TriangleNCT01546038 · OUTCOME
Percentage of Participants With Complete Response (CR) at Phase 2 Fit
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 AML participants:CR were those with repeat bone marrow showing \<5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils\>=1000/mcL and platelets\>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing \<=5% myeloblasts, peripheral blood showing neutrophils\>=1000/mcL, platelets\>=100,000/mcL, 0% blast and hemoglobin (Hgb)\>= 11 g/dL, normal maturation of all cell lines.
Analysis population: Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
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.
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 69 |
Reported measurements
Total participants
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 69 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 42.0 | Not reported | 34.4 | 49.6 | Not reported |
Participants >= 55 years old
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 60 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 36.7 | Not reported | 28.7 | 44.6 | Not reported |
Participants < 55 years old
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 77.8 | Not reported | 60.0 | 95.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.4
- upper Limit
- 49.6
- value
- 42.0
- denoms
- counts
- group Id
- OG000
- value
- 69
- units
- Participants
- title
- Total participants
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.7
- upper Limit
- 44.6
- value
- 36.7
- denoms
- counts
- group Id
- OG000
- value
- 60
- units
- Participants
- title
- Participants >= 55 years old
- categories
- measurements
- group Id
- OG000
- lower Limit
- 60.0
- upper Limit
- 95.5
- value
- 77.8
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- title
- Participants < 55 years old
- denoms
- counts
- group Id
- OG000
- value
- 69
- units
- Participants
- description
- For AML participants:CR were those with repeat bone marrow showing \<5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils\>=1000/mcL and platelets\>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing \<=5% myeloblasts, peripheral blood showing neutrophils\>=1000/mcL, platelets\>=100,000/mcL, 0% blast and hemoglobin (Hgb)\>= 11 g/dL, normal maturation of all cell lines.
- 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
- param Type
- NUMBER
- population Description
- Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
- reporting Status
- POSTED
- time Frame
- 4 years
- title
- Percentage of Participants With Complete Response (CR) at Phase 2 Fit
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice