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NCT02780804 · OUTCOME

Time to Reach Maximum Plasma Concentration of Entinostat: T-Max

Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors · Source last updated 2023-10-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
Time frame
Up to 96 hours

What was measured

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.

Analysis population: All eligible enrolled patients.

Groups in this outcome

Stratum 1 With 3 mg/m²

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

Stratum 1 With 4 mg/m²

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

PK Part With 4 mg/m²

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)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Stratum 1 With 3 mg/m²6
Stratum 1 With 4 mg/m²9
PK Part With 4 mg/m²6

Reported measurements

Source class 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stratum 1 With 3 mg/m²1.01Not reported0.536.00Not reported
Stratum 1 With 4 mg/m²0.59Not reported0.5024.55Not reported
PK Part With 4 mg/m²1Not reported0.5024.08Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.53
        upper Limit
        6.00
        value
        1.01
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        24.55
        value
        0.59
      3. group Id
        OG002
        lower Limit
        0.50
        upper Limit
        24.08
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      6
    units
    Participants
description
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.
dispersion Type
Full Range
groups
  1. description
    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
    id
    OG000
    title
    Stratum 1 With 3 mg/m²
  2. description
    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
    id
    OG001
    title
    Stratum 1 With 4 mg/m²
  3. description
    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)
    id
    OG002
    title
    PK Part With 4 mg/m²
param Type
MEDIAN
population Description
All eligible enrolled patients.
reporting Status
POSTED
time Frame
Up to 96 hours
title
Time to Reach Maximum Plasma Concentration of Entinostat: T-Max
type
PRIMARY
unit Of Measure
Hours

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice