NCT01077544 · OUTCOME

Summary of Nilotinib Non-compartmental PK Parameters: Cmax

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: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
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 ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Group 1	405.111	42.5	Not reported	Not reported	Not reported
Group 2	402.715	35.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
42.5
value
405.111
group Id
OG001
spread
35.2
value
402.715

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

Geometric Coefficient of Variation

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

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 1

title

Summary of Nilotinib Non-compartmental PK Parameters: Cmax

type

PRIMARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice