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NCT02668653 · OUTCOME

Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max)

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) · Source last updated 2024-08-06

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

Measure
GEOMETRIC_MEAN
Unit
nanogram/milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)

What was measured

Css,max was assessed by population PK analysis during Cycle 1 of each phase.

Analysis population: PK Parameters were assessed in the PK Analyses set, which includes all participants in the Intent-to-Treat Analysis Set who received at least 1 dose of quizartinib and had at least 1 PK sample assessed.

Groups in this outcome

Quizartinib

Participants who were randomized to receive quizartinib treatment regimen.

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

Analysis denominator · Participants

GroupSource count
Quizartinib259

Reported measurements

Induction Period

Analysis denominator · Participants

GroupSource count
Quizartinib259
Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Quizartinib14071.2Not reportedNot reportedNot reported
Consolidation Period

Analysis denominator · Participants

GroupSource count
Quizartinib164
Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Quizartinib20463.5Not reportedNot reportedNot reported
Continuation Period - Dose 1

Analysis denominator · Participants

GroupSource count
Quizartinib115
Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Quizartinib26559.7Not reportedNot reportedNot reported
Continuation Period - Dose 2

Analysis denominator · Participants

GroupSource count
Quizartinib115
Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Quizartinib52959.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.2
        value
        140
    denoms
    1. counts
      1. group Id
        OG000
        value
        259
      units
      Participants
    title
    Induction Period
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.5
        value
        204
    denoms
    1. counts
      1. group Id
        OG000
        value
        164
      units
      Participants
    title
    Consolidation Period
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.7
        value
        265
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      units
      Participants
    title
    Continuation Period - Dose 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.7
        value
        529
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      units
      Participants
    title
    Continuation Period - Dose 2
denoms
  1. counts
    1. group Id
      OG000
      value
      259
    units
    Participants
description
Css,max was assessed by population PK analysis during Cycle 1 of each phase.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants who were randomized to receive quizartinib treatment regimen.
    id
    OG000
    title
    Quizartinib
param Type
GEOMETRIC_MEAN
population Description
PK Parameters were assessed in the PK Analyses set, which includes all participants in the Intent-to-Treat Analysis Set who received at least 1 dose of quizartinib and had at least 1 PK sample assessed.
reporting Status
POSTED
time Frame
Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)
title
Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max)
type
SECONDARY
unit Of Measure
nanogram/milliliter (ng/mL)

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

Preserved source evidence · Not medical advice