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NCT02425891 · OUTCOME

Plasma Concentrations of Total Paclitaxel

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) · Source last updated 2022-07-19

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
Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)

What was measured

Plasma Concentrations of Total Paclitaxel

Analysis population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

Groups in this outcome

Placebo Plus Nab-Paclitaxel

Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

Atezolizumab Plus Nab-Paclitaxel

Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo Plus Nab-Paclitaxel321
Atezolizumab Plus Nab-Paclitaxel436

Reported measurements

C1D1/Predose

Analysis denominator · Participants

GroupSource count
Placebo Plus Nab-Paclitaxel321
Atezolizumab Plus Nab-Paclitaxel436
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo Plus Nab-PaclitaxelNANANot reportedNot reportedCycle 1 predose is before study drug treatment.
Atezolizumab Plus Nab-PaclitaxelNANANot reportedNot reportedCycle 1 predose is before study drug treatment.
C3D1/Predose

Analysis denominator · Participants

GroupSource count
Placebo Plus Nab-Paclitaxel310
Atezolizumab Plus Nab-Paclitaxel351
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo Plus Nab-PaclitaxelNANANot reportedNot reportedBelow the level of detection as expected given the half-life of 13-27 hours per abraxane product label.
Atezolizumab Plus Nab-PaclitaxelNANANot reportedNot reportedBelow the level of detection as expected given the half-life of 13-27 hours per abraxane product label.
C3D1/ Before End of Infusion

Analysis denominator · Participants

GroupSource count
Placebo Plus Nab-Paclitaxel255
Atezolizumab Plus Nab-Paclitaxel298
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo Plus Nab-Paclitaxel29702300Not reportedNot reportedNot reported
Atezolizumab Plus Nab-Paclitaxel30802050Not reportedNot reportedNot reported
C3D1/Postdose Paclit

Analysis denominator · Participants

GroupSource count
Placebo Plus Nab-Paclitaxel221
Atezolizumab Plus Nab-Paclitaxel280
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo Plus Nab-Paclitaxel370244Not reportedNot reportedNot reported
Atezolizumab Plus Nab-Paclitaxel400275Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Cycle 1 predose is before study drug treatment.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Cycle 1 predose is before study drug treatment.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        321
      2. group Id
        OG001
        value
        436
      units
      Participants
    title
    C1D1/Predose
  2. categories
    1. measurements
      1. comment
        Below the level of detection as expected given the half-life of 13-27 hours per abraxane product label.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Below the level of detection as expected given the half-life of 13-27 hours per abraxane product label.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        310
      2. group Id
        OG001
        value
        351
      units
      Participants
    title
    C3D1/Predose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2300
        value
        2970
      2. group Id
        OG001
        spread
        2050
        value
        3080
    denoms
    1. counts
      1. group Id
        OG000
        value
        255
      2. group Id
        OG001
        value
        298
      units
      Participants
    title
    C3D1/ Before End of Infusion
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        244
        value
        370
      2. group Id
        OG001
        spread
        275
        value
        400
    denoms
    1. counts
      1. group Id
        OG000
        value
        221
      2. group Id
        OG001
        value
        280
      units
      Participants
    title
    C3D1/Postdose Paclit
denoms
  1. counts
    1. group Id
      OG000
      value
      321
    2. group Id
      OG001
      value
      436
    units
    Participants
description
Plasma Concentrations of Total Paclitaxel
dispersion Type
Standard Deviation
groups
  1. description
    Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo Plus Nab-Paclitaxel
  2. description
    Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Atezolizumab Plus Nab-Paclitaxel
param Type
MEAN
population Description
The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.
reporting Status
POSTED
time Frame
Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)
title
Plasma Concentrations of Total Paclitaxel
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice