NCT03306264 · OUTCOME

Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine

Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML · Source last updated 2024-08-27

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

Measure: GEOMETRIC_MEAN
Unit: nanograms*hours per millilitres(ng*h/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days)

What was measured

AUC0-inf was calculated using the formula AUClast + (Clast / λZ), where Clast is the last quantifiable concentration and λZ is the elimination rate constant. AUC0-inf will be calculated using the linear up-log down method. Summarized data has been reported for cycle 1 and 2.

Analysis population: Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

Groups in this outcome

MDS or CMML: IV Decitabine

Participants with MDS or CMML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).

MDS or CMML: ASTX727

Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.

AML: IV Decitabine

Participants with AML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).

AML: ASTX727

Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.

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
MDS or CMML: IV Decitabine	119
MDS or CMML: ASTX727	127
AML: IV Decitabine	70
AML: ASTX727	78

Reported measurements

Day 1

Analysis denominator · Participants

Group	Source count
MDS or CMML: IV Decitabine	119
MDS or CMML: ASTX727	127
AML: IV Decitabine	70
AML: ASTX727	78

Values in nanograms*hours per millilitres(ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MDS or CMML: IV Decitabine	174	40.8	Not reported	Not reported	Not reported
MDS or CMML: ASTX727	102	54.8	Not reported	Not reported	Not reported
AML: IV Decitabine	175	54.9	Not reported	Not reported	Not reported
AML: ASTX727	118	54.4	Not reported	Not reported	Not reported

Day 2

Analysis denominator · Participants

Group	Source count
MDS or CMML: IV Decitabine	0
MDS or CMML: ASTX727	126
AML: IV Decitabine	0
AML: ASTX727	74

Values in nanograms*hours per millilitres(ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MDS or CMML: ASTX727	186	55.3	Not reported	Not reported	Not reported
AML: ASTX727	193	59.6	Not reported	Not reported	Not reported

Day 5

Analysis denominator · Participants

Group	Source count
MDS or CMML: IV Decitabine	119
MDS or CMML: ASTX727	123
AML: IV Decitabine	70
AML: ASTX727	75

Values in nanograms*hours per millilitres(ng*h/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MDS or CMML: IV Decitabine	170	41.7	Not reported	Not reported	Not reported
MDS or CMML: ASTX727	178	52.7	Not reported	Not reported	Not reported
AML: IV Decitabine	181	58.1	Not reported	Not reported	Not reported
AML: ASTX727	187	57.1	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
40.8
value
174
group Id
OG001
spread
54.8
value
102
group Id
OG002
spread
54.9
value
175
group Id
OG003
spread
54.4
value
118
denoms
counts
group Id
OG000
value
119
group Id
OG001
value
127
group Id
OG002
value
70
group Id
OG003
value
78
units
Participants
title
Day 1
categories
measurements
group Id
OG001
spread
55.3
value
186
group Id
OG003
spread
59.6
value
193
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
126
group Id
OG002
value
0
group Id
OG003
value
74
units
Participants
title
Day 2
categories
measurements
group Id
OG000
spread
41.7
value
170
group Id
OG001
spread
52.7
value
178
group Id
OG002
spread
58.1
value
181
group Id
OG003
spread
57.1
value
187
denoms
counts
group Id
OG000
value
119
group Id
OG001
value
123
group Id
OG002
value
70
group Id
OG003
value
75
units
Participants
title
Day 5

denoms

counts
group Id
OG000
value
119
group Id
OG001
value
127
group Id
OG002
value
70
group Id
OG003
value
78
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants with MDS or CMML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).
id
OG000
title
MDS or CMML: IV Decitabine
description
Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
id
OG001
title
MDS or CMML: ASTX727
description
Participants with AML received decitabine 20 mg/m\^2 IV injection, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days).
id
OG002
title
AML: IV Decitabine
description
Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, given by mouth, once daily, on Days 1 to 5 in cycle 1 or 2 (each cycle = 28 days). From cycle 3, participants received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
id
OG003
title
AML: ASTX727

param Type

GEOMETRIC_MEAN

population Description

Overall PK Analysis Set included participants not included in Primary Endpoint PK Analysis Set, received any amount of study treatment, complied with protocol sufficiently to ensure PK samples were collected, provided sufficient samples to measure available plasma concentrations for decitabine. Overall number of participants analyzed:Number of participants evaluable for this outcome measure. Number analyzed:Number of participants evaluable for this outcome measure at specified time point.

reporting Status

POSTED

time Frame

ASTX727: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose on Days 1, 2 and 5 of Cycle 1 and 2; Decitabine: Pre-dose, 0.25, 0.5, 1, 1.08, 1.5, 2, 3, 4, 6, 8 hours post-dose on Days 1 and 5 of Cycle 1 and 2 (each cycle= 28 days)

title

Area Under the Curve From 0 to Infinity (AUC0-inf) After Treatment With ASTX727 And IV Decitabine

type

SECONDARY

unit Of Measure

nanograms*hours per millilitres(ng*h/mL)

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Preserved source evidence · Not medical advice