NCT02763579 · OUTCOME
Plasma Concentration of Etoposide in the Global Population
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC) · Source last updated 2023-07-28
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
- Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
What was measured
Plasma concentration of etoposide in the Global Population.
Analysis population: PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
Groups in this outcome
Placebo + Carboplatin + Etoposide
Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Atezolizumab + Carboplatin + Etoposide
Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
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 |
|---|
| Placebo + Carboplatin + Etoposide | 13 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 13 |
|---|
Reported measurements
Pre-Dose on Day 1 of Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 12 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 13 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | NA | NA | Not reported | Not reported | Below level of detection. |
|---|
| Atezolizumab + Carboplatin + Etoposide | NA | NA | Not reported | Not reported | Below level of detection. |
|---|
Before End of Infusion on Day 1 of Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 10 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 10 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | 17000 | 3640 | Not reported | Not reported | Not reported |
|---|
| Atezolizumab + Carboplatin + Etoposide | 19400 | 2860 | Not reported | Not reported | Not reported |
|---|
1 Hour Post Infusion on Day 1 of Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 8 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 12 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | 11100 | 2010 | Not reported | Not reported | Not reported |
|---|
| Atezolizumab + Carboplatin + Etoposide | 12600 | 1960 | Not reported | Not reported | Not reported |
|---|
4 Hours Post Infusion on Day 1 of Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 9 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 9 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | 7640 | 2360 | Not reported | Not reported | Not reported |
|---|
| Atezolizumab + Carboplatin + Etoposide | 7300 | 1230 | Not reported | Not reported | Not reported |
|---|
Pre-Dose on Day 1 of Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 13 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 13 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | NA | NA | Not reported | Not reported | Below level of detection. |
|---|
| Atezolizumab + Carboplatin + Etoposide | NA | NA | Not reported | Not reported | Below level of detection. |
|---|
Before End of Infusion on Day 1 of Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 11 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 9 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | 16600 | 2180 | Not reported | Not reported | Not reported |
|---|
| Atezolizumab + Carboplatin + Etoposide | 17700 | 3600 | Not reported | Not reported | Not reported |
|---|
1 Hour Post Infusion on Day 1 of Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 10 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 13 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | 12400 | 3740 | Not reported | Not reported | Not reported |
|---|
| Atezolizumab + Carboplatin + Etoposide | 12200 | 2810 | Not reported | Not reported | Not reported |
|---|
4 Hours Post Infusion on Day 1 of Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo + Carboplatin + Etoposide | 10 |
|---|
| Atezolizumab + Carboplatin + Etoposide | 11 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo + Carboplatin + Etoposide | 6740 | 1230 | Not reported | Not reported | Not reported |
|---|
| Atezolizumab + Carboplatin + Etoposide | 7960 | 2090 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Below level of detection.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Below level of detection.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Pre-Dose on Day 1 of Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 3640
- value
- 17000
- group Id
- OG001
- spread
- 2860
- value
- 19400
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- Before End of Infusion on Day 1 of Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 2010
- value
- 11100
- group Id
- OG001
- spread
- 1960
- value
- 12600
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- 1 Hour Post Infusion on Day 1 of Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 2360
- value
- 7640
- group Id
- OG001
- spread
- 1230
- value
- 7300
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- 4 Hours Post Infusion on Day 1 of Cycle 1
- categories
- measurements
- comment
- Below level of detection.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Below level of detection.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Pre-Dose on Day 1 of Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 2180
- value
- 16600
- group Id
- OG001
- spread
- 3600
- value
- 17700
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Before End of Infusion on Day 1 of Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 3740
- value
- 12400
- group Id
- OG001
- spread
- 2810
- value
- 12200
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- 1 Hour Post Infusion on Day 1 of Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 1230
- value
- 6740
- group Id
- OG001
- spread
- 2090
- value
- 7960
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- 4 Hours Post Infusion on Day 1 of Cycle 3
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Plasma concentration of etoposide in the Global Population.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- id
- OG000
- title
- Placebo + Carboplatin + Etoposide
- description
- Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
- id
- OG001
- title
- Atezolizumab + Carboplatin + Etoposide
- param Type
- MEAN
- population Description
- PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
- reporting Status
- POSTED
- time Frame
- Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
- title
- Plasma Concentration of Etoposide in the Global Population
- type
- SECONDARY
- unit Of Measure
- ng/mL
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