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NCT00602667 · OUTCOME

OSI-420 AUC0-24h

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma · Source last updated 2026-05-19

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

Measure
MEDIAN
Unit
µmol·h/L
Interval / dispersion
Full Range
Time frame
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

What was measured

Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.

Analysis population: Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.

Groups in this outcome

Low-Risk Group

Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma

Intermediate-Risk Group

Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease

High-Risk Group

Patients with central nervous system (CNS) metastatic disease

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

Analysis denominator · Participants

GroupSource count
Low-Risk Group10
Intermediate-Risk Group11
High-Risk Group3

Reported measurements

Source class 1
Values in µmol·h/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Low-Risk Group2.17Not reported0.735.98Not reported
Intermediate-Risk Group1.81Not reported1.176.97Not reported
High-Risk Group1.62Not reported1.252.93Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.73
        upper Limit
        5.98
        value
        2.17
      2. group Id
        OG001
        lower Limit
        1.17
        upper Limit
        6.97
        value
        1.81
      3. group Id
        OG002
        lower Limit
        1.25
        upper Limit
        2.93
        value
        1.62
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      3
    units
    Participants
description
Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.
dispersion Type
Full Range
groups
  1. description
    Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
    id
    OG000
    title
    Low-Risk Group
  2. description
    Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
    id
    OG001
    title
    Intermediate-Risk Group
  3. description
    Patients with central nervous system (CNS) metastatic disease
    id
    OG002
    title
    High-Risk Group
param Type
MEDIAN
population Description
Eligible patients who received oral erlotinib during maintenance therapy cycle B2 and had samples collected for PK analysis.
reporting Status
POSTED
time Frame
Pre-dose, 1, 2, 4, 8, and 24 hours post-dose
title
OSI-420 AUC0-24h
type
SECONDARY
unit Of Measure
µmol·h/L

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice