Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Registration Number
- NCT05183204
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 2: Recurrent glioblastoma, regardless of methylation status Ketogenic Diet - Arm 1: Newly diagnosed MGMT unmethylated glioblastoma Ketogenic Diet - Arm 1: Newly diagnosed MGMT unmethylated glioblastoma Metformin - Arm 1: Newly diagnosed MGMT unmethylated glioblastoma Paxalisib - Arm 2: Recurrent glioblastoma, regardless of methylation status Metformin - Arm 2: Recurrent glioblastoma, regardless of methylation status Paxalisib -
- Primary Outcome Measures
Name Time Method Progression-free survival, defined as the survival rate at 6 months 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
- Secondary Outcome Measures
Name Time Method 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 Measured by FDG-PET/DCE MRI
Change in insulin levels From baseline assessments through 8 weeks post-treatment Evaluated by the mean and standard deviation of values over time
Trial Locations
- Locations (1)
Weill Cornell Medicine
🇺🇸New York, New York, United States