NCT00652626 · OUTCOME

Maximum Plasma Concentration of Azacitidine (Cmax)

Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function · Source last updated 2019-11-19

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: Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose

What was measured

The maximum observed plasma concentration of azacitidine after a single dose on Day 1.

Analysis population: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.

Groups in this outcome

Azacitidine 25 mg/m^2

Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.

Azacitidine 50 mg/m^2

Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.

Azacitidine 75 mg/m^2

Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.

Azacitidine 100 mg/m^2

Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.

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
Azacitidine 25 mg/m^2	5
Azacitidine 50 mg/m^2	5
Azacitidine 75 mg/m^2	6
Azacitidine 100 mg/m^2	5

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Azacitidine 25 mg/m^2	293.38	34.11	Not reported	Not reported	Not reported
Azacitidine 50 mg/m^2	749.04	61.03	Not reported	Not reported	Not reported
Azacitidine 75 mg/m^2	745.50	57.90	Not reported	Not reported	Not reported
Azacitidine 100 mg/m^2	1261.96	39.19	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
66.3
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
245.7
estimate Comment
Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.
group Description
Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
param Type
Ratio (%) of Geometric Means
param Value
127.7
ci Lower Limit
45.3
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
158.5
estimate Comment
Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.
group Description
Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
param Type
Ratio (%) of Geometric Means
param Value
84.7
ci Lower Limit
55.9
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
207.0
estimate Comment
Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.
group Description
Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
param Type
Ratio (%) of Geometric Means
param Value
107.5

Complete source fields

analyses

ci Lower Limit
66.3
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
245.7
estimate Comment
Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.
group Description
Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
param Type
Ratio (%) of Geometric Means
param Value
127.7
ci Lower Limit
45.3
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
158.5
estimate Comment
Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.
group Description
Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
param Type
Ratio (%) of Geometric Means
param Value
84.7
ci Lower Limit
55.9
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
207.0
estimate Comment
Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.
group Description
Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
param Type
Ratio (%) of Geometric Means
param Value
107.5

classes

categories
measurements
group Id
OG000
spread
34.11
value
293.38
group Id
OG001
spread
61.03
value
749.04
group Id
OG002
spread
57.90
value
745.50
group Id
OG003
spread
39.19
value
1261.96

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
6
group Id
OG003
value
5
units
Participants

description

The maximum observed plasma concentration of azacitidine after a single dose on Day 1.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
id
OG000
title
Azacitidine 25 mg/m^2
description
Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
id
OG001
title
Azacitidine 50 mg/m^2
description
Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
id
OG002
title
Azacitidine 75 mg/m^2
description
Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
id
OG003
title
Azacitidine 100 mg/m^2

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.

reporting Status

POSTED

time Frame

Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose

title

Maximum Plasma Concentration of Azacitidine (Cmax)

type

PRIMARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice