Study of Copanlisib and Ketogenic Diet

PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

February 10, 2022

Primary Completion Date

June 9, 2023

Study Completion Date

June 9, 2023

Conditions
Follicular LymphomaEndometrial Cancer
Interventions
DRUG

Copanlisib

Copanlisib will be infused intravenously on days 1, 8, 15 of each cycle, over 1 hour, of 28-day cycles.

OTHER

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."

Trial Locations (1)

10032

Columbia University Irving Medical Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Columbia University

OTHER