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NCT02780804 · OUTCOME

Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of Entinostat

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
NUMBER
Unit
mg/m²
Interval / dispersion
Not reported
Time frame
Up to 28 days

What was measured

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.

Groups in this outcome

Treatment (Entinostat)

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

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

Analysis denominator · Participants

GroupSource count
Treatment (Entinostat)21

Reported measurements

Source class 1
Values in mg/m² · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Entinostat)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
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.
groups
  1. description
    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
    id
    OG000
    title
    Treatment (Entinostat)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 28 days
title
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (R2PD) of Entinostat
type
PRIMARY
unit Of Measure
mg/m²

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

Preserved source evidence · Not medical advice