prior number of therapies to treat cancer
- Adequate organ function
- Life expectancy greater than 3 months
Treatment: ixabepilone 40 mg/m2 Q3w over 3 hours
Evaluation on Study:
I. Efficacy evaluation:
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 —（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
Ixabepilone
Participants are treated with Ixabepilone.
干预措施: ixabepilone (Drug)
结局指标
主要结局
Axons With Abnormal Morphology
时间窗: Baseline and Over 7 cycles of treatment, approximately 21 weeks
Digital photographs for morphometry were captured at a magnification of 8000-16,000x and the photos were uploaded onto an imaging platform of transmission electron microscope (iTEM) (Olympus, Mu¨nster, Germany). The figures were enlarged by 50%, and an individual linear array was used to measure the axonal diameter (cross-sectional area) and the number of unmyelinated axons per Remak Schwann cell was enumerated according to the established methodology.
次要结局
未报告次要终点