NCT02499770 · OUTCOME
AUC0-inf of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) · Source last updated 2020-08-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- h*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 AUC0-inf values)
What was measured
AUC0-inf 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.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: Dose Finding/Expansion | 9 |
|---|
Reported measurements
Etoposide Day 1 Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: Dose Finding/Expansion | 8 |
|---|
Values in h*μg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Finding/Expansion | 131 | 44.7 | Not reported | Not reported | Not reported |
|---|
Etoposide Day 3 Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: Dose Finding/Expansion | 9 |
|---|
Values in h*μg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Finding/Expansion | 146 | 48.4 | Not reported | Not reported | Not reported |
|---|
Free Carboplatin Day 1 Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: Dose Finding/Expansion | 7 |
|---|
Values in h*μg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Finding/Expansion | 50.5 | 14.4 | Not reported | Not reported | Not reported |
|---|
Total Carboplatin Day 1 Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 1: Dose Finding/Expansion | 9 |
|---|
Values in h*μg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Dose Finding/Expansion | 137 | 37.3 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 44.7
- value
- 131
- title
- Etoposide Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 48.4
- value
- 146
- title
- Etoposide Day 3 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 14.4
- value
- 50.5
- title
- Free Carboplatin Day 1 Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 37.3
- value
- 137
- title
- Total Carboplatin Day 1 Cycle 1
- description
- AUC0-inf 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.
- 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 AUC0-inf values)
- title
- AUC0-inf of Etoposide and Free and Total Carboplatin in Cycle 1, Part 1
- type
- SECONDARY
- unit Of Measure
- h*μg/mL
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Preserved source evidence · Not medical advice
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