TriangleNCT01546038 · OUTCOME
Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- pg/mL
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1/Day 10, Pre-dose
What was measured
Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant differences compared with baseline are reported here. ITAC (Interferon-inducible T-cell α chemoattractant) level in LDAC alone arm at Cycle 1/Day 10 exhibited non-significant change from baseline but similar trends as in Glasdegib 100 mg+LDAC arm.
Analysis population: PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample 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.
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 Unfit: Glasdegib 100 mg + LDAC | 66 |
| Phase 2 Unfit: LDAC Alone | 24 |
Reported measurements
BDNF
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 500 | Not reported | 0 | 7200 | Not reported |
| Phase 2 Unfit: LDAC Alone | 200 | Not reported | 0 | 5100 | Not reported |
ITAC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 7.5 | Not reported | 0.00 | 226.00 | Not reported |
| Phase 2 Unfit: LDAC Alone | 0.00 | Not reported | 0.00 | 71.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 7200
- value
- 500
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 5100
- value
- 200
- title
- BDNF
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 226.00
- value
- 7.5
- group Id
- OG001
- lower Limit
- 0.00
- upper Limit
- 71.00
- value
- 0.00
- title
- ITAC
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant differences compared with baseline are reported here. ITAC (Interferon-inducible T-cell α chemoattractant) level in LDAC alone arm at Cycle 1/Day 10 exhibited non-significant change from baseline but similar trends as in Glasdegib 100 mg+LDAC arm.
- 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
- description
- Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
- id
- OG001
- title
- Phase 2 Unfit: LDAC Alone
- param Type
- MEDIAN
- population Description
- PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.
- reporting Status
- POSTED
- time Frame
- Cycle 1/Day 10, Pre-dose
- title
- Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 10
- type
- SECONDARY
- unit Of Measure
- pg/mL
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Preserved source evidence · Not medical advice