TriangleNCT01546038 · OUTCOME
Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria 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
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 1 year
What was measured
Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with QTcF meeting the following criteria is presented:QTcF interval:\<450 msec; QTcF interval: 450 to \<480 msec; QTcF interval: 480 to \<500 msec; QTcF interval \>=500 msec; QTcF interval increase from baseline: \<30 msec; QTcF interval increase from baseline: 30 to \<60 msec; QTcF interval increase from baseline \>=60 msec. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.
Analysis population: QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.
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 | 68 |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 83 |
| Phase 2 Unfit: LDAC Alone | 17 |
Reported measurements
QTcF interval increase < 30 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 41 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 60 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: LDAC Alone | 12 | Not reported | Not reported | Not reported | Not reported |
QTcF interval increase: 30 to < 60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 21 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 19 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: LDAC Alone | 4 | Not reported | Not reported | Not reported | Not reported |
QTcF interval increase >= 60 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: LDAC Alone | 1 | Not reported | Not reported | Not reported | Not reported |
Maximum QTcF interval < 450 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 46 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 46 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: LDAC Alone | 8 | Not reported | Not reported | Not reported | Not reported |
Maximum QTcF interval: 450 to < 480 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 18 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 29 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: LDAC Alone | 4 | Not reported | Not reported | Not reported | Not reported |
Maximum QTcF interval: 480 to < 500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: LDAC Alone | 3 | Not reported | Not reported | Not reported | Not reported |
Maximum QTcF interval >= 500 msec
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Unfit: LDAC Alone | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 12
- title
- QTcF interval increase < 30 msec
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 4
- title
- QTcF interval increase: 30 to < 60 msec
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- title
- QTcF interval increase >= 60 msec
- categories
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 46
- group Id
- OG002
- value
- 8
- title
- Maximum QTcF interval < 450 msec
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 4
- title
- Maximum QTcF interval: 450 to < 480 msec
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- title
- Maximum QTcF interval: 480 to < 500 msec
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- title
- Maximum QTcF interval >= 500 msec
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 17
- units
- Participants
- description
- Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with QTcF meeting the following criteria is presented:QTcF interval:\<450 msec; QTcF interval: 450 to \<480 msec; QTcF interval: 480 to \<500 msec; QTcF interval \>=500 msec; QTcF interval increase from baseline: \<30 msec; QTcF interval increase from baseline: 30 to \<60 msec; QTcF interval increase from baseline \>=60 msec. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.
- 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
- QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.
- reporting Status
- POSTED
- time Frame
- 1 year
- title
- Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria at Phase 2 Fit and Unfit
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice