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NCT03306264 · OUTCOME

Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine

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
Litres
Interval / dispersion
Geometric Coefficient of Variation
Time frame
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 (each cycle= 28 days)

What was measured

Summarized data of Vz/F on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727.

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: 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to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.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: 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to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.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

GroupSource count
MDS or CMML: ASTX727127
AML: ASTX72778

Reported measurements

Decitabine: Day 1

Analysis denominator · Participants

GroupSource count
MDS or CMML: ASTX727127
AML: ASTX72778
Values in Litres · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
MDS or CMML: ASTX72758555.0Not reportedNot reportedNot reported
AML: ASTX72743460.4Not reportedNot reportedNot reported
Decitabine: Day 2

Analysis denominator · Participants

GroupSource count
MDS or CMML: ASTX727126
AML: ASTX72774
Values in Litres · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
MDS or CMML: ASTX72736959.0Not reportedNot reportedNot reported
AML: ASTX72733767.6Not reportedNot reportedNot reported
Decitabine: Day 5

Analysis denominator · Participants

GroupSource count
MDS or CMML: ASTX727123
AML: ASTX72775
Values in Litres · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
MDS or CMML: ASTX72741754.3Not reportedNot reportedNot reported
AML: ASTX72737368.9Not reportedNot reportedNot reported
Cedazuridine: Day 1

Analysis denominator · Participants

GroupSource count
MDS or CMML: ASTX727109
AML: ASTX72752
Values in Litres · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
MDS or CMML: ASTX72728050.9Not reportedNot reportedNot reported
AML: ASTX72727259.9Not reportedNot reportedNot reported
Cedazuridine: Day 2

Analysis denominator · Participants

GroupSource count
MDS or CMML: ASTX727118
AML: ASTX72756
Values in Litres · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
MDS or CMML: ASTX72729651.3Not reportedNot reportedNot reported
AML: ASTX72727849.8Not reportedNot reportedNot reported
Cedazuridine: Day 5

Analysis denominator · Participants

GroupSource count
MDS or CMML: ASTX7272
AML: ASTX7271
Values in Litres · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
MDS or CMML: ASTX72762.810.4Not reportedNot reportedNot reported
AML: ASTX727302NANot reportedNot reportedGeometric Coefficient of Variation could not be calculated as data for only one participant was available for analysis.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.0
        value
        585
      2. group Id
        OG001
        spread
        60.4
        value
        434
    denoms
    1. counts
      1. group Id
        OG000
        value
        127
      2. group Id
        OG001
        value
        78
      units
      Participants
    title
    Decitabine: Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.0
        value
        369
      2. group Id
        OG001
        spread
        67.6
        value
        337
    denoms
    1. counts
      1. group Id
        OG000
        value
        126
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Decitabine: Day 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.3
        value
        417
      2. group Id
        OG001
        spread
        68.9
        value
        373
    denoms
    1. counts
      1. group Id
        OG000
        value
        123
      2. group Id
        OG001
        value
        75
      units
      Participants
    title
    Decitabine: Day 5
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.9
        value
        280
      2. group Id
        OG001
        spread
        59.9
        value
        272
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    Cedazuridine: Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.3
        value
        296
      2. group Id
        OG001
        spread
        49.8
        value
        278
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Cedazuridine: Day 2
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.4
        value
        62.8
      2. comment
        Geometric Coefficient of Variation could not be calculated as data for only one participant was available for analysis.
        group Id
        OG001
        spread
        NA
        value
        302
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Cedazuridine: Day 5
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      78
    units
    Participants
description
Summarized data of Vz/F on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727.
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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
    OG000
    title
    MDS or CMML: ASTX727
  2. 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
    OG001
    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
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 (each cycle= 28 days)
title
Apparent Volume of Distribution (Vz/F) of Oral Decitabine and Cedazuridine
type
SECONDARY
unit Of Measure
Litres

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Preserved source evidence · Not medical advice