A phase 1 study of entinostat in children and adolescents with recurrent or refractory solid tumors, including CNS tumors: Trial ADVL1513, Pediatric Early Phase-Clinical Trial Network (PEP-CTN).

ABSTRACT:

Background

Entinostat is an oral small molecule inhibitor of class I histone deacetylases (HDAC), which has not previously been evaluated in pediatrics. We conducted a phase I trial to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D), toxicity profile, pharmacokinetics (PK), and pharmacodynamics (PD) of entinostat in children with relapsed or refractory solid tumors including central nervous system (CNS) malignancies.

Methods

A rolling six dose escalation design evaluated two dose levels. Entinostat oral tablet formulation was administered once per week, four doses per 28-day cycle. PK and PD studies were performed.

Results

Twenty-one eligible patients' median (range) age was 14 years (6-20). Six subjects were treated at 3 mg/m² dose

SUBMITTER: Bukowinski A 

PROVIDER: S-EPMC9176707 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature