NCT03922100 · OUTCOME
Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax), Last Measurable Concentration (Clast), and Average Concentration (Cavg) of NMS-03592088
Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML · Source last updated 2026-03-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- 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 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 120 mg 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 270 mg 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| 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
Cmax: Day 1
Analysis denominator · Participants
| 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 | 3 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 0.00469 | 12.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 0.0174 | 19.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 0.0262 | 33.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 0.0388 | 53.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 0.118 | 43.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 0.211 | 84.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 0.207 | 55.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 0.240 | 79.8 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 120 mg | 0.0907 | 82.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 0.124 | 42.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 0.183 | 51.1 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 0.0995 | 43.9 | Not reported | Not reported | Not reported |
|---|
Cmax: Day 21
Analysis denominator · Participants
| 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 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 0.0523 | 52.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 0.0526 | 32.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 0.0896 | 22.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 0.125 | 45.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 0.320 | 64.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 0.553 | 41.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 0.444 | 50.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 0.467 | 40.9 | Not reported | Not reported | Not reported |
|---|
Cmax: Day 28
Analysis denominator · Participants
| 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 | 3 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule B: 120 mg | 0.266 | 42.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 0.354 | 46.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 0.462 | 54.4 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 0.168 | 37.7 | Not reported | Not reported | Not reported |
|---|
Clast: Day 1
Analysis denominator · Participants
| 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 | 3 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 0.00363 | 38.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 0.00819 | 55.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 0.0132 | 19.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 0.0188 | 45.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 0.0309 | 52.3 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 0.0568 | 46.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 0.137 | 68.8 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 0.0930 | 75.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 120 mg | 0.0296 | 37.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 0.0536 | 79.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 0.0957 | 19.7 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 0.0816 | 43.6 | Not reported | Not reported | Not reported |
|---|
Clast: Day 21
Analysis denominator · Participants
| 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 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 0.0151 | 59.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 0.00902 | 102 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 0.0199 | 77.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 0.0230 | 81.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 0.0548 | 48.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 0.0876 | 20.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 0.0831 | 86.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 0.215 | 80.9 | Not reported | Not reported | Not reported |
|---|
Clast: Day 28
Analysis denominator · Participants
| 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 | 3 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule B: 120 mg | 0.141 | 39.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 0.293 | 53.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 0.322 | 53.3 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 0.116 | 20.3 | Not reported | Not reported | Not reported |
|---|
Cavg: Day 1
Analysis denominator · Participants
| 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 | 3 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 0.00385 | 19.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 0.0102 | 32.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 0.0168 | 22.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 0.0230 | 34.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 0.0591 | 65.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 0.0931 | 54.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 0.0905 | 61.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 0.143 | 78.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 120 mg | 0.0455 | 61.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 0.0554 | 27.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 0.0883 | 61.1 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 0.0172 | 46.4 | Not reported | Not reported | Not reported |
|---|
Cavg: Day 21
Analysis denominator · Participants
| 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 | 9 |
|---|
| 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 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 0.0423 | 41.3 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 0.0392 | 56.3 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 0.0740 | 30.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 0.0890 | 32.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 0.200 | 37.3 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 0.421 | 27.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 0.349 | 50.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 0.351 | 54.6 | Not reported | Not reported | Not reported |
|---|
Cavg: Day 28
Analysis denominator · Participants
| 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 | 3 |
|---|
Values in μM · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule B: 120 mg | 0.183 | 36.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 0.277 | 48.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 0.378 | 56.2 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 0.118 | 69.8 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.9
- value
- 0.00469
- group Id
- OG001
- spread
- 19.1
- value
- 0.0174
- group Id
- OG002
- spread
- 33.6
- value
- 0.0262
- group Id
- OG003
- spread
- 53.1
- value
- 0.0388
- group Id
- OG004
- spread
- 43.9
- value
- 0.118
- group Id
- OG005
- spread
- 84.2
- value
- 0.211
- group Id
- OG006
- spread
- 55.5
- value
- 0.207
- group Id
- OG007
- spread
- 79.8
- value
- 0.240
- group Id
- OG008
- spread
- 82.4
- value
- 0.0907
- group Id
- OG009
- spread
- 42.9
- value
- 0.124
- group Id
- OG010
- spread
- 51.1
- value
- 0.183
- group Id
- OG011
- spread
- 43.9
- value
- 0.0995
- 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
- 3
- units
- Participants
- title
- Cmax: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 52.5
- value
- 0.0523
- group Id
- OG001
- spread
- 32.4
- value
- 0.0526
- group Id
- OG002
- spread
- 22.6
- value
- 0.0896
- group Id
- OG003
- spread
- 45.9
- value
- 0.125
- group Id
- OG004
- spread
- 64.0
- value
- 0.320
- group Id
- OG005
- spread
- 41.9
- value
- 0.553
- group Id
- OG006
- spread
- 50.6
- value
- 0.444
- group Id
- OG007
- spread
- 40.9
- value
- 0.467
- 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
- Cmax: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 42.0
- value
- 0.266
- group Id
- OG009
- spread
- 46.5
- value
- 0.354
- group Id
- OG010
- spread
- 54.4
- value
- 0.462
- group Id
- OG011
- spread
- 37.7
- value
- 0.168
- 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
- 3
- units
- Participants
- title
- Cmax: Day 28
- categories
- measurements
- group Id
- OG000
- spread
- 38.2
- value
- 0.00363
- group Id
- OG001
- spread
- 55.5
- value
- 0.00819
- group Id
- OG002
- spread
- 19.0
- value
- 0.0132
- group Id
- OG003
- spread
- 45.7
- value
- 0.0188
- group Id
- OG004
- spread
- 52.3
- value
- 0.0309
- group Id
- OG005
- spread
- 46.5
- value
- 0.0568
- group Id
- OG006
- spread
- 68.8
- value
- 0.137
- group Id
- OG007
- spread
- 75.7
- value
- 0.0930
- group Id
- OG008
- spread
- 37.2
- value
- 0.0296
- group Id
- OG009
- spread
- 79.4
- value
- 0.0536
- group Id
- OG010
- spread
- 19.7
- value
- 0.0957
- group Id
- OG011
- spread
- 43.6
- value
- 0.0816
- 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
- 3
- units
- Participants
- title
- Clast: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 59.7
- value
- 0.0151
- group Id
- OG001
- spread
- 102
- value
- 0.00902
- group Id
- OG002
- spread
- 77.2
- value
- 0.0199
- group Id
- OG003
- spread
- 81.4
- value
- 0.0230
- group Id
- OG004
- spread
- 48.7
- value
- 0.0548
- group Id
- OG005
- spread
- 20.1
- value
- 0.0876
- group Id
- OG006
- spread
- 86.9
- value
- 0.0831
- group Id
- OG007
- spread
- 80.9
- value
- 0.215
- 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
- Clast: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 39.5
- value
- 0.141
- group Id
- OG009
- spread
- 53.1
- value
- 0.293
- group Id
- OG010
- spread
- 53.3
- value
- 0.322
- group Id
- OG011
- spread
- 20.3
- value
- 0.116
- 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
- 3
- units
- Participants
- title
- Clast: Day 28
- categories
- measurements
- group Id
- OG000
- spread
- 19.9
- value
- 0.00385
- group Id
- OG001
- spread
- 32.9
- value
- 0.0102
- group Id
- OG002
- spread
- 22.9
- value
- 0.0168
- group Id
- OG003
- spread
- 34.1
- value
- 0.0230
- group Id
- OG004
- spread
- 65.9
- value
- 0.0591
- group Id
- OG005
- spread
- 54.1
- value
- 0.0931
- group Id
- OG006
- spread
- 61.2
- value
- 0.0905
- group Id
- OG007
- spread
- 78.6
- value
- 0.143
- group Id
- OG008
- spread
- 61.5
- value
- 0.0455
- group Id
- OG009
- spread
- 27.9
- value
- 0.0554
- group Id
- OG010
- spread
- 61.1
- value
- 0.0883
- group Id
- OG011
- spread
- 46.4
- value
- 0.0172
- 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
- 3
- units
- Participants
- title
- Cavg: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 41.3
- value
- 0.0423
- group Id
- OG001
- spread
- 56.3
- value
- 0.0392
- group Id
- OG002
- spread
- 30.2
- value
- 0.0740
- group Id
- OG003
- spread
- 32.0
- value
- 0.0890
- group Id
- OG004
- spread
- 37.3
- value
- 0.200
- group Id
- OG005
- spread
- 27.1
- value
- 0.421
- group Id
- OG006
- spread
- 50.4
- value
- 0.349
- group Id
- OG007
- spread
- 54.6
- value
- 0.351
- 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
- 9
- 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
- Cavg: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 36.1
- value
- 0.183
- group Id
- OG009
- spread
- 48.2
- value
- 0.277
- group Id
- OG010
- spread
- 56.2
- value
- 0.378
- group Id
- OG011
- spread
- 69.8
- value
- 0.118
- 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
- 3
- units
- Participants
- title
- Cavg: 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 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 120 mg 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 270 mg 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 Parameters: Maximum Plasma Concentration (Cmax), Last Measurable Concentration (Clast), and Average Concentration (Cavg) of NMS-03592088
- type
- SECONDARY
- unit Of Measure
- μM
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Preserved source evidence · Not medical advice
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