A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Part A: Safety
研究概览
简要总结
This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically proven, newly diagnosed glioblastoma multiforme
- •Age ≥ 18 years and < 70 years
- •Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 70
- •Have adequate bone marrow function , liver function, and kidney function before starting therapy
- •Begin study therapy no more than 6 weeks after surgery or biopsy
- •Subjects that have had surgery must have an MRI ≤ 72 hours after surgery
排除标准
- •Have a carmustine implant (e.g., Gliadel® Wafer)
- •Have uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg for more than 1 week)
- •Have a left ventricular ejection fraction below the lower limit of the reference range for the institution, as measured by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
- •Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution
- •Have an increasing steroid requirement, indicative of a rapidly progressive disease
- •Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 2
- •Have had prior cranial radiotherapy
- •Have history of stroke and/or transient ischemic attack within 2 years of screening
- •Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening
- •Be pregnant or breast feeding
- •Have a history of hypersensitivity reaction to Cremophor® EL
- •Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)
研究组 & 干预措施
Verubulin & standard of care (RT & TMZ)
Verubulin, at the dose selected in Part A, plus standard of care Radiation Therapy and Temozolomide
干预措施: Verubulin (Drug)
Standard of care (RT & TMZ)
Standard of care Radiation Therapy and Temozolomide
干预措施: Temozolomide & Radiation Therapy (Drug)
结局指标
主要结局
Part A: Safety
时间窗: 14 weeks
Assess the number and percentage of subjects with adverse events, abnormal laboratory parameters, and ECG changes as measures of safety and tolerability.
Part B: 9 Mo Progression-free survival
时间窗: 9 Month
次要结局
- Part A: Pharmacokinetic Parameters(18 weeks)
- Part B: 6 Mo Progression Free Survival(6 month)
- Overall Survival(18 months)
- Part B: 12 Mo Progression Free Survival(12 months)