TriangleNCT01546038 · OUTCOME
Percentage of Participants With Disease-specific Efficacy for Myelodysplastic Syndrome (MDS) 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
For all MDS participants, disease specific efficacy measures included: CRi (bone marrow showing \<5% myeloblasts with platelets \<100,000/mcL or neutrophils \<1000/mcL, including confirmed and unconfirmed responses); PR (repeat bone marrow myeloblasts showing decreased by \>= 50% decrease but still \>5%, peripheral blood showing neutrophils \>= 1,000/mcL, platelets \>= 100,000/mcL and Hgb\>=11g/dL; including confirmed and unconfirmed responses); SD (including confirmed and unconfirmed responses, failure to achieve PR and no evidence of progression for \>8 weeks); marrow complete response (mCR) (bone marrow showing \<=5% myeloblasts and decreased by \>= 50%), partial cytogenetic response (\>=50% reduction of chromosomal abnormality) and complete cytogenetic response (CRc) (disappearance of chromosomal abnormality with no appearance of now ones).
Analysis population: MDS 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 | 5 |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 10 |
| Phase 2 Unfit: LDAC Alone | 6 |
Reported measurements
mCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.0 | Not reported | 0.0 | 36.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 10.0 | Not reported | 1.0 | 33.7 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 31.9 | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.0 | Not reported | 0.0 | 36.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 0.0 | Not reported | 0.0 | 20.6 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 31.9 | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.0 | Not reported | 0.0 | 36.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 0.0 | Not reported | 0.0 | 20.6 | Not reported |
| Phase 2 Unfit: LDAC Alone | 33.3 | Not reported | 9.3 | 66.7 | Not reported |
CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 20.0 | Not reported | 2.1 | 58.4 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 10.0 | Not reported | 1.0 | 33.7 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 31.9 | Not reported |
Unconfirmed SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.0 | Not reported | 0.0 | 36.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 10.0 | Not reported | 1.0 | 33.7 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 31.9 | Not reported |
Unconfirmed CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.0 | Not reported | 0.0 | 36.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 10.0 | Not reported | 1.0 | 33.7 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 31.9 | Not reported |
mCR (CRi not included)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.0 | Not reported | 0.0 | 36.9 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 10.0 | Not reported | 1.0 | 33.7 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 31.9 | Not reported |
CRc
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 60.0 | Not reported | 24.7 | 88.8 | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 10.0 | Not reported | 1.0 | 33.7 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.0 | Not reported | 0.0 | 31.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 33.7
- value
- 10.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 31.9
- value
- 0.0
- title
- mCR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 20.6
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 31.9
- value
- 0.0
- title
- PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 20.6
- value
- 0.0
- group Id
- OG002
- lower Limit
- 9.3
- upper Limit
- 66.7
- value
- 33.3
- title
- SD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 58.4
- value
- 20.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 33.7
- value
- 10.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 31.9
- value
- 0.0
- title
- CRi
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 33.7
- value
- 10.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 31.9
- value
- 0.0
- title
- Unconfirmed SD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 33.7
- value
- 10.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 31.9
- value
- 0.0
- title
- Unconfirmed CRi
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 36.9
- value
- 0.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 33.7
- value
- 10.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 31.9
- value
- 0.0
- title
- mCR (CRi not included)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.7
- upper Limit
- 88.8
- value
- 60.0
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 33.7
- value
- 10.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 31.9
- value
- 0.0
- title
- CRc
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- For all MDS participants, disease specific efficacy measures included: CRi (bone marrow showing \<5% myeloblasts with platelets \<100,000/mcL or neutrophils \<1000/mcL, including confirmed and unconfirmed responses); PR (repeat bone marrow myeloblasts showing decreased by \>= 50% decrease but still \>5%, peripheral blood showing neutrophils \>= 1,000/mcL, platelets \>= 100,000/mcL and Hgb\>=11g/dL; including confirmed and unconfirmed responses); SD (including confirmed and unconfirmed responses, failure to achieve PR and no evidence of progression for \>8 weeks); marrow complete response (mCR) (bone marrow showing \<=5% myeloblasts and decreased by \>= 50%), partial cytogenetic response (\>=50% reduction of chromosomal abnormality) and complete cytogenetic response (CRc) (disappearance of chromosomal abnormality with no appearance of now ones).
- 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
- MDS 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 Myelodysplastic Syndrome (MDS) at Phase 2 Fit and Unfit
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice