NCT01844765 · OUTCOME

Pharmacokinetics (PK): Steady State Concentration of Nilotinib in Imatinib/Dasatinib Resistant/Intolerant CML-CP Patients

Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. · Source last updated 2021-04-22

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 8

What was measured

PK was analyzed only when all patients has completed 12 cycles on treatment or discontinued the study treatment early.

Analysis population: Pharmacokinetics Analysis Set (PAS): All patients with at least one evaluable PK blood sample. Of the 32 patients included in the PAS, only 30 had evaluable Ctrough.

Groups in this outcome

Resistant/Intolerant Ph+ CML in CP

Patients resistant or intolerant to either imatinib or dasatinib

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
Resistant/Intolerant Ph+ CML in CP	30

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Resistant/Intolerant Ph+ CML in CP	1407.89	41.67	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
41.67
value
1407.89

denoms

counts
group Id
OG000
value
30
units
Participants

description

PK was analyzed only when all patients has completed 12 cycles on treatment or discontinued the study treatment early.

dispersion Type

Geometric Coefficient of Variation

groups

description
Patients resistant or intolerant to either imatinib or dasatinib
id
OG000
title
Resistant/Intolerant Ph+ CML in CP

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetics Analysis Set (PAS): All patients with at least one evaluable PK blood sample. Of the 32 patients included in the PAS, only 30 had evaluable Ctrough.

reporting Status

POSTED

time Frame

Cycle 1 Day 8

title

Pharmacokinetics (PK): Steady State Concentration of Nilotinib in Imatinib/Dasatinib Resistant/Intolerant CML-CP Patients

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice