NCT02366143 · OUTCOME
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23
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 (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)
Analysis population: The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.
Groups in this outcome
Arm A (Atezolizumab+Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
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 |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 28 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 35 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 24 |
|---|
Reported measurements
Cy1D1 Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 28 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 35 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 24 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | NA | NA | Not reported | Not reported | Predose of Cycle 1 Day 1 administration of Paclitaxel. |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | NA | NA | Not reported | Not reported | Predose of Cycle 1 Day 1 administration of Paclitaxel. |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | NA | NA | Not reported | Not reported | Predose of Cycle 1 Day 1 administration of Paclitaxel. |
|---|
Cy1D1 Before End of Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 26 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 34 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 24 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 4850 | 2800 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 6440 | 3640 | Not reported | Not reported | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 5560 | 2590 | Not reported | Not reported | Not reported |
|---|
Cy1D1 After Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 27 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 32 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 23 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 2300 | 2790 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 2490 | 3020 | Not reported | Not reported | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 1980 | 1780 | Not reported | Not reported | Not reported |
|---|
Cy2D21
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 2 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 3 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 0 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | NA | NA | Not reported | Not reported | Mean or SD is not reported because more than half of the samples at the specified timepoint are below the limit of quantification. |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | NA | NA | Not reported | Not reported | Mean or SD is not reported because more than half of the samples at the specified timepoint are below the limit of quantification. |
|---|
Cy3D1 Before End Of Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 19 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 25 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 16 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 5810 | 3610 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 7810 | 4510 | Not reported | Not reported | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 7810 | 5160 | Not reported | Not reported | Not reported |
|---|
Cy3D1 After Infusion
Analysis denominator · Participants
| Group | Source count |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 19 |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 27 |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 17 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A (Atezolizumab+Paclitaxel+Carboplatin) | 1800 | 1660 | Not reported | Not reported | Not reported |
|---|
| Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin) | 2990 | 5830 | Not reported | Not reported | Not reported |
|---|
| Arm C (Bevacizumab+Paclitaxel+Carboplatin) | 1930 | 1380 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Predose of Cycle 1 Day 1 administration of Paclitaxel.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Predose of Cycle 1 Day 1 administration of Paclitaxel.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Predose of Cycle 1 Day 1 administration of Paclitaxel.
- group Id
- OG002
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Cy1D1 Pre-dose
- categories
- measurements
- group Id
- OG000
- spread
- 2800
- value
- 4850
- group Id
- OG001
- spread
- 3640
- value
- 6440
- group Id
- OG002
- spread
- 2590
- value
- 5560
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Cy1D1 Before End of Infusion
- categories
- measurements
- group Id
- OG000
- spread
- 2790
- value
- 2300
- group Id
- OG001
- spread
- 3020
- value
- 2490
- group Id
- OG002
- spread
- 1780
- value
- 1980
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Cy1D1 After Infusion
- categories
- measurements
- comment
- Mean or SD is not reported because more than half of the samples at the specified timepoint are below the limit of quantification.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Mean or SD is not reported because more than half of the samples at the specified timepoint are below the limit of quantification.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cy2D21
- categories
- measurements
- group Id
- OG000
- spread
- 3610
- value
- 5810
- group Id
- OG001
- spread
- 4510
- value
- 7810
- group Id
- OG002
- spread
- 5160
- value
- 7810
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- Cy3D1 Before End Of Infusion
- categories
- measurements
- group Id
- OG000
- spread
- 1660
- value
- 1800
- group Id
- OG001
- spread
- 5830
- value
- 2990
- group Id
- OG002
- spread
- 1380
- value
- 1930
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 17
- units
- Participants
- title
- Cy3D1 After Infusion
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 24
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
- id
- OG000
- title
- Arm A (Atezolizumab+Paclitaxel+Carboplatin)
- description
- Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
- id
- OG001
- title
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- description
- Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
- id
- OG002
- title
- Arm C (Bevacizumab+Paclitaxel+Carboplatin)
- param Type
- MEAN
- population Description
- The pharmacokinetic-evaluable population is defined as all patients who received any dose of atezolizumab, bevacizumab, carboplatin, or paclitaxel and who had evaluable PK samples post-dose.
- reporting Status
- POSTED
- time Frame
- Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)
- title
- Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice
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