TriangleNCT03922100 · OUTCOME
Best Response Rate for Participants With Acute Myeloblastic Leukemia (AML).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of treatment initiation up to end of study (approximately 1.5 years)
What was measured
For participants with AML diagnosis the number and percentage of participants with best response achieved on treatment in the following categories: CR, CRi, CRh, PR, MLFS, SD, No Response and Progressive Disease (PD). CR= complete response; CRh= Complete Remission with Partial Hematologic Recovery, CRi= Complete Remission with Incomplete Hematologic Recovery; CRc= Complete Remission Rate; MLFS= Morphologic leukemia free state; ORR= Overall Response Rate; PR= Partial Remission; SD= Stable Disease
Analysis population: Participants with AML FLT3 mutation based on local assessment based on efficacy dataset (Participants evaluable for efficacy analysis): This population consisted of all enrolled Participants in the Phase II who were treated at the recommended Phase II dose (RP2D) and had ≥1 on-treatment hematologic assessment(s) (ie, they must have had adequate BM response evaluation).
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, Cohort 1:360+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
Phase 2, Schedule B, Cohort 2: 360+150 mg
Participants who had failed standard of care. 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, Cohort 1:360+150 mg | 5 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 10 |
Reported measurements
No Response/SD
| 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, Cohort 1:360+150 mg | 3 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 1:360+150 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 6 | Not reported | Not reported | Not reported | Not reported |
CRc: CR + CRi
| 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, Cohort 1:360+150 mg | 3 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 1:360+150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 1 | Not reported | Not reported | Not reported | Not reported |
CR+CRh+CRi
| 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, Cohort 1:360+150 mg | 3 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 1:360+150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 1 | Not reported | Not reported | Not reported | Not reported |
ORR:CR+CRh+CRi+MLFS+PR
| 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, Cohort 1:360+150 mg | 3 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 1:360+150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 3 | Not reported | Not reported | Not reported | Not reported |
CRi
| 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, Cohort 1:360+150 mg | 3 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 1:360+150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 1 | Not reported | Not reported | Not reported | Not reported |
MLFS
| 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, Cohort 1:360+150 mg | 3 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Schedule A: 20 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 40 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 80 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 270 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 300 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule A: 360 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 120 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 180 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Schedule B: 250 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 1:360+150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- 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
- 3
- units
- Participants
- title
- No Response/SD
- categories
- measurements
- 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
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- 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
- 3
- units
- Participants
- title
- CRc: CR + CRi
- categories
- measurements
- 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
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- 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
- 3
- units
- Participants
- title
- CR+CRh+CRi
- categories
- measurements
- 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
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- 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
- 3
- units
- Participants
- title
- ORR:CR+CRh+CRi+MLFS+PR
- categories
- measurements
- 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
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- 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
- 3
- units
- Participants
- title
- CRi
- categories
- measurements
- 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
- 2
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- 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
- 3
- units
- Participants
- title
- MLFS
- 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
- 5
- units
- Participants
- description
- For participants with AML diagnosis the number and percentage of participants with best response achieved on treatment in the following categories: CR, CRi, CRh, PR, MLFS, SD, No Response and Progressive Disease (PD). CR= complete response; CRh= Complete Remission with Partial Hematologic Recovery, CRi= Complete Remission with Incomplete Hematologic Recovery; CRc= Complete Remission Rate; MLFS= Morphologic leukemia free state; ORR= Overall Response Rate; PR= Partial Remission; SD= Stable Disease
- 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, Cohort 1:360+150 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants with AML FLT3 mutation based on local assessment based on efficacy dataset (Participants evaluable for efficacy analysis): This population consisted of all enrolled Participants in the Phase II who were treated at the recommended Phase II dose (RP2D) and had ≥1 on-treatment hematologic assessment(s) (ie, they must have had adequate BM response evaluation).
- reporting Status
- POSTED
- time Frame
- From the date of treatment initiation up to end of study (approximately 1.5 years)
- title
- Best Response Rate for Participants With Acute Myeloblastic Leukemia (AML).
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice