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

PHASE2RecruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

February 14, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Glioblastoma
Interventions
DRUG

Paxalisib

Patients will receive paxalisib starting at a dose of 45 mg/day. If well tolerated after 28 days, the dose of paxalisib will be increased to 60 mg/day.

DRUG

Metformin

Patients will receive metformin on Cycle 1, Day 1 at a starting dose of 850 mg QD, and if tolerated, will be increased to 850 mg BID on Cycle 2, Day 1 (1700 mg/day). If that dose is tolerated, metformin will be increased to 850 mg TID (2550 mg/day) beginning on Cycle 3, Day 1.

OTHER

Ketogenic Diet

The ketogenic diet is high-fat, low carbohydrate diet. Ketogenic diet will be maintained on a continuous basis starting on Cycle 1, Day 1 and continuing throughout the trial.

Trial Locations (1)

10065

RECRUITING

Weill Cornell Medicine, New York

Sponsors
All Listed Sponsors
collaborator

Kazia Therapeutics Limited

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER

NCT05183204 - Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma | Biotech Hunter | Biotech Hunter