TriangleNCT03922100 · OUTCOME
Pharmacokinetic Parameter: Area Under the Concentration-time Curve to the Last Measurable Concentration (AUClast) and Area Under the Concentration-time Curve From Time Zero to 24 Hour (AUC0-24) of NMS-03592088
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- h·μM
- Interval / dispersion
- Standard Deviation
- Time frame
- Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
What was measured
Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)
Analysis population: Participants evaluable for PK analysis (treated participants were considered evaluable if they had sufficient baseline and on-study sampled material to provide interpretable results). The plasma PK of NMS-03592088 and 2 metabolites NMS-03593860 and NMS-03603422 were collected, and PK profile characterised. Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
Groups in this outcome
Phase 1, Schedule A: 20 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
Phase 1, Schedule A: 40 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 80 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 120 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 180 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 270 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 300 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule A: 360 mg
All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
Phase 1, Schedule B: 120 mg
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
Phase 1, Schedule B: 180 mg
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
Phase 1, Schedule B: 250 mg
All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
Phase 2, Schedule B: 360+150 mg
Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 3 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 10 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B: 360+150 mg | 15 |
Reported measurements
AUClast: Day 1
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 2 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 9 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B: 360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0.0923 | 19.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0.244 | 32.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0.402 | 22.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0.551 | 34.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 1.43 | 66.7 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 2.23 | 54.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 2.17 | 61.2 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 3.44 | 78.6 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 1.09 | 61.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 1.33 | 27.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 2.12 | 60.8 | Not reported | Not reported | Not reported |
| Phase 2, Schedule B: 360+150 mg | 0.412 | 46.4 | Not reported | Not reported | Not reported |
AUClast: Day 21
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 3 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 10 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 0 |
| Phase 1, Schedule B: 180 mg | 0 |
| Phase 1, Schedule B: 250 mg | 0 |
| Phase 2, Schedule B: 360+150 mg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 4.10 | 53.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 3.96 | 71.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 6.31 | 29.0 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 6.98 | 35.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 13.4 | 54.4 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 34.5 | 28.2 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 31.4 | 59.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 23.7 | 80.1 | Not reported | Not reported | Not reported |
AUClast: Day 28
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 0 |
| Phase 1, Schedule A: 40 mg | 0 |
| Phase 1, Schedule A: 80 mg | 0 |
| Phase 1, Schedule A: 120 mg | 0 |
| Phase 1, Schedule A: 180 mg | 0 |
| Phase 1, Schedule A: 270 mg | 0 |
| Phase 1, Schedule A: 300 mg | 0 |
| Phase 1, Schedule A: 360 mg | 0 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B: 360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule B: 120 mg | 4.39 | 36.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 6.67 | 48.7 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 9.09 | 56.5 | Not reported | Not reported | Not reported |
| Phase 2, Schedule B: 360+150 mg | 2.84 | 69.9 | Not reported | Not reported | Not reported |
AUC0-24: Day 1
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 2 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 9 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B: 360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0.0923 | 19.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0.244 | 32.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0.402 | 22.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0.551 | 34.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 1.42 | 65.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 2.23 | 54.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 2.17 | 61.2 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 3.44 | 78.6 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 1.09 | 61.5 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 1.33 | 27.9 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 2.12 | 61.1 | Not reported | Not reported | Not reported |
| Phase 2, Schedule B: 360+150 mg | 0.412 | 46.4 | Not reported | Not reported | Not reported |
AUC0-24: Day 21
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 3 |
| Phase 1, Schedule A: 40 mg | 3 |
| Phase 1, Schedule A: 80 mg | 3 |
| Phase 1, Schedule A: 120 mg | 3 |
| Phase 1, Schedule A: 180 mg | 3 |
| Phase 1, Schedule A: 270 mg | 4 |
| Phase 1, Schedule A: 300 mg | 10 |
| Phase 1, Schedule A: 360 mg | 3 |
| Phase 1, Schedule B: 120 mg | 0 |
| Phase 1, Schedule B: 180 mg | 0 |
| Phase 1, Schedule B: 250 mg | 0 |
| Phase 2, Schedule B: 360+150 mg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 1.02 | 41.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0.941 | 56.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 1.78 | 30.2 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 2.14 | 32.0 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 4.80 | 37.3 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 10.1 | 27.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 8.37 | 50.4 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 8.43 | 54.6 | Not reported | Not reported | Not reported |
AUC0-24: Day 28
| Group | Source count |
|---|---|
| Phase 1, Schedule A: 20 mg | 0 |
| Phase 1, Schedule A: 40 mg | 0 |
| Phase 1, Schedule A: 80 mg | 0 |
| Phase 1, Schedule A: 120 mg | 0 |
| Phase 1, Schedule A: 180 mg | 0 |
| Phase 1, Schedule A: 270 mg | 0 |
| Phase 1, Schedule A: 300 mg | 0 |
| Phase 1, Schedule A: 360 mg | 0 |
| Phase 1, Schedule B: 120 mg | 4 |
| Phase 1, Schedule B: 180 mg | 6 |
| Phase 1, Schedule B: 250 mg | 4 |
| Phase 2, Schedule B: 360+150 mg | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule B: 120 mg | 4.39 | 36.1 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 6.65 | 48.2 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 9.07 | 56.2 | Not reported | Not reported | Not reported |
| Phase 2, Schedule B: 360+150 mg | 2.83 | 69.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.9
- value
- 0.0923
- group Id
- OG001
- spread
- 32.9
- value
- 0.244
- group Id
- OG002
- spread
- 22.9
- value
- 0.402
- group Id
- OG003
- spread
- 34.1
- value
- 0.551
- group Id
- OG004
- spread
- 66.7
- value
- 1.43
- group Id
- OG005
- spread
- 54.1
- value
- 2.23
- group Id
- OG006
- spread
- 61.2
- value
- 2.17
- group Id
- OG007
- spread
- 78.6
- value
- 3.44
- group Id
- OG008
- spread
- 61.5
- value
- 1.09
- group Id
- OG009
- spread
- 27.9
- value
- 1.33
- group Id
- OG010
- spread
- 60.8
- value
- 2.12
- group Id
- OG011
- spread
- 46.4
- value
- 0.412
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- AUClast: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 53.3
- value
- 4.10
- group Id
- OG001
- spread
- 71.9
- value
- 3.96
- group Id
- OG002
- spread
- 29.0
- value
- 6.31
- group Id
- OG003
- spread
- 35.3
- value
- 6.98
- group Id
- OG004
- spread
- 54.4
- value
- 13.4
- group Id
- OG005
- spread
- 28.2
- value
- 34.5
- group Id
- OG006
- spread
- 59.1
- value
- 31.4
- group Id
- OG007
- spread
- 80.1
- value
- 23.7
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- AUClast: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 36.1
- value
- 4.39
- group Id
- OG009
- spread
- 48.7
- value
- 6.67
- group Id
- OG010
- spread
- 56.5
- value
- 9.09
- group Id
- OG011
- spread
- 69.9
- value
- 2.84
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- AUClast: Day 28
- categories
- measurements
- group Id
- OG000
- spread
- 19.9
- value
- 0.0923
- group Id
- OG001
- spread
- 32.9
- value
- 0.244
- group Id
- OG002
- spread
- 22.9
- value
- 0.402
- group Id
- OG003
- spread
- 34.1
- value
- 0.551
- group Id
- OG004
- spread
- 65.9
- value
- 1.42
- group Id
- OG005
- spread
- 54.1
- value
- 2.23
- group Id
- OG006
- spread
- 61.2
- value
- 2.17
- group Id
- OG007
- spread
- 78.6
- value
- 3.44
- group Id
- OG008
- spread
- 61.5
- value
- 1.09
- group Id
- OG009
- spread
- 27.9
- value
- 1.33
- group Id
- OG010
- spread
- 61.1
- value
- 2.12
- group Id
- OG011
- spread
- 46.4
- value
- 0.412
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- AUC0-24: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 41.3
- value
- 1.02
- group Id
- OG001
- spread
- 56.3
- value
- 0.941
- group Id
- OG002
- spread
- 30.2
- value
- 1.78
- group Id
- OG003
- spread
- 32.0
- value
- 2.14
- group Id
- OG004
- spread
- 37.3
- value
- 4.80
- group Id
- OG005
- spread
- 27.1
- value
- 10.1
- group Id
- OG006
- spread
- 50.4
- value
- 8.37
- group Id
- OG007
- spread
- 54.6
- value
- 8.43
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- AUC0-24: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 36.1
- value
- 4.39
- group Id
- OG009
- spread
- 48.2
- value
- 6.65
- group Id
- OG010
- spread
- 56.2
- value
- 9.07
- group Id
- OG011
- spread
- 69.8
- value
- 2.83
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- title
- AUC0-24: Day 28
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 15
- units
- Participants
- description
- Plasma samples were collected and used for pharmacokinetics (PK) assessments. Mean values of PK parameters are presented with the coefficient of variation (CV%)
- dispersion Type
- Standard Deviation
- groups
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- OG000
- title
- Phase 1, Schedule A: 20 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG001
- title
- Phase 1, Schedule A: 40 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG002
- title
- Phase 1, Schedule A: 80 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG003
- title
- Phase 1, Schedule A: 120 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG004
- title
- Phase 1, Schedule A: 180 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG005
- title
- Phase 1, Schedule A: 270 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG006
- title
- Phase 1, Schedule A: 300 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- OG007
- title
- Phase 1, Schedule A: 360 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
- id
- OG008
- title
- Phase 1, Schedule B: 120 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
- id
- OG009
- title
- Phase 1, Schedule B: 180 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
- id
- OG010
- title
- Phase 1, Schedule B: 250 mg
- description
- Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards
- id
- OG011
- title
- Phase 2, Schedule B: 360+150 mg
- param Type
- MEAN
- population Description
- Participants evaluable for PK analysis (treated participants were considered evaluable if they had sufficient baseline and on-study sampled material to provide interpretable results). The plasma PK of NMS-03592088 and 2 metabolites NMS-03593860 and NMS-03603422 were collected, and PK profile characterised. Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
- reporting Status
- POSTED
- time Frame
- Schedule A: Day 1 and Day 21 Schedule B: Day 1 and Day 28
- title
- Pharmacokinetic Parameter: Area Under the Concentration-time Curve to the Last Measurable Concentration (AUClast) and Area Under the Concentration-time Curve From Time Zero to 24 Hour (AUC0-24) of NMS-03592088
- type
- SECONDARY
- unit Of Measure
- h·μM
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Preserved source evidence · Not medical advice