NCT03922100 · OUTCOME
Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax), Time to Last Measurable Concentration (Tlast), and Terminal Elimination Half-life (t½,z) 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
- hour
- Interval / dispersion
- Standard Deviation
- Time frame
- Schedule A: Day 1 and 21 Schedule B: Day 1 and 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 (participants with sufficient samples to provide interpretable results). The plasma PK of NMS-03592088 and NMS-03593860 and NMS-03603422 were collected for PK profile.
Schedule B involved 28 days continuous treatment. Last sampling time was 24 hrs after dosing on day 1 \& 28.
This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
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
Tmax: 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 hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 6.00 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 3.33 | 69.3 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 10.4 | 90.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 3.01 | 87.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 1.67 | 35.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 3.02 | 65.8 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 3.78 | 41.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 4.66 | 24.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 120 mg | 4.00 | 57.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 3.65 | 41.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 3.25 | 83.9 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 2.73 | 46.5 | Not reported | Not reported | Not reported |
|---|
Tmax: 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 hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 1.67 | 125 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 3.00 | 88.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 4.00 | 50.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 3.33 | 69.3 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 9.31 | 136 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 4.00 | 44.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 5.41 | 108 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 4.41 | 37.7 | Not reported | Not reported | Not reported |
|---|
Tmax: 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 hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule B: 120 mg | 2.33 | 58.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 6.00 | 49.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 2.80 | 63.9 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 4.33 | 34.7 | Not reported | Not reported | Not reported |
|---|
Tlast: 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 | 15 |
|---|
Values in hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 23.5 | 1.05 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 22.5 | 3.23 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 21.1 | 11.9 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 22.7 | 7.15 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 22.6 | 13.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 23.4 | 2.14 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 16.4 | 50.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 22.4 | 6.78 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 120 mg | 23.2 | 2.79 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 20.0 | 34.8 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 18.5 | 45.6 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 5.96 | 1.29 | Not reported | Not reported | Not reported |
|---|
Tlast: 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 hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 160 | 35.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 194 | 0.998 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 170 | 25.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 170 | 43.8 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 120 | 39.7 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 160 | 31.1 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 183 | 26.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 120 | 60.2 | Not reported | Not reported | Not reported |
|---|
Tlast: 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 hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule B: 120 mg | 24.0 | 0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 180 mg | 22.0 | 22.8 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule B: 250 mg | 24.0 | 0.309 | Not reported | Not reported | Not reported |
|---|
| Phase 2, Schedule B: 360+150 mg | 17.9 | 57.5 | Not reported | Not reported | Not reported |
|---|
t½,z: Day 1
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 |
|---|
Values in hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule A: 40 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule A: 80 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule A: 120 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule A: 180 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule A: 270 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule A: 300 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule A: 360 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule B: 120 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule B: 180 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule B: 250 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 2, Schedule B: 360+150 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
t½,z: 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 hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule A: 20 mg | 89.5 | 19.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 40 mg | 79.5 | 35.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 80 mg | 71.7 | 4.35 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 120 mg | 68.4 | 18.2 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 180 mg | 57.3 | 32.3 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 270 mg | 63.7 | 24.0 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 300 mg | 77.3 | 16.4 | Not reported | Not reported | Not reported |
|---|
| Phase 1, Schedule A: 360 mg | 150 | 0 | Not reported | Not reported | Not reported |
|---|
t½,z: 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 | 15 |
|---|
Values in hour · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1, Schedule B: 120 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule B: 180 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 1, Schedule B: 250 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
| Phase 2, Schedule B: 360+150 mg | NA | NA | Not reported | Not reported | Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 6.00
- group Id
- OG001
- spread
- 69.3
- value
- 3.33
- group Id
- OG002
- spread
- 90.4
- value
- 10.4
- group Id
- OG003
- spread
- 87.7
- value
- 3.01
- group Id
- OG004
- spread
- 35.0
- value
- 1.67
- group Id
- OG005
- spread
- 65.8
- value
- 3.02
- group Id
- OG006
- spread
- 41.7
- value
- 3.78
- group Id
- OG007
- spread
- 24.4
- value
- 4.66
- group Id
- OG008
- spread
- 57.7
- value
- 4.00
- group Id
- OG009
- spread
- 41.7
- value
- 3.65
- group Id
- OG010
- spread
- 83.9
- value
- 3.25
- group Id
- OG011
- spread
- 46.5
- value
- 2.73
- 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
- Tmax: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 125
- value
- 1.67
- group Id
- OG001
- spread
- 88.2
- value
- 3.00
- group Id
- OG002
- spread
- 50.0
- value
- 4.00
- group Id
- OG003
- spread
- 69.3
- value
- 3.33
- group Id
- OG004
- spread
- 136
- value
- 9.31
- group Id
- OG005
- spread
- 44.7
- value
- 4.00
- group Id
- OG006
- spread
- 108
- value
- 5.41
- group Id
- OG007
- spread
- 37.7
- value
- 4.41
- 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
- Tmax: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 58.6
- value
- 2.33
- group Id
- OG009
- spread
- 49.5
- value
- 6.00
- group Id
- OG010
- spread
- 63.9
- value
- 2.80
- group Id
- OG011
- spread
- 34.7
- value
- 4.33
- 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
- Tmax: Day 28
- categories
- measurements
- group Id
- OG000
- spread
- 1.05
- value
- 23.5
- group Id
- OG001
- spread
- 3.23
- value
- 22.5
- group Id
- OG002
- spread
- 11.9
- value
- 21.1
- group Id
- OG003
- spread
- 7.15
- value
- 22.7
- group Id
- OG004
- spread
- 13.0
- value
- 22.6
- group Id
- OG005
- spread
- 2.14
- value
- 23.4
- group Id
- OG006
- spread
- 50.6
- value
- 16.4
- group Id
- OG007
- spread
- 6.78
- value
- 22.4
- group Id
- OG008
- spread
- 2.79
- value
- 23.2
- group Id
- OG009
- spread
- 34.8
- value
- 20.0
- group Id
- OG010
- spread
- 45.6
- value
- 18.5
- group Id
- OG011
- spread
- 1.29
- value
- 5.96
- 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
- Tlast: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 35.2
- value
- 160
- group Id
- OG001
- spread
- 0.998
- value
- 194
- group Id
- OG002
- spread
- 25.4
- value
- 170
- group Id
- OG003
- spread
- 43.8
- value
- 170
- group Id
- OG004
- spread
- 39.7
- value
- 120
- group Id
- OG005
- spread
- 31.1
- value
- 160
- group Id
- OG006
- spread
- 26.6
- value
- 183
- group Id
- OG007
- spread
- 60.2
- value
- 120
- 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
- Tlast: Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 0
- value
- 24.0
- group Id
- OG009
- spread
- 22.8
- value
- 22.0
- group Id
- OG010
- spread
- 0.309
- value
- 24.0
- group Id
- OG011
- spread
- 57.5
- value
- 17.9
- 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
- Tlast: Day 28
- categories
- measurements
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG002
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG004
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG005
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG007
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG008
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG009
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG010
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG011
- spread
- NA
- value
- NA
- 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
- title
- t½,z: Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 19.5
- value
- 89.5
- group Id
- OG001
- spread
- 35.2
- value
- 79.5
- group Id
- OG002
- spread
- 4.35
- value
- 71.7
- group Id
- OG003
- spread
- 18.2
- value
- 68.4
- group Id
- OG004
- spread
- 32.3
- value
- 57.3
- group Id
- OG005
- spread
- 24.0
- value
- 63.7
- group Id
- OG006
- spread
- 16.4
- value
- 77.3
- group Id
- OG007
- spread
- 0
- value
- 150
- 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
- t½,z: Day 21
- categories
- measurements
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG008
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG009
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG010
- spread
- NA
- value
- NA
- comment
- Last sampling time was 24 hrs after dosing on day 1 \& 28. This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- group Id
- OG011
- spread
- NA
- value
- NA
- 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
- t½,z: 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 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 (participants with sufficient samples to provide interpretable results). The plasma PK of NMS-03592088 and NMS-03593860 and NMS-03603422 were collected for PK profile.
Schedule B involved 28 days continuous treatment. Last sampling time was 24 hrs after dosing on day 1 \& 28.
This limited sampling times didn't allow calculation of t½, of the terminal phase, characterised by long half-lives, shown by data from schedule A. Hence evaluation was not performed.
- reporting Status
- POSTED
- time Frame
- Schedule A: Day 1 and 21 Schedule B: Day 1 and 28
- title
- Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax), Time to Last Measurable Concentration (Tlast), and Terminal Elimination Half-life (t½,z) of NMS-03592088
- type
- SECONDARY
- unit Of Measure
- hour
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