NCT01077544 · OUTCOME

Summary of Nilotinib Non-compartmental PK Parameters: Tmax

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: MEDIAN
Unit: h
Interval / dispersion: Full Range
Time frame: Cycle 1 Day 1

What was measured

The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.

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

Group	Source count
Group 1	7
Group 2	7

Reported measurements

Source class 1

Values in h · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Group 1	2.000	163.1050	1.02	7.08	Not reported
Group 2	3.000	140.8314	2.00	7.88	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.02
spread
163.1050
upper Limit
7.08
value
2.000
group Id
OG001
lower Limit
2.00
spread
140.8314
upper Limit
7.88
value
3.000

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
7
units
Participants

description

The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.

dispersion Type

Full Range

groups

description
1 year to \< 10 years pediatric patients
id
OG000
title
Group 1
description
\>= 10 years to \<18 years pediatric patients
id
OG001
title
Group 2

param Type

MEDIAN

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 1

title

Summary of Nilotinib Non-compartmental PK Parameters: Tmax

type

PRIMARY

unit Of Measure

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

Preserved source evidence · Not medical advice