drugset / Trial / NCT05183204

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

NCT05183204

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-02-14
Primary completion
2026-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg
Subject Paxalisib Small molecule 60 mg

Indications