CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Entinostat +2 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Recurrent or refractory solid tumors, CNS tumors, or lymphoma with histologic verification (or alternative confirmation for specific tumor types)
  • ✓Body surface area ≥1.17 m² at enrollment
  • ✓Able to swallow intact tablets
  • ✓Measurable or evaluable disease
Key exclusion· 11
  • ✕Pregnant or breast-feeding women; post-menarchal girls must have negative pregnancy test
  • ✕Corticosteroids not on stable or decreasing dose for ≥7 days prior to enrollment (or ≥14 days if used for immune adverse events)
  • ✕Currently receiving another investigational drug
  • ✕Currently receiving other anti-cancer agents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02780804
NCT02780804Phase 1Completed
CompareCT.gov

A Phase 1 Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

National Cancer Institute (NCI)·interventional·Posted May 24, 2016·Updated Oct 17, 2023

In Brief

A Phase 1 clinical trial evaluating Entinostat, Laboratory Biomarker Analysis, and 1 other intervention for Brain Stem Neoplasm and 9 related conditions. Completed, enrolled 21 participants across 21 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain 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
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 24, 2016
Enrollment StartJan 6, 2017
Primary CompletionJun 30, 2021
Study CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.1 years ago

Interventions

Entinostatdrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies