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NCT01077544 · OUTCOME

Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-12-29

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

Measure
GEOMETRIC_MEAN
Unit
L/h/m^2)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 8 - Cycle 1 day 28

What was measured

The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses

Analysis population: Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.

Groups in this outcome

Group 1

1 year to \< 10 years pediatric patients

Group 2

\>= 10 years to \<18 years pediatric patients

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

Analysis denominator · Participants

GroupSource count
Group 17
Group 27

Reported measurements

Source class 1
Values in L/h/m^2) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Group 115.35638.7Not reportedNot reportedNot reported
Group 215.92237.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.7
        value
        15.356
      2. group Id
        OG001
        spread
        37.0
        value
        15.922
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    1 year to \< 10 years pediatric patients
    id
    OG000
    title
    Group 1
  2. description
    \>= 10 years to \<18 years pediatric patients
    id
    OG001
    title
    Group 2
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.
reporting Status
POSTED
time Frame
Cycle 1 Day 8 - Cycle 1 day 28
title
Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)
type
PRIMARY
unit Of Measure
L/h/m^2)

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

Preserved source evidence · Not medical advice