1
Participants
Start Date
February 10, 2022
Primary Completion Date
June 9, 2023
Study Completion Date
June 9, 2023
Copanlisib
Copanlisib will be infused intravenously on days 1, 8, 15 of each cycle, over 1 hour, of 28-day cycles.
Ketogenic Diet
"In cycle 1, patients will first start the ketogenic diet for 7 days (Day -6 to Day 0).~Only the patients who demonstrate compliance and tolerance with the ketogenic diet, as confirmed by pertinent blood and urine tests and a diary of diet, will be allowed to continue the study and start copanlisib on Day 1. The ketogenic diet will continue daily throughout the treatment days.~In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.~The ketogenic diet will then continue daily throughout the treatment days."
Columbia University Irving Medical Center, New York
Collaborators (1)
Bayer
INDUSTRY
Columbia University
OTHER