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NCT02367456 · OUTCOME

Trough Plasma Concentration (Ctrough) of Glasdegib on Cycle 1 Day 15 and Cycle 2 Day 1 in the AML and MDS Cohorts

A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients · Source last updated 2024-01-19

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
Pre-dose and 1 and 4 hours post-dose on Cycle 1 Day 15 (C1D15) and Cycle 2 Day 1 (C2D1)

What was measured

Trough plasma concentration was defined as the estimated lowest concentration before next dose administration.

Analysis population: The PK concentration analysis set included all participants who received treatment and had at least 1 value of analyte concentration of glasdegib or azacitidine available. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = number of participants with evaluable results at the specific timepoint.

Groups in this outcome

AML Cohort

Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.

MDS Cohort

Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.

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

Analysis denominator · Participants

GroupSource count
AML Cohort30
MDS Cohort30

Reported measurements

C1D15

Analysis denominator · Participants

GroupSource count
AML Cohort25
MDS Cohort22
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
AML Cohort468.44088Not reportedNot reportedNot reported
MDS Cohort308.14495Not reportedNot reportedNot reported
C2D1

Analysis denominator · Participants

GroupSource count
AML Cohort17
MDS Cohort18
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
AML Cohort462.806110Not reportedNot reportedNot reported
MDS Cohort167.48352Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        88
        value
        468.440
      2. group Id
        OG001
        spread
        95
        value
        308.144
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    C1D15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        110
        value
        462.806
      2. group Id
        OG001
        spread
        52
        value
        167.483
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    C2D1
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Trough plasma concentration was defined as the estimated lowest concentration before next dose administration.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
    id
    OG000
    title
    AML Cohort
  2. description
    Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
    id
    OG001
    title
    MDS Cohort
param Type
GEOMETRIC_MEAN
population Description
The PK concentration analysis set included all participants who received treatment and had at least 1 value of analyte concentration of glasdegib or azacitidine available. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = number of participants with evaluable results at the specific timepoint.
reporting Status
POSTED
time Frame
Pre-dose and 1 and 4 hours post-dose on Cycle 1 Day 15 (C1D15) and Cycle 2 Day 1 (C2D1)
title
Trough Plasma Concentration (Ctrough) of Glasdegib on Cycle 1 Day 15 and Cycle 2 Day 1 in the AML and MDS Cohorts
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice