TriangleNCT02499770 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of 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
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle
What was measured
Cmax 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. For estimation of Cmax, a concentration that was below the limit of quantification (BLQ) was assigned a value of zero if it occurred in a profile before the first measurable concentration. If a BLQ value occurred after a measurable concentration in a profile, and was followed by a value above the lower limit of quantification, then the BLQ was treated as missing data. If a BLQ value occurred at the end of the collection interval (after the last quantifiable concentration) it was treated as missing data. If two BLQ values occurred in succession after Cmax, the profile was deemed to have terminated at the first BLQ value and any subsequent concentrations were omitted.
Analysis population: Pharmacokinetic (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 | 1240 | 738 | Not reported | Not reported | Not reported |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 1570 | NA | Not reported | Not reported | Not calculable |
Day 3 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cohort 1 Trilaciclib 200 mg/m^2 | 1620 | 1040 | Not reported | Not reported | Not reported |
| Part 1: Cohort 2 Trilaciclib 240mg/m^2 | 2260 | NA | Not reported | Not reported | Not calculable |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 738
- value
- 1240
- comment
- Not calculable
- group Id
- OG001
- spread
- NA
- value
- 1570
- title
- Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 1040
- value
- 1620
- comment
- Not calculable
- group Id
- OG001
- spread
- NA
- value
- 2260
- title
- Day 3 Cycle 1
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Cmax 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. For estimation of Cmax, a concentration that was below the limit of quantification (BLQ) was assigned a value of zero if it occurred in a profile before the first measurable concentration. If a BLQ value occurred after a measurable concentration in a profile, and was followed by a value above the lower limit of quantification, then the BLQ was treated as missing data. If a BLQ value occurred at the end of the collection interval (after the last quantifiable concentration) it was treated as missing data. If two BLQ values occurred in succession after Cmax, the profile was deemed to have terminated at the first BLQ value and any subsequent concentrations were omitted.
- 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
- Pharmacokinetic (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
- Maximum Observed Plasma Concentration (Cmax) of Trilaciclib in Cycle 1, Part 1
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice