TriangleNCT01546038 · OUTCOME
Percentage of Participants With Disease-specific Efficacy for Acute Myeloid Leukemia (AML) at Phase 2 Fit and Unfit
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- 4 years
What was measured
AML participants,disease specific efficacy measures included:CRi;Morphologic Leukemia Free State(MLFS)(bone marrow\<5%myeloblasts with spicules and no blasts with auer rods,neutrophils\<1000/mcL and platelets\<100,000/mcL);partial remission(PR)(bone marrow myeloblasts decrease to 5-25\&\>=50%decrease from start, neutrophils\>=1000/mcL, platelets\>=100,000/mcL);PR with incomplete blood count recovery(PRi)(bone marrow myeloblasts decrease to 5-25\&\>=50%decrease from start,neutrophils\<1000/mcL or platelets\<100,000/mcL);minor response(MR)(bone marrow myeloblasts decrease to\>=25% from start);stable disease(SD)(bone marrow myeloblasts stable+/-25% from screening value);cytogenetic complete response(CRc)(bone marrow\<5%myeloblasts, neutrophils\>1000/mcL, platelets\>100,000/mcL and normal cytogenetics),molecular complete response(CRm)(bone marrow\<5%myeloblasts, neutrophils\>1000/mcL, platelets\>100,000/mcL and molecular-negative).
Analysis population: AML participants in the Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication, and all randomized participants of Phase 2 Unfit arm.
Groups in this outcome
Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
Phase 2 Unfit: Glasdegib 100 mg + LDAC
Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
Phase 2 Unfit: LDAC Alone
Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 64 |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 78 |
| Phase 2 Unfit: LDAC Alone | 38 |
Reported measurements
CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 10.9 | Not reported | 6.2 | 17.7 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 5.1 | Not reported | 2.3 | 10.0 | Not reported |
| Phase 2 Unfit: LDAC Alone | 2.6 | Not reported | 0.3 | 9.9 | Not reported |
MLFS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 7.8 | Not reported | 3.8 | 14.0 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 2.6 | Not reported | 0.7 | 6.7 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 5.9 | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 1.6 | Not reported | 0.2 | 5.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 6.4 | Not reported | 3.2 | 11.6 | Not reported |
| Phase 2 Unfit: LDAC Alone | 2.6 | Not reported | 0.3 | 9.9 | Not reported |
PRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 1.6 | Not reported | 0.2 | 5.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 1.3 | Not reported | 0.1 | 4.9 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 5.9 | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 10.9 | Not reported | 6.2 | 17.7 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 6.4 | Not reported | 3.2 | 11.6 | Not reported |
| Phase 2 Unfit: LDAC Alone | 10.5 | Not reported | 4.7 | 19.9 | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 6.3 | Not reported | 2.8 | 12.1 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 16.7 | Not reported | 11.3 | 23.4 | Not reported |
| Phase 2 Unfit: LDAC Alone | 21.1 | Not reported | 12.7 | 31.9 | Not reported |
CRc
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 35.9 | Not reported | 27.9 | 44.7 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 11.5 | Not reported | 7.1 | 17.6 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 5.9 | Not reported |
CRm
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 37.5 | Not reported | 29.4 | 46.2 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 16.7 | Not reported | 11.3 | 23.4 | Not reported |
| Phase 2 Unfit: LDAC Alone | 2.6 | Not reported | 0.3 | 9.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.2
- upper Limit
- 17.7
- value
- 10.9
- group Id
- OG001
- lower Limit
- 2.3
- upper Limit
- 10.0
- value
- 5.1
- group Id
- OG002
- lower Limit
- 0.3
- upper Limit
- 9.9
- value
- 2.6
- title
- CRi
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.8
- upper Limit
- 14.0
- value
- 7.8
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 6.7
- value
- 2.6
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 5.9
- value
- 0.0
- title
- MLFS
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 5.9
- value
- 1.6
- group Id
- OG001
- lower Limit
- 3.2
- upper Limit
- 11.6
- value
- 6.4
- group Id
- OG002
- lower Limit
- 0.3
- upper Limit
- 9.9
- value
- 2.6
- title
- PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 5.9
- value
- 1.6
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 4.9
- value
- 1.3
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 5.9
- value
- 0.0
- title
- PRi
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.2
- upper Limit
- 17.7
- value
- 10.9
- group Id
- OG001
- lower Limit
- 3.2
- upper Limit
- 11.6
- value
- 6.4
- group Id
- OG002
- lower Limit
- 4.7
- upper Limit
- 19.9
- value
- 10.5
- title
- MR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 12.1
- value
- 6.3
- group Id
- OG001
- lower Limit
- 11.3
- upper Limit
- 23.4
- value
- 16.7
- group Id
- OG002
- lower Limit
- 12.7
- upper Limit
- 31.9
- value
- 21.1
- title
- SD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.9
- upper Limit
- 44.7
- value
- 35.9
- group Id
- OG001
- lower Limit
- 7.1
- upper Limit
- 17.6
- value
- 11.5
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 5.9
- value
- 0.0
- title
- CRc
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.4
- upper Limit
- 46.2
- value
- 37.5
- group Id
- OG001
- lower Limit
- 11.3
- upper Limit
- 23.4
- value
- 16.7
- group Id
- OG002
- lower Limit
- 0.3
- upper Limit
- 9.9
- value
- 2.6
- title
- CRm
- denoms
- counts
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 38
- units
- Participants
- description
- AML participants,disease specific efficacy measures included:CRi;Morphologic Leukemia Free State(MLFS)(bone marrow\<5%myeloblasts with spicules and no blasts with auer rods,neutrophils\<1000/mcL and platelets\<100,000/mcL);partial remission(PR)(bone marrow myeloblasts decrease to 5-25\&\>=50%decrease from start, neutrophils\>=1000/mcL, platelets\>=100,000/mcL);PR with incomplete blood count recovery(PRi)(bone marrow myeloblasts decrease to 5-25\&\>=50%decrease from start,neutrophils\<1000/mcL or platelets\<100,000/mcL);minor response(MR)(bone marrow myeloblasts decrease to\>=25% from start);stable disease(SD)(bone marrow myeloblasts stable+/-25% from screening value);cytogenetic complete response(CRc)(bone marrow\<5%myeloblasts, neutrophils\>1000/mcL, platelets\>100,000/mcL and normal cytogenetics),molecular complete response(CRm)(bone marrow\<5%myeloblasts, neutrophils\>1000/mcL, platelets\>100,000/mcL and molecular-negative).
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.
- id
- OG000
- title
- Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin
- description
- Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
- id
- OG001
- title
- Phase 2 Unfit: Glasdegib 100 mg + LDAC
- description
- Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
- id
- OG002
- title
- Phase 2 Unfit: LDAC Alone
- param Type
- NUMBER
- population Description
- AML participants in the Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication, and all randomized participants of Phase 2 Unfit arm.
- reporting Status
- POSTED
- time Frame
- 4 years
- title
- Percentage of Participants With Disease-specific Efficacy for Acute Myeloid Leukemia (AML) at Phase 2 Fit and Unfit
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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