Adults 12 Months to 21, any sex, with Brain Stem Neoplasm or Pineal Region Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of EntinostatPrimary· 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.
Group
Value
95% CI
Treatment (Entinostat)
4
Frequency of Adverse Events for EntinostatPrimary· 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.
Group
Value
95% CI
Stratum 1 With 3 mg/m²
5
Stratum 1 With 4 mg/m²
7
PK Part With 4 mg/m²
5
Half-life of EntinostatPrimary· 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.
Group
Value
95% CI
Stratum 1 With 3 mg/m²
50.96
27.38 – 103.66
Stratum 1 With 4 mg/m²
46.04
40.51 – 81.32
PK Part With 4 mg/m²
44.23
29.86 – 103.74
Peak Plasma Concentration of Entinostat: C-MaxPrimary· 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.
Group
Value
95% CI
Stratum 1 With 3 mg/m²
54.4
5.19 – 136.00
Stratum 1 With 4 mg/m²
61.5
14.00 – 107.00
PK Part With 4 mg/m²
23.8
19.10 – 293.00
Total Area Under the Plasma Concentration Curve of Entinostat: AUCPrimary· 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.
Group
Value
95% CI
Stratum 1 With 3 mg/m²
755
252 – 1320
Stratum 1 With 4 mg/m²
1111
816 – 1910
PK Part With 4 mg/m²
1147
1074 – 2349
Time to Reach Maximum Plasma Concentration of Entinostat: T-MaxPrimary· 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.
Group
Value
95% CI
Stratum 1 With 3 mg/m²
1.01
0.53 – 6.00
Stratum 1 With 4 mg/m²
0.59
0.50 – 24.55
PK Part With 4 mg/m²
1
0.50 – 24.08
Antitumor Activity of EntinostatSecondary· 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
Group
Value
95% CI
Stratum 1 With 3 mg/m²
0
Stratum 1 With 4 mg/m²
0
PK Part With 4 mg/m²
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 4 years 9 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Stratum 1 With 3 mg/m²
Serious: 5/6 (83%)
Deaths: 1/6
Stratum 1 With 4 mg/m²
Serious: 7/9 (78%)
Deaths: 0/9
PK Part With 4 mg/m²
Serious: 5/6 (83%)
Deaths: 2/6
Serious adverse events (62 terms)
Reaction
System
Stratum 1 With 3 mg/m²
Stratum 1 With 4 mg/m²
PK Part With 4 mg/m²
Neutrophil count decreased
Investigations
—
—
—
Headache
Nervous system disorders
—
—
—
Hydrocephalus
Nervous system disorders
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
Lymphocyte count decreased
Investigations
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Abducens nerve disorder
Nervous system disorders
—
—
—
Acidosis
Metabolism and nutrition disorders
—
—
—
Agitation
Psychiatric disorders
—
—
—
Alanine aminotransferase increased
Investigations
—
—
—
Anal hemorrhage
Gastrointestinal disorders
—
—
—
Anemia
Blood and lymphatic system disorders
—
—
—
Ascites
Gastrointestinal disorders
—
—
—
Aspartate aminotransferase increased
Investigations
—
—
—
Aspiration
Respiratory, thoracic and mediastinal disorders
—
—
—
Ataxia
Nervous system disorders
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
Confusion
Psychiatric disorders
—
—
—
Death NOS
General disorders
—
—
—
Delirium
Psychiatric disorders
—
—
—
Delusions
Psychiatric disorders
—
—
—
Depressed level of consciousness
Nervous system disorders
—
—
—
Depression
Psychiatric disorders
—
—
—
Diarrhea
Gastrointestinal disorders
—
—
—
Dysarthria
Nervous system disorders
—
—
—
Other adverse events (247 terms — click to expand)
This phase I trial studies the side effects and best dose of entinostat in treating pediatric patients with solid tumors that have come back or have not responded to treatment. Entinostat may block some of the enzymes needed for cell division and it may help to kill tumor cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07441486 — A Single-arm, Prospective, Phase II Clinical Study of the Combination of Entinostat and Oral Paclitaxel in the Treatment
· Phase 2
· not yet recruiting
NCT07261592 — Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer
· Phase 1, PHASE2
· not yet recruiting
NCT05898828 — Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Th
· Phase 1, PHASE2
· withdrawn
NCT05053971 — Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT04708470 — A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel,
· Phase 1, PHASE2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 17 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02780804.