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NCT02125461 · OUTCOME

Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10

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

Measure
GEOMETRIC_MEAN
Unit
Micrograms per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.

What was measured

To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.

Analysis population: PK analysis set included all patients who received at least 1 dose of durvalumab per the protocol, for whom any post-dose data were available, and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.

Groups in this outcome

Durvalumab (MEDI4736)

Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.

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

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)473

Reported measurements

Week 0: peak concentration

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)385
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durvalumab (MEDI4736)191.0072.4Not reportedNot reportedNot reported
Week 8: trough concentration

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)289
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durvalumab (MEDI4736)120.0062.2Not reportedNot reportedNot reported
Week 24: trough concentration

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)225
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durvalumab (MEDI4736)177.0047.9Not reportedNot reportedNot reported
Week 24: peak concentration

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)207
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durvalumab (MEDI4736)373.0043.6Not reportedNot reportedNot reported
Week 48: trough concentration

Analysis denominator · Participants

GroupSource count
Durvalumab (MEDI4736)213
Values in Micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Durvalumab (MEDI4736)186.0067.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        72.4
        value
        191.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        385
      units
      Participants
    title
    Week 0: peak concentration
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.2
        value
        120.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        289
      units
      Participants
    title
    Week 8: trough concentration
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.9
        value
        177.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        225
      units
      Participants
    title
    Week 24: trough concentration
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        43.6
        value
        373.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      units
      Participants
    title
    Week 24: peak concentration
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.4
        value
        186.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        213
      units
      Participants
    title
    Week 48: trough concentration
denoms
  1. counts
    1. group Id
      OG000
      value
      473
    units
    Participants
description
To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
    id
    OG000
    title
    Durvalumab (MEDI4736)
param Type
GEOMETRIC_MEAN
population Description
PK analysis set included all patients who received at least 1 dose of durvalumab per the protocol, for whom any post-dose data were available, and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.
reporting Status
POSTED
time Frame
Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.
title
Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations
type
SECONDARY
unit Of Measure
Micrograms per milliliter

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Preserved source evidence · Not medical advice