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NCT00602667 · OUTCOME

Topotecan Apparent Oral Clearance in Maintenance Chemotherapy

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
L/h
Interval / dispersion
Full Range
Time frame
Pre-dose, 0.25, 1.5 and 6 hours post-dose

What was measured

Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis.

Analysis population: Eligible patients who received oral topotecan during maintenance therapy cycle A1 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 Group18
Intermediate-Risk Group33
High-Risk Group10

Reported measurements

Source class 1
Values in L/h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Low-Risk Group41.4Not reported12.354.6Not reported
Intermediate-Risk Group41.0Not reported24.462.7Not reported
High-Risk Group44.6Not reported18.157.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.3
        upper Limit
        54.6
        value
        41.4
      2. group Id
        OG001
        lower Limit
        24.4
        upper Limit
        62.7
        value
        41.0
      3. group Id
        OG002
        lower Limit
        18.1
        upper Limit
        57.0
        value
        44.6
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      10
    units
    Participants
description
Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance 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 topotecan during maintenance therapy cycle A1 and had samples collected for PK analysis.
reporting Status
POSTED
time Frame
Pre-dose, 0.25, 1.5 and 6 hours post-dose
title
Topotecan Apparent Oral Clearance in Maintenance Chemotherapy
type
SECONDARY
unit Of Measure
L/h

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

Preserved source evidence · Not medical advice