NCT02367456 · OUTCOME

Time to First Occurrence of Maximum Plasma Concentration (Tmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) 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: Pre-dose and 0.25, 1, 4, 6, 24 hours post-dose on Cycle 1 Day 7 and Cycle 1 Day 15

What was measured

Time to first occurrence of maximum plasma concentration of glasdegib dosed in combination with azacitidine (C1D7) and when dosed alone (C1D15) 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. 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

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

Group	Source count
Lead-in Cohort	12

Reported measurements

C1D7

Analysis denominator · Participants

Group	Source count
Lead-in Cohort	12

Values in hour · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Lead-in Cohort	1.050	Not reported	1.00	5.70	Not reported

C1D15

Analysis denominator · Participants

Group	Source count
Lead-in Cohort	9

Values in hour · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Lead-in Cohort	1.500	Not reported	1.00	6.02	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
5.70
value
1.050
denoms
counts
group Id
OG000
value
12
units
Participants
title
C1D7
categories
measurements
group Id
OG000
lower Limit
1.00
upper Limit
6.02
value
1.500
denoms
counts
group Id
OG000
value
9
units
Participants
title
C1D15

denoms

counts
group Id
OG000
value
12
units
Participants

description

dispersion Type

Full Range

groups

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. 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 0.25, 1, 4, 6, 24 hours post-dose on Cycle 1 Day 7 and Cycle 1 Day 15

title

Time to First Occurrence of Maximum Plasma Concentration (Tmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) 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