NCT00892931已完成2 期
Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 56
- 试验地点
- 20
- 主要终点
- To determine the progression-free survival (PFS) rate
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
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
- •Have histologically proven malignant Glioblastoma Multiforme in first or second relapse
- •Have failed prior Fractionated External Beam Cranial Irradiation or IMRT
- •Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy
- •Have a Karnofsky performance status of ≥ 60
- •Have adequate bone marrow function, liver function, and renal function before starting therapy
排除标准
- •Have had more than two relapses
- •Have had radiosurgery
- •Have a cardiac ejection fraction < 50% by MUGA or ECHO
- •Have Troponin-I elevated above the normal range
- •Have an increasing steroid requirement
- •Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage
- •Have active stroke and/or transient ischemic attack not optimally managed
- •Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension)
- •Be pregnant or breast feeding
- •Have had prior hypersensitivity reaction to Cremophor EL
- •Be HIV positive
结局指标
主要结局
To determine the progression-free survival (PFS) rate
时间窗: Six 28-day cycles from start of therapy
次要结局
- Overall survival(36 months)
- Overall response rate(18 months)
研究者
研究点 (20)
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