Trial Outcomes & Findings for Study of Copanlisib and Ketogenic Diet (NCT NCT04750941)
NCT ID: NCT04750941
Last Updated: 2025-03-04
Results Overview
ORR will be determined from the number of individuals with a complete response (CR) and number of individuals with a partial response (PR)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Up to 58 weeks or 4 weeks after the last dose
Results posted on
2025-03-04
Participant Flow
Participant milestones
| Measure |
Follicular Lymphoma (FL)
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Copanlisib and Ketogenic Diet
Baseline characteristics by cohort
| Measure |
Follicular Lymphoma (FL)
n=1 Participants
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 58 weeks or 4 weeks after the last dosePopulation: No participants were assigned to the EC arm due to enrollment challenges.
ORR will be determined from the number of individuals with a complete response (CR) and number of individuals with a partial response (PR)
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=1 Participants
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
100 percent of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 58 weeks or 4 weeks after the last dosePopulation: No participants were assigned to the EC arm due to enrollment challenges.
Total number of participants with a CR.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=1 Participants
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
|---|---|---|
|
Complete Response (CR) Rate
|
0 percent of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 58 weeks or 4 weeks after the last dosePopulation: No participants were assigned to the EC arm due to enrollment challenges.
Total number of participants with a PR.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=1 Participants
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
|---|---|---|
|
Partial Response (PR) Rate
|
100 percent of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 58 weeks or 4 weeks after the last dosePopulation: No participants were assigned to the EC arm due to enrollment challenges.
ORR will be determined from the number of individuals with a complete response (CR) and number of individuals with a partial response (PR).
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=1 Participants
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
|---|---|---|
|
ORR at the Simon Stage I Analysis
|
100 percent of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 58 weeks or 4 weeks after the last dosePopulation: No participants were assigned to the EC arm due to enrollment challenges.
Total # of patients who are compliant with the ketogenic diet.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=1 Participants
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
|---|---|---|
|
Patient Compliance With the Ketogenic Diet
|
1 Participants
|
—
|
Adverse Events
Follicular Lymphoma (FL)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Endometrial Cancer (EC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Follicular Lymphoma (FL)
n=1 participants at risk
In cycle 1, patients with FL will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
Endometrial Cancer (EC)
In cycle 1, patients with EC will first start the ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
|
|---|---|---|
|
General disorders
Weight loss
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
Immune system disorders
Neutrophil count decreased
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
Cardiac disorders
Dyspnea
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
General disorders
Fever
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
General disorders
Bone pain
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
General disorders
Muscle cramp
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
General disorders
Flushing
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
Eye disorders
Dry eye
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
—
0/0 • Up to 58 weeks
No participants were assigned to the EC arm due to enrollment challenges.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place