TriangleNCT02499770 · OUTCOME
Tmax 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
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- 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 Tmax values)
What was measured
Tmax of etoposide and free and total carboplatin 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: 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 | 1.08 | Not reported | 0.90 | 2.67 | Not reported |
Etoposide Day 3 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Finding/Expansion | 1.00 | Not reported | 0.85 | 1.52 | Not reported |
Free Carboplatin Day 1 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Finding/Expansion | 0.52 | Not reported | 0.47 | 0.67 | Not reported |
Total Carboplatin Day 1 Cycle 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Finding/Expansion | 0.52 | Not reported | 0.47 | 0.67 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.90
- upper Limit
- 2.67
- value
- 1.08
- title
- Etoposide Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.85
- upper Limit
- 1.52
- value
- 1.00
- title
- Etoposide Day 3 Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.47
- upper Limit
- 0.67
- value
- 0.52
- title
- Free Carboplatin Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.47
- upper Limit
- 0.67
- value
- 0.52
- title
- Total Carboplatin Day 1 Cycle 1
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- Tmax of etoposide and free and total carboplatin 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
- Full Range
- 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
- MEDIAN
- 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 Tmax values)
- title
- Tmax of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
- type
- SECONDARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice