Trial · NCT02780804

Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

NCT02780804, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2023-01-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors. Trials, record NCT02780804. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02780804

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
NCT number: NCT02780804
Status: Completed
Phases: Phase 1
Enrollment: 21 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Brain Stem Neoplasm, Pineal Region Neoplasm, Recurrent Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Primary Central Nervous System Neoplasm, Recurrent Visual Pathway Glioma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Primary Central Nervous System Neoplasm, Refractory Visual Pathway Glioma
Interventions: Entinostat, Laboratory Biomarker Analysis, Pharmacological Study
First posted: 2016-05-24
Last updated: 2023-10-17
Results first posted: 2023-01-31

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of Entinostat	Up to 28 days	The MTD/RP2D will be defined as the maximum dose at which fewer than one-third of patients experience dose limiting toxicity during cycle 1 of therapy among 6 toxicity-evaluable patients. The frequency of cycle 1 dose limiting toxicities will be summarized by dose level among patients in the dose escalation part of the study.
Primary	Frequency of Adverse Events for Entinostat	Up to 28 days	The frequency of patients with at least one Grade 3 or greater adverse event that are at least possibly attributable to entinostat during cycle 1 will be summarized by study part, dose level.
Primary	Half-life of Entinostat	Plasma concentrations were measured at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.	The median (min, max) Half-Life of entinostat stratified by study part and dose level. The half-life (t1/2) was calculated using the equation t1/2 = 0.693/λz, where the terminal elimination rate constant (λz) was determined from a least-squares regression of the log-transformed plasma concentration vs. time data for the last 3 - 4 time points.
Primary	Peak Plasma Concentration of Entinostat: C-Max	Up to 96 hours	The median (min, max) of the peak plasma concentration of entinostat stratified by study part, dose level. Time points were assessed at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.
Primary	Total Area Under the Plasma Concentration Curve of Entinostat: AUC	Up to 96 hours	The median (min, max) of the total area under the plasma concentration curve of entinostat stratified by study part, dose level. Time points were assessed at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.
Primary	Time to Reach Maximum Plasma Concentration of Entinostat: T-Max	Up to 96 hours	The median (min, max) of the time to reach maximum plasma concentration of entinostat stratified by study part, dose level. Time points were assessed at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.
Secondary	Antitumor Activity of Entinostat	Up to 4 years 9 months	Frequency of response to entinostat per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and/or assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, stratified by study part and dose
Secondary	Change in Histone H3 Acetylation of Entinostat	Up to 28 days	Median (IQR) change in H3 acetylation in peripheral blood mononuclear cells (PBMCs) versus baseline stratified by study part, dose level.
Secondary	Change in Histone H4 Acetylation of Entinostat	Up to 28 days	Median (IQR) change in H4 acetylation in PBMCs versus baseline stratified by study part, dose level.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of Entinostat	Up to 28 days		mg/m²	NUMBER
PRIMARY	Frequency of Adverse Events for Entinostat	Up to 28 days	All eligible enrolled patients.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Half-life of Entinostat	Plasma concentrations were measured at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.	All eligible enrolled patients.	Hours	MEDIAN
PRIMARY	Peak Plasma Concentration of Entinostat: C-Max	Up to 96 hours	All eligible enrolled patients.	ng/ml	MEDIAN
PRIMARY	Total Area Under the Plasma Concentration Curve of Entinostat: AUC	Up to 96 hours	All eligible enrolled patients.	hr*ng/mL	MEDIAN
PRIMARY	Time to Reach Maximum Plasma Concentration of Entinostat: T-Max	Up to 96 hours	All eligible enrolled patients.	Hours	MEDIAN
SECONDARY	Antitumor Activity of Entinostat	Up to 4 years 9 months	All eligible enrolled patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Histone H3 Acetylation of Entinostat	Up to 28 days	Data were not collected
SECONDARY	Change in Histone H4 Acetylation of Entinostat	Up to 28 days	Data were not collected

Source ClinicalTrials.gov

Results by group19

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of Entinostat	Treatment (Entinostat)	4		mg/m²
Frequency of Adverse Events for Entinostat	Stratum 1 With 3 mg/m²	5		Participants
Frequency of Adverse Events for Entinostat	Stratum 1 With 4 mg/m²	7		Participants
Frequency of Adverse Events for Entinostat	PK Part With 4 mg/m²	5		Participants
Half-life of Entinostat	Stratum 1 With 3 mg/m²	50.96	Full Range 27.38 to 103.66	Hours
Half-life of Entinostat	Stratum 1 With 4 mg/m²	46.04	Full Range 40.51 to 81.32	Hours
Half-life of Entinostat	PK Part With 4 mg/m²	44.23	Full Range 29.86 to 103.74	Hours
Peak Plasma Concentration of Entinostat: C-Max	Stratum 1 With 3 mg/m²	54.4	Full Range 5.19 to 136.00	ng/ml
Peak Plasma Concentration of Entinostat: C-Max	Stratum 1 With 4 mg/m²	61.5	Full Range 14.00 to 107.00	ng/ml
Peak Plasma Concentration of Entinostat: C-Max	PK Part With 4 mg/m²	23.8	Full Range 19.10 to 293.00	ng/ml

1 to 10 of 19Source ClinicalTrials.gov

See all 19 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stratum 1 With 3 mg/m²	6
Overall Study	STARTED	Stratum 1 With 4 mg/m²	9
Overall Study	STARTED	PK Part With 4 mg/m²	6
Overall Study	COMPLETED	Stratum 1 With 3 mg/m²	0
Overall Study	COMPLETED	Stratum 1 With 4 mg/m²	0
Overall Study	COMPLETED	PK Part With 4 mg/m²	0
Overall Study	NOT COMPLETED	Stratum 1 With 3 mg/m²	6
Overall Study	NOT COMPLETED	Stratum 1 With 4 mg/m²	9
Overall Study	NOT COMPLETED	PK Part With 4 mg/m²	6

Source ClinicalTrials.gov

Adverse events927

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal distension	Gastrointestinal disorders	Stratum 1 With 3 mg/m²	1	6
other	Abdominal distension	Gastrointestinal disorders	Stratum 1 With 4 mg/m²	2	9
other	Abdominal distension	Gastrointestinal disorders	PK Part With 4 mg/m²	1	6
other	Abdominal pain	Gastrointestinal disorders	Stratum 1 With 3 mg/m²	2	6
other	Abdominal pain	Gastrointestinal disorders	Stratum 1 With 4 mg/m²	2	9
other	Abdominal pain	Gastrointestinal disorders	PK Part With 4 mg/m²	2	6
other	Abducens nerve disorder	Nervous system disorders	Stratum 1 With 3 mg/m²	1	6
other	Abducens nerve disorder	Nervous system disorders	Stratum 1 With 4 mg/m²	0	9
other	Abducens nerve disorder	Nervous system disorders	PK Part With 4 mg/m²	0	6
other	Acoustic nerve disorder NOS	Nervous system disorders	Stratum 1 With 3 mg/m²	1	6

1 to 10 of 927Source ClinicalTrials.gov

See all 927 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stratum 1 With 3 mg/m²	1	6
Total, all-cause mortality	Stratum 1 With 4 mg/m²	0	9
Total, all-cause mortality	PK Part With 4 mg/m²	2	6
Total, other adverse events	Stratum 1 With 3 mg/m²	6	6
Total, other adverse events	Stratum 1 With 4 mg/m²	9	9
Total, other adverse events	PK Part With 4 mg/m²	6	6
Total, serious adverse events	Stratum 1 With 3 mg/m²	5	6
Total, serious adverse events	Stratum 1 With 4 mg/m²	7	9
Total, serious adverse events	PK Part With 4 mg/m²	5	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1CA097452	Pediatric Phase 1/Pilot Consortium	WEIGEL, BRENDA J.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2009 to 2018

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02780804

GET https://conductscience.org/api/trials/v1/NCT02780804/events?page=2

API reference For AI assistants