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NCT03125902 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Paclitaxel

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)

Analysis population: PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.

Groups in this outcome

Placebo and Paclitaxel

Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Atezolizumab and Paclitaxel

Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle 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 and Paclitaxel23
Atezolizumab and Paclitaxel36

Reported measurements

C1D1 Post-Dose

Analysis denominator · Participants

GroupSource count
Placebo and Paclitaxel23
Atezolizumab and Paclitaxel36
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel518290.7Not reportedNot reportedNot reported
Atezolizumab and Paclitaxel3011501Not reportedNot reportedNot reported
C3D1 Post-Dose

Analysis denominator · Participants

GroupSource count
Placebo and Paclitaxel16
Atezolizumab and Paclitaxel26
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel666339Not reportedNot reportedNot reported
Atezolizumab and Paclitaxel2761360Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        290.7
        value
        518
      2. group Id
        OG001
        spread
        1501
        value
        301
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    C1D1 Post-Dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        339
        value
        666
      2. group Id
        OG001
        spread
        1360
        value
        276
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    C3D1 Post-Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      36
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo and Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Atezolizumab and Paclitaxel
param Type
GEOMETRIC_MEAN
population Description
PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
reporting Status
POSTED
time Frame
Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)
title
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice