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Study of Copanlisib and Ketogenic Diet

NCT04750941 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-03-04

Study results available
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Summary

This is a multicenter, open label, pilot phase II study of the PI3K inhibitor copanlisib in combination with a ketogenic diet in the treatment of patients with one of the following malignancies: (a) relapsed or refractory (R/R) follicular lymphoma (FL), (b) R/R endometrial cancer (EC) with a documented activating mutation in PIK3CA or loss of phosphatase and tensin homolog (PTEN).

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Jennifer E. Amengual, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-06-09
Completion
2023-06-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750941 on ClinicalTrials.gov