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NCT02367456 · OUTCOME

Tmax of Azacitidine Dosed in Combination With Glasdegib (C1D7) and When Dosed Alone (C1D1) in the Lead-in Cohort

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
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 1, predose and 0.25, 0.5, 1, 2, 6 hours postdose on Cycle 1 Day 7

What was measured

Time to first occurrence of maximum plasma concentration of azacitidine dosed in combination with glasdegib (C1D7) and when dosed alone (C1D1) in the Lead-in Cohort was estimated using non-compartmental analysis.

Analysis population: The PK parameter analysis set included all participants who received study treatment and had at least 1 of the PK parameters of interest.

Groups in this outcome

Lead-in Cohort

Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.

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

Analysis denominator · Participants

GroupSource count
Lead-in Cohort12

Reported measurements

C1D1
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lead-in Cohort0.5000Not reported0.0001.00Not reported
C1D7
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lead-in Cohort0.5000Not reported0.2501.08Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.000
        upper Limit
        1.00
        value
        0.5000
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.250
        upper Limit
        1.08
        value
        0.5000
    title
    C1D7
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Time to first occurrence of maximum plasma concentration of azacitidine dosed in combination with glasdegib (C1D7) and when dosed alone (C1D1) in the Lead-in Cohort was estimated using non-compartmental analysis.
dispersion Type
Full Range
groups
  1. description
    Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
    id
    OG000
    title
    Lead-in Cohort
param Type
MEDIAN
population Description
The PK parameter analysis set included all participants who received study treatment and had at least 1 of the PK parameters of interest.
reporting Status
POSTED
time Frame
0.25, 0.5, 1, 2, 6 hours post-dose on Cycle 1 Day 1, predose and 0.25, 0.5, 1, 2, 6 hours postdose on Cycle 1 Day 7
title
Tmax of Azacitidine Dosed in Combination With Glasdegib (C1D7) and When Dosed Alone (C1D1) in the Lead-in Cohort
type
SECONDARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice