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NCT02717455 · OUTCOME

Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 2

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. For Stratum 2, non-progressed DIPG or H3K27M+ thalamic diffuse malignant glioma (DMG) patients who completed conventional radiation treatment were eligible. All patients enrolled on this stratum had DIPG tumors and were treated with the "3 times/week, every other week" schedule (1 course = 28 days).

Analysis population: Patients who were enrolled on stratum 2 and were evaluable for dose finding assessment were used to determine the MTD for stratum 2. Of 34 patients enrolled on stratum 2, 5 patients were not evaluable due to: receiving less than required dose of study drug (2), disease progression before active treatment (1), withdrawal/refusal prior to protocol therapy (1), and insufficient labs to monitor for dose-limiting toxicities (1). The remaining 29 patients were used to determine the MTD for stratum 2.

Groups in this outcome

Stratum 2

Non-progressed DIPG or H3K27M+ thalamic DMG patients who were treated with the "3 times/week, every other week" 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 229

Reported measurements

Source class 1
Values in mg/m^2/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 222Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    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. For Stratum 2, non-progressed DIPG or H3K27M+ thalamic diffuse malignant glioma (DMG) patients who completed conventional radiation treatment were eligible. All patients enrolled on this stratum had DIPG tumors and were treated with the "3 times/week, every other week" schedule (1 course = 28 days).
groups
  1. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients who were treated with the "3 times/week, every other week" schedule.
    id
    OG000
    title
    Stratum 2
param Type
NUMBER
population Description
Patients who were enrolled on stratum 2 and were evaluable for dose finding assessment were used to determine the MTD for stratum 2. Of 34 patients enrolled on stratum 2, 5 patients were not evaluable due to: receiving less than required dose of study drug (2), disease progression before active treatment (1), withdrawal/refusal prior to protocol therapy (1), and insufficient labs to monitor for dose-limiting toxicities (1). The remaining 29 patients were used to determine the MTD for stratum 2.
reporting Status
POSTED
time Frame
4 weeks
title
Maximum Tolerated Dose (MTD) of Panobinostat in Stratum 2
type
PRIMARY
unit Of Measure
mg/m^2/day

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

Preserved source evidence · Not medical advice