TriangleNCT01546038 · OUTCOME
Ratios of mRNA Levels to Baseline at Phase 2 Fit - End of Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ratio
- Interval / dispersion
- Full Range
- Time frame
- Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)
What was measured
Whole blood mRNA analyses were performed on 21 mRNA candidates. Selected values showing statistically significant differences compared with baseline are reported here. CCND2:G1/S-Specific Cyclin D2; MSI2: Musashi RNA Binding Protein 2; PTCH2: Patched 2.
Analysis population: PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.
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 | 62 |
Reported measurements
CCND2
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 42 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.80 | Not reported | 0.23 | 3.23 | Not reported |
MSI2
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 42 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.80 | Not reported | 0.31 | 4.58 | Not reported |
PTCH2
| Group | Source count |
|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin | 0.70 | Not reported | 0.29 | 1.90 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.23
- upper Limit
- 3.23
- value
- 0.80
- denoms
- counts
- group Id
- OG000
- value
- 42
- units
- Participants
- title
- CCND2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.31
- upper Limit
- 4.58
- value
- 0.80
- denoms
- counts
- group Id
- OG000
- value
- 42
- units
- Participants
- title
- MSI2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.29
- upper Limit
- 1.90
- value
- 0.70
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- title
- PTCH2
- denoms
- counts
- group Id
- OG000
- value
- 62
- units
- Participants
- description
- Whole blood mRNA analyses were performed on 21 mRNA candidates. Selected values showing statistically significant differences compared with baseline are reported here. CCND2:G1/S-Specific Cyclin D2; MSI2: Musashi RNA Binding Protein 2; PTCH2: Patched 2.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.
- reporting Status
- POSTED
- time Frame
- Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)
- title
- Ratios of mRNA Levels to Baseline at Phase 2 Fit - End of Treatment
- type
- SECONDARY
- unit Of Measure
- ratio
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Preserved source evidence · Not medical advice