A Phase 2 Trial of Paxalisib Combined With a Ketogenic Diet and Metformin for Newly Diagnosed and Recurrent Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Progression-free survival, defined as the survival rate at 6 months
研究概览
简要总结
This study is for patients with newly diagnosed glioblastoma, as well as patients who have recurring glioblastoma. Subjects will be given daily paxalisib and metformin while also maintaining a ketogenic diet.
The purpose of this study is to assess the safety of Paxalisib while maintaining a ketogenic diet (a high fat, low carbohydrate diet) and Metformin (a drug approved by the Food and Drug Administration to treat type 2 diabetes), and to see what effects it has on glioblastoma.
详细描述
This is a two stage, two cohort phase 2 trial of a new blood-brain penetrant PI3K/mTOR inhibitor (paxalisib) combined with a ketogenic diet plus metformin in patients with either newly diagnosed MGMT unmethylated glioblastoma or patients with recurrent glioblastoma regardless of MGMT promoter methylation status.
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
Arm 1: Newly diagnosed MGMT unmethylated glioblastoma
干预措施: Paxalisib (Drug)
Arm 1: Newly diagnosed MGMT unmethylated glioblastoma
干预措施: Metformin (Drug)
Arm 1: Newly diagnosed MGMT unmethylated glioblastoma
干预措施: Ketogenic Diet (Other)
Arm 2: Recurrent glioblastoma, regardless of methylation status
干预措施: Paxalisib (Drug)
Arm 2: Recurrent glioblastoma, regardless of methylation status
干预措施: Metformin (Drug)
Arm 2: Recurrent glioblastoma, regardless of methylation status
干预措施: Ketogenic Diet (Other)
结局指标
主要结局
Progression-free survival, defined as the survival rate at 6 months
时间窗: At 6 months after the start of study treatment
Measured by the occurrence of a progression event as per RANO criteria or death due to any cause prior to 6 months
次要结局
- Overall survival, defined as the time of first study treatment to death from any cause(From the start of study enrollment until death, up to approximately 18 months)
- Change in tumor glucose uptake values(From baseline assessments through 8 weeks post-treatment)
- Change in insulin levels(From baseline assessments through 8 weeks post-treatment)