33
Participants
Start Date
February 14, 2022
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
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.
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.
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.
RECRUITING
Weill Cornell Medicine, New York
Collaborators (1)
Kazia Therapeutics Limited
INDUSTRY
Weill Medical College of Cornell University
OTHER