TriangleNCT03922100 · OUTCOME
Pharmacokinetic Parameters: Fraction Excreted Unchanged (FE) of NMS-03592088
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage
- Interval / dispersion
- Standard Deviation
- Time frame
- Schedule A: Day 21 Schedule B: Day 28 Evaluation of Fraction excreted unchanged (FE) for Arms 20, 40, 80, 120 and 180 mg of Schedule A and Arm 360+150 mg of Schedule B has not been performed.
What was measured
Urine samples were collected and used for pharmacokinetics (PK) assessments. Only cohorts with available data are presented. The assessment was performed only during the Phase I of the study. 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 PK of NMS-03592088, NMS-03593860 \& NMS-03603422 were collected. Urine was collected in all participants enrolled starting from the dose level 6 (Schedule A) or the first dose level (Schedule B). Per protocol this assessment was performed only during the Phase I of the study hence data not available for Phase 2 and for first 5 dose levels of Schedule A (20-180 mg).
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 | 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 | 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 | 0 |
Reported measurements
Day 21
| 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 | 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: 270 mg | 0.0321 | 76.4 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 0.0396 | 137 | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 0.0812 | 49.4 | Not reported | Not reported | Not reported |
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 | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule B: 120 mg | 0.0301 | 42.2 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 0.0577 | 67.4 | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 0.0299 | 44.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG005
- spread
- 76.4
- value
- 0.0321
- group Id
- OG006
- spread
- 137
- value
- 0.0396
- group Id
- OG007
- spread
- 49.4
- value
- 0.0812
- 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
- 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
- Day 21
- categories
- measurements
- group Id
- OG008
- spread
- 42.2
- value
- 0.0301
- group Id
- OG009
- spread
- 67.4
- value
- 0.0577
- group Id
- OG010
- spread
- 44.9
- value
- 0.0299
- 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
- 0
- units
- Participants
- title
- Day 28
- 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
- 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
- 0
- units
- Participants
- description
- Urine samples were collected and used for pharmacokinetics (PK) assessments. Only cohorts with available data are presented. The assessment was performed only during the Phase I of the study. 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 PK of NMS-03592088, NMS-03593860 \& NMS-03603422 were collected. Urine was collected in all participants enrolled starting from the dose level 6 (Schedule A) or the first dose level (Schedule B). Per protocol this assessment was performed only during the Phase I of the study hence data not available for Phase 2 and for first 5 dose levels of Schedule A (20-180 mg).
- reporting Status
- POSTED
- time Frame
- Schedule A: Day 21 Schedule B: Day 28 Evaluation of Fraction excreted unchanged (FE) for Arms 20, 40, 80, 120 and 180 mg of Schedule A and Arm 360+150 mg of Schedule B has not been performed.
- title
- Pharmacokinetic Parameters: Fraction Excreted Unchanged (FE) of NMS-03592088
- type
- SECONDARY
- unit Of Measure
- percentage
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Preserved source evidence · Not medical advice