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NCT02717455 · OUTCOME

Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 1

Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma · Source last updated 2024-04-25

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

Measure
NUMBER
Unit
mg/m^2/day
Interval / dispersion
Not reported
Time frame
4 weeks

What was measured

The MTD of panobinostat was defined as the dose at which the continual reassessment method (CRM) estimated that 25% of patients were expected to experience DLTs. Stratum 1 consisted of recurrent or progressive diffuse intrinsic pontine glioma (DIPG) patients who were treated with the "3 times/week, three weeks on, one week off" schedule (1 course = 28 days).

Analysis population: Patients who were enrolled on stratum 1 and were evaluable for dose finding assessment were used to determine the MTD for stratum 1. Of 19 patients enrolled on stratum 1, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 17 patients were used to determine the MTD for stratum I.

Groups in this outcome

Stratum 1

Recurrent/progressive DIPG patients who were treated with the "3 times/week, three weeks on, one week off" schedule.

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 117

Reported measurements

Source class 1
Values in mg/m^2/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 110Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
The MTD of panobinostat was defined as the dose at which the continual reassessment method (CRM) estimated that 25% of patients were expected to experience DLTs. Stratum 1 consisted of recurrent or progressive diffuse intrinsic pontine glioma (DIPG) patients who were treated with the "3 times/week, three weeks on, one week off" schedule (1 course = 28 days).
groups
  1. description
    Recurrent/progressive DIPG patients who were treated with the "3 times/week, three weeks on, one week off" schedule.
    id
    OG000
    title
    Stratum 1
param Type
NUMBER
population Description
Patients who were enrolled on stratum 1 and were evaluable for dose finding assessment were used to determine the MTD for stratum 1. Of 19 patients enrolled on stratum 1, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 17 patients were used to determine the MTD for stratum I.
reporting Status
POSTED
time Frame
4 weeks
title
Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 1
type
PRIMARY
unit Of Measure
mg/m^2/day

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

Preserved source evidence · Not medical advice