TriangleNCT01546038 · OUTCOME
Ratios of mRNA Levels to Baseline at Phase 2 Unfit - 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 (Cycle 1/Day 1 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. Only the analytes showing statistically significant change from baseline are reported here.
Analysis population: PD analysis set:all enrolled participants in Phase 2 Unfit 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 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.
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 47 |
Reported measurements
CCND2
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 30 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 0.70 | Not reported | 0.06 | 2.35 | Not reported |
SMO
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 20 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 0.40 | Not reported | 0.09 | 8.09 | Not reported |
CCND1
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 17 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 0.40 | Not reported | 0.10 | 13.33 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.06
- upper Limit
- 2.35
- value
- 0.70
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- title
- CCND2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.09
- upper Limit
- 8.09
- value
- 0.40
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- title
- SMO
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.10
- upper Limit
- 13.33
- value
- 0.40
- denoms
- counts
- group Id
- OG000
- value
- 17
- units
- Participants
- title
- CCND1
- denoms
- counts
- group Id
- OG000
- value
- 47
- units
- Participants
- description
- Whole blood mRNA analyses were performed on 21 mRNA candidates. Only the analytes showing statistically significant change from baseline are reported here.
- dispersion Type
- Full Range
- groups
- 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
- OG000
- title
- Phase 2 Unfit: Glasdegib 100 mg + LDAC
- param Type
- MEDIAN
- population Description
- PD analysis set:all enrolled participants in Phase 2 Unfit 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 (Cycle 1/Day 1 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 Unfit - End of Treatment
- type
- SECONDARY
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice