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NCT02780804 · STUDY IN CONTEXT

Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

→

primary · POSTED

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.

All eligible enrolled patients.

→

primary · POSTED

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.

All eligible enrolled patients.

→

primary · POSTED

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.

All eligible enrolled patients.

→

primary · POSTED

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.

All eligible enrolled patients.

→

primary · POSTED

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.

All eligible enrolled patients.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-central-nervous-system-tumors-recurrent-31ec95fa
nct id
NCT02780804
trial label
Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0000
    source section id
    NCT02780804-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of Entinostat
    endpoint definition
    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.
    time origin
    Up to 28 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0001
    source section id
    NCT02780804-om-0001
    source outcome index
    1
    endpoint
    Frequency of Adverse Events for Entinostat
    endpoint definition
    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.
    time origin
    Up to 28 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible enrolled patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0002
    source section id
    NCT02780804-om-0002
    source outcome index
    2
    endpoint
    Half-life of Entinostat
    endpoint definition
    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.
    time origin
    Plasma concentrations were measured at 0, 0.5, 1, 3, 6, 24, and 48-96 hours post-dose during cycle 1, day 1.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible enrolled patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0003
    source section id
    NCT02780804-om-0003
    source outcome index
    3
    endpoint
    Peak Plasma Concentration of Entinostat: C-Max
    endpoint definition
    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.
    time origin
    Up to 96 hours
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible enrolled patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0004
    source section id
    NCT02780804-om-0004
    source outcome index
    4
    endpoint
    Total Area Under the Plasma Concentration Curve of Entinostat: AUC
    endpoint definition
    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.
    time origin
    Up to 96 hours
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible enrolled patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0005
    source section id
    NCT02780804-om-0005
    source outcome index
    5
    endpoint
    Time to Reach Maximum Plasma Concentration of Entinostat: T-Max
    endpoint definition
    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.
    time origin
    Up to 96 hours
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible enrolled patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Entinostat)
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CNS tumors, who receive entinostat on Days 1, 8, 15, and 22 of a 28-day cycle
    analyzed count
    21
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Stratum 1 With 3 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Stratum 1 With 4 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0001
    arm key
    OG002
    arm label
    PK Part With 4 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0001#groups/OG002
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Stratum 1 With 3 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Stratum 1 With 4 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0002
    arm key
    OG002
    arm label
    PK Part With 4 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0002#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Stratum 1 With 3 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Stratum 1 With 4 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0003
    arm key
    OG002
    arm label
    PK Part With 4 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0003#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Stratum 1 With 3 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Stratum 1 With 4 mg/m²
    regimen
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02780804-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    harm key
    EG000
    source section id
    NCT02780804-ae
    event group key
    EG000
    event group label
    Stratum 1 With 3 mg/m²
    serious affected
    5
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    0
    collection period
    Up to 4 years 9 months
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    harm key
    EG001
    source section id
    NCT02780804-ae
    event group key
    EG001
    event group label
    Stratum 1 With 4 mg/m²
    serious affected
    7
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    0
    collection period
    Up to 4 years 9 months
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-central-nervous-system-tumors-recurrent-31ec95fa
    nct id
    NCT02780804
    harm key
    EG002
    source section id
    NCT02780804-ae
    event group key
    EG002
    event group label
    PK Part With 4 mg/m²
    serious affected
    5
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    0
    collection period
    Up to 4 years 9 months
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice