Trial Outcomes & Findings for Entinostat Neuroendocrine (NE) Tumor (NCT NCT03211988)
NCT ID: NCT03211988
Last Updated: 2026-03-02
Results Overview
Objective response defined as complete response (CR) (Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.) and partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) and will be determined from each participant's best confirmed response during protocol therapy. Response as evaluated per RECIST 1.1 criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 44 months
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
Entinostat
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Entinostat
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Entinostat Neuroendocrine (NE) Tumor
Baseline characteristics by cohort
| Measure |
Entinostat
n=5 Participants
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
|
|---|---|
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Age, Continuous
|
75 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Up to 44 monthsObjective response defined as complete response (CR) (Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.) and partial response (PR) (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) and will be determined from each participant's best confirmed response during protocol therapy. Response as evaluated per RECIST 1.1 criteria.
Outcome measures
| Measure |
Entinostat
n=4 Participants
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
|
|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 45 monthsTime from study enrollment until disease progression or death.
Outcome measures
| Measure |
Entinostat
n=4 Participants
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
|
|---|---|
|
Duration of Progression-Free Survival (PFS)
|
381 days
Interval 232.0 to 754.0
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SECONDARY outcome
Timeframe: Up to 45 monthsThe length of time from either the date of diagnosis or start of treatment that years participants diagnosed with the disease are still alive.
Outcome measures
| Measure |
Entinostat
n=4 Participants
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
|
|---|---|
|
Duration of Overall Survival (OS)
|
1422 days
Interval 1163.0 to 1611.0
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Zero analyzed as there were no participants that achieved CR or PR.
Time from documentation of tumor response to disease progression in participants who achieve CR or PR.
Outcome measures
Outcome data not reported
Adverse Events
Entinostat
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Entinostat
n=5 participants at risk
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
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|---|---|
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Cardiac disorders
Cardiac arrest
|
20.0%
1/5 • Through study completion, an average of 3 years
|
Other adverse events
| Measure |
Entinostat
n=5 participants at risk
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Entinostat: Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
|
|---|---|
|
Vascular disorders
Thromboembolic event
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Investigations
Weight gain
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
General disorders
Fever
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
General disorders
Flu-like symptoms
|
60.0%
3/5 • Through study completion, an average of 3 years
|
|
General disorders
Night sweats
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Investigations
Weight loss
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Through study completion, an average of 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Through study completion, an average of 3 years
|
|
Gastrointestinal disorders
Bloating
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
General disorders
Fatigue
|
60.0%
3/5 • Through study completion, an average of 3 years
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Through study completion, an average of 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Investigations
Neutrophil count decreased
|
80.0%
4/5 • Through study completion, an average of 3 years
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Through study completion, an average of 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Through study completion, an average of 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place