Spots Global Cancer Trial Database for Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma

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Trial Identification

Brief Title: Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma

Official Title: A Phase 2 Trial of Paxalisib Combined With a Ketogenic Diet and Metformin for Newly Diagnosed and Recurrent Glioblastoma

Study ID: NCT05183204

Conditions

Glioblastoma

Interventions

Paxalisib

Metformin

Ketogenic Diet

Study Description

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.