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NCT01189266 · OUTCOME

Maximum Tolerated Dose (MTD) of Vorinostat

Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma · Source last updated 2021-10-28

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

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Planned 7 weeks during chemoradiotherapy

What was measured

The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy

Analysis population: All patients enrolled on arm 1 and 2 who received at least 85% of the planned doses of radiation therapy and chemotherapy in the chemoradiotherapy portion of the study or who experienced DLT after after receiving at least one dose of chemoradio therapy and completing 7 weeks fo follow-up.

Groups in this outcome

All Phase 1 Study Participants

Arm 1, Phase 1 participants received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Arm 2, Phase 1 participants received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks).

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

Analysis denominator · Participants

GroupSource count
All Phase 1 Study Participants12

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Phase 1 Study Participants230Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        230
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy
groups
  1. description
    Arm 1, Phase 1 participants received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Arm 2, Phase 1 participants received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks).
    id
    OG000
    title
    All Phase 1 Study Participants
param Type
NUMBER
population Description
All patients enrolled on arm 1 and 2 who received at least 85% of the planned doses of radiation therapy and chemotherapy in the chemoradiotherapy portion of the study or who experienced DLT after after receiving at least one dose of chemoradio therapy and completing 7 weeks fo follow-up.
reporting Status
POSTED
time Frame
Planned 7 weeks during chemoradiotherapy
title
Maximum Tolerated Dose (MTD) of Vorinostat
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice