TriangleNCT02499770 · OUTCOME
Cmax of Etoposide and Free and Total Carboplatin 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
- μg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1 and 3 of Cycle 1 for a 21-day cycle (carboplatin was only dosed on Day 1 so there are no Day 3 Cmax values)
What was measured
Cmax of etoposide and free and total carboplatin in plasma were 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 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: PK analysis set - included all participants with evaluable PK profiles for both treatments and analytes
Groups in this outcome
Part 1: Dose Finding/Expansion
The 1st cohort in Part 1 received trilaciclib 200 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 \& the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m\^2 was given IV daily on Days 1, 2, \& 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours \& between the dose of trilaciclib \& the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours
| Group | Source count |
|---|---|
| Part 1: Dose Finding/Expansion | 9 |
Reported measurements
Etoposide Day 1 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Finding/Expansion | 21.9 | 2.70 | Not reported | Not reported | Not reported |
Etoposide Day 3 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Finding/Expansion | 20.2 | 2.40 | Not reported | Not reported | Not reported |
Free Carboplatin Day 1 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Finding/Expansion | 20.3 | 6.83 | Not reported | Not reported | Not reported |
Total Carboplatin Day 1 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Finding/Expansion | 18.8 | 5.45 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.70
- value
- 21.9
- title
- Etoposide Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 2.40
- value
- 20.2
- title
- Etoposide Day 3 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 6.83
- value
- 20.3
- title
- Free Carboplatin Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 5.45
- value
- 18.8
- title
- Total Carboplatin Day 1 Cycle 1
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- Cmax of etoposide and free and total carboplatin in plasma were 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 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
- The 1st cohort in Part 1 received trilaciclib 200 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 \& the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m\^2 was given IV daily on Days 1, 2, \& 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours \& between the dose of trilaciclib \& the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours
- id
- OG000
- title
- Part 1: Dose Finding/Expansion
- 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 (carboplatin was only dosed on Day 1 so there are no Day 3 Cmax values)
- title
- Cmax of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
- type
- SECONDARY
- unit Of Measure
- μg/mL
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Preserved source evidence · Not medical advice