NCT00306618已完成2 期
A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to 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
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- 6 month progression free survival and median overall survival
研究概览
简要总结
This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)
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
- •Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
- •18 years or older
- •An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks)
- •Karnofsky performance score equal to or greater than 70%
- •Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters
- •Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN
- •Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry
- •Agree to use effective contraceptive methods
排除标准
- •Current, active systemic bleeding or excessive risk of bleeding
- •Be pregnant or lactating; not employing effective birth control
- •Concurrent severe and/or uncontrolled medical disease
- •Impairment of gastrointestinal (GI) function/disease
- •Requirement for therapy with coumadin (warfarin sodium)
- •Patient is less than 5 years free of another primary malignancy
- •Patients unwilling to or unable to comply with the protocol
- •Grade 2 or greater peripheral sensory neuropathy
结局指标
主要结局
6 month progression free survival and median overall survival
时间窗: time of progression; survival
次要结局
未报告次要终点
研究者
研究点 (1)
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