NCT03306264 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
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
- nanogram per milliliter (ng/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
Summarized data of Cmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Cmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine.
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to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.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 | 122 |
|---|
| MDS or CMML: ASTX727 | 128 |
|---|
| AML: IV Decitabine | 72 |
|---|
| AML: ASTX727 | 79 |
|---|
Reported measurements
Decitabine: Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 122 |
|---|
| MDS or CMML: ASTX727 | 128 |
|---|
| AML: IV Decitabine | 72 |
|---|
| AML: ASTX727 | 78 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: IV Decitabine | 184 | 48.1 | Not reported | Not reported | Not reported |
|---|
| MDS or CMML: ASTX727 | 83.1 | 66.1 | Not reported | Not reported | Not reported |
|---|
| AML: IV Decitabine | 187 | 64.7 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 85.9 | 56.6 | Not reported | Not reported | Not reported |
|---|
Decitabine: Day 2
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 0 |
|---|
| MDS or CMML: ASTX727 | 128 |
|---|
| AML: IV Decitabine | 0 |
|---|
| AML: ASTX727 | 76 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: ASTX727 | 145 | 54.7 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 139 | 58.5 | Not reported | Not reported | Not reported |
|---|
Decitabine: Day 5
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 122 |
|---|
| MDS or CMML: ASTX727 | 124 |
|---|
| AML: IV Decitabine | 70 |
|---|
| AML: ASTX727 | 76 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: IV Decitabine | 180 | 49.2 | Not reported | Not reported | Not reported |
|---|
| MDS or CMML: ASTX727 | 140 | 62.8 | Not reported | Not reported | Not reported |
|---|
| AML: IV Decitabine | 192 | 62.4 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 139 | 62.7 | Not reported | Not reported | Not reported |
|---|
Cedazuridine: Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 0 |
|---|
| MDS or CMML: ASTX727 | 128 |
|---|
| AML: IV Decitabine | 0 |
|---|
| AML: ASTX727 | 78 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: ASTX727 | 321 | 53.8 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 313 | 47.7 | Not reported | Not reported | Not reported |
|---|
Cedazuridine: Day 2
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 0 |
|---|
| MDS or CMML: ASTX727 | 128 |
|---|
| AML: IV Decitabine | 0 |
|---|
| AML: ASTX727 | 78 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: ASTX727 | 349 | 49.1 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 343 | 43.4 | Not reported | Not reported | Not reported |
|---|
Cedazuridine: Day 5
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 0 |
|---|
| MDS or CMML: ASTX727 | 126 |
|---|
| AML: IV Decitabine | 0 |
|---|
| AML: ASTX727 | 77 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: ASTX727 | 371 | 51.8 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 350 | 42.7 | Not reported | Not reported | Not reported |
|---|
Cedazuridine-epimer: Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 0 |
|---|
| MDS or CMML: ASTX727 | 128 |
|---|
| AML: IV Decitabine | 0 |
|---|
| AML: ASTX727 | 79 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: ASTX727 | 150 | 65.7 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 182 | 60.0 | Not reported | Not reported | Not reported |
|---|
Cedazuridine-epimer: Day 2
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 0 |
|---|
| MDS or CMML: ASTX727 | 128 |
|---|
| AML: IV Decitabine | 0 |
|---|
| AML: ASTX727 | 78 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: ASTX727 | 155 | 64.6 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 204 | 59.2 | Not reported | Not reported | Not reported |
|---|
Cedazuridine-epimer: Day 5
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS or CMML: IV Decitabine | 0 |
|---|
| MDS or CMML: ASTX727 | 126 |
|---|
| AML: IV Decitabine | 0 |
|---|
| AML: ASTX727 | 77 |
|---|
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS or CMML: ASTX727 | 169 | 65.9 | Not reported | Not reported | Not reported |
|---|
| AML: ASTX727 | 191 | 58.4 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 48.1
- value
- 184
- group Id
- OG001
- spread
- 66.1
- value
- 83.1
- group Id
- OG002
- spread
- 64.7
- value
- 187
- group Id
- OG003
- spread
- 56.6
- value
- 85.9
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 72
- group Id
- OG003
- value
- 78
- units
- Participants
- title
- Decitabine: Day 1
- categories
- measurements
- group Id
- OG001
- spread
- 54.7
- value
- 145
- group Id
- OG003
- spread
- 58.5
- value
- 139
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 76
- units
- Participants
- title
- Decitabine: Day 2
- categories
- measurements
- group Id
- OG000
- spread
- 49.2
- value
- 180
- group Id
- OG001
- spread
- 62.8
- value
- 140
- group Id
- OG002
- spread
- 62.4
- value
- 192
- group Id
- OG003
- spread
- 62.7
- value
- 139
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 124
- group Id
- OG002
- value
- 70
- group Id
- OG003
- value
- 76
- units
- Participants
- title
- Decitabine: Day 5
- categories
- measurements
- group Id
- OG001
- spread
- 53.8
- value
- 321
- group Id
- OG003
- spread
- 47.7
- value
- 313
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 78
- units
- Participants
- title
- Cedazuridine: Day 1
- categories
- measurements
- group Id
- OG001
- spread
- 49.1
- value
- 349
- group Id
- OG003
- spread
- 43.4
- value
- 343
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 78
- units
- Participants
- title
- Cedazuridine: Day 2
- categories
- measurements
- group Id
- OG001
- spread
- 51.8
- value
- 371
- group Id
- OG003
- spread
- 42.7
- value
- 350
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 126
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 77
- units
- Participants
- title
- Cedazuridine: Day 5
- categories
- measurements
- group Id
- OG001
- spread
- 65.7
- value
- 150
- group Id
- OG003
- spread
- 60.0
- value
- 182
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 79
- units
- Participants
- title
- Cedazuridine-epimer: Day 1
- categories
- measurements
- group Id
- OG001
- spread
- 64.6
- value
- 155
- group Id
- OG003
- spread
- 59.2
- value
- 204
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 78
- units
- Participants
- title
- Cedazuridine-epimer: Day 2
- categories
- measurements
- group Id
- OG001
- spread
- 65.9
- value
- 169
- group Id
- OG003
- spread
- 58.4
- value
- 191
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 126
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 77
- units
- Participants
- title
- Cedazuridine-epimer: Day 5
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 72
- group Id
- OG003
- value
- 79
- units
- Participants
- description
- Summarized data of Cmax on Day 1, 2 and 5 respectively for Cycle 1 and 2 has been reported for ASTX727. Similarly, summarized data of Cmax on Day 1 and 5 respectively for Cycle 1 and 2 has been reported for IV Decitabine.
- 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
- Maximum Observed Plasma Concentration (Cmax) of Decitabine, Cedazuridine, and Cedazuridine-epimer
- type
- SECONDARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
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