TriangleNCT02367456 · OUTCOME
Maximum Plasma Concentration (Cmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) in the Lead-in Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose and 0.25, 1, 4, 6, 24 hours post-dose on Cycle 1 Day 7 and Cycle 1 Day 15
What was measured
Maximum plasma concentration of glasdegib dosed in combination with azacitidine (C1D7) and when dosed alone (C1D15) in the Lead-in Cohort was estimated using non-compartmental analysis.
Analysis population: The PK concentration analysis set included all participants who received treatment and had at least 1 value of analyte concentration of glasdegib or azacitidine available. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = number of participants with evaluable results at the specific timepoint.
Groups in this outcome
Lead-in Cohort
Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
| Group | Source count |
|---|---|
| Lead-in Cohort | 12 |
Reported measurements
C1D7
| Group | Source count |
|---|---|
| Lead-in Cohort | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 1013 | 58 | Not reported | Not reported | Not reported |
C1D15
| Group | Source count |
|---|---|
| Lead-in Cohort | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 991.4 | 57 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 58
- value
- 1013
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- title
- C1D7
- categories
- measurements
- group Id
- OG000
- spread
- 57
- value
- 991.4
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- title
- C1D15
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Maximum plasma concentration of glasdegib dosed in combination with azacitidine (C1D7) and when dosed alone (C1D15) in the Lead-in Cohort was estimated using non-compartmental analysis.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
- id
- OG000
- title
- Lead-in Cohort
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK concentration analysis set included all participants who received treatment and had at least 1 value of analyte concentration of glasdegib or azacitidine available. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = number of participants with evaluable results at the specific timepoint.
- reporting Status
- POSTED
- time Frame
- Pre-dose and 0.25, 1, 4, 6, 24 hours post-dose on Cycle 1 Day 7 and Cycle 1 Day 15
- title
- Maximum Plasma Concentration (Cmax) of Glasdegib Dosed in Combination With Azacitidine (C1D7) and When Dosed Alone (C1D15) in the Lead-in Cohort
- type
- SECONDARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice