NCT00295815已完成3 期
Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening).
研究概览
简要总结
This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme).
- •Your cancer has returned following therapy.
- •Patient may have undergone prior surgery to remove cancer.
- •Patient must be able to care for self.
排除标准
- •Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry.
- •Patients receiving medication for seizures must discontinue 14 days prior to enrolling.
- •Cannot be on blood thinning medication at study enrollment.
- •Cannot be on other medicines to prevent cancer at study enrollment.
- •Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.
研究组 & 干预措施
A
Experimental
干预措施: enzastaurin (Drug)
B
Active Comparator
干预措施: lomustine (Drug)
结局指标
主要结局
The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening).
时间窗: baseline to measured progressive disease (PD)
次要结局
- To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).(time of response to progressive disease)
- To measure changes from baseline and a neurologic exam.(baseline, each cycle)
- To review all bad reactions reported by the patient and detected in blood tests.(each cycle)
- To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.(over entire study)
- To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients.(baseline, cycle 2, end of study)
- To determine through blood tests how long the medication is in the patient's body.(cycle 1, cycle 4)
- To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).(over entire study)
研究者
研究点 (1)
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