TriangleNCT02499770 · OUTCOME
Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Trilaciclib in Cycle 1, Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- h*ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle
What was measured
AUC0-inf of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.
Analysis population: PK analysis set - included all participants with evaluable PK profiles for both treatments and analytes
Groups in this outcome
Part 1: Cohort 1 Trilaciclib 200 mg/m^2
Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
Part 1: Cohort 2 Trilaciclib 240mg/m^2
Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
| Group | Source count |
|---|---|
| Part 1: Cohort 1 Trilaciclib 200 mg/m^2 | 8 |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 1 |
Reported measurements
Day 1 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cohort 1 Trilaciclib 200 mg/m^2 | 2560 | 792 | Not reported | Not reported | Not reported |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 2280 | NA | Not reported | Not reported | Not calculable (n=1) |
Day 3 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cohort 1 Trilaciclib 200 mg/m^2 | 3110 | 693 | Not reported | Not reported | Not reported |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 2960 | NA | Not reported | Not reported | Not calculable (n=1) |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 792
- value
- 2560
- comment
- Not calculable (n=1)
- group Id
- OG001
- spread
- NA
- value
- 2280
- title
- Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 693
- value
- 3110
- comment
- Not calculable (n=1)
- group Id
- OG001
- spread
- NA
- value
- 2960
- title
- Day 3 Cycle 1
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- AUC0-inf of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG000
- title
- Part 1: Cohort 1 Trilaciclib 200 mg/m^2
- description
- Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
- id
- OG001
- title
- Part 1: Cohort 2 Trilaciclib 240mg/m^2
- param Type
- MEAN
- population Description
- PK analysis set - included all participants with evaluable PK profiles for both treatments and analytes
- reporting Status
- POSTED
- time Frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle
- title
- Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Trilaciclib in Cycle 1, Part 1
- type
- SECONDARY
- unit Of Measure
- h*ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice