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NCT01774721 · OUTCOME

Pre-dose Plasma Concentrations (Ctrough) of Dacomitinib and Its Metabolite PF-05199265

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. · Source last updated 2023-11-14

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 on Day 1 of Cycle 2, 3, 4, 5 and 6

What was measured

Trough plasma concentration was defined as the measured concentration at the end of a dosing interval at steady state (taken directly before next administration).

Analysis population: PK analysis set included all participants who were treated with dacomitinib with at least one measured plasma concentration and were dose-compliant. Dose-compliant participants were those who received 45 mg dacomitinib daily without interruptions or dose reductions for at least 14 days prior to the day of data collection. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.

Groups in this outcome

Dacomitinib

Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Dacomitinib188

Reported measurements

Cycle 2 Day 1: Dacomitinib

Analysis denominator · Participants

GroupSource count
Dacomitinib176
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib70.2427.16Not reportedNot reportedNot reported
Cycle 3 Day 1: Dacomitinib

Analysis denominator · Participants

GroupSource count
Dacomitinib143
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib68.3425.80Not reportedNot reportedNot reported
Cycle 4 Day 1: Dacomitinib

Analysis denominator · Participants

GroupSource count
Dacomitinib112
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib68.1625.49Not reportedNot reportedNot reported
Cycle 5 Day 1: Dacomitinib

Analysis denominator · Participants

GroupSource count
Dacomitinib85
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib64.5025.52Not reportedNot reportedNot reported
Cycle 6 Day 1: Dacomitinib

Analysis denominator · Participants

GroupSource count
Dacomitinib74
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib61.6822.58Not reportedNot reportedNot reported
Cycle 2 Day 1: PF-05199265

Analysis denominator · Participants

GroupSource count
Dacomitinib176
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib13.208.55Not reportedNot reportedNot reported
Cycle 3 Day 1: PF-05199265

Analysis denominator · Participants

GroupSource count
Dacomitinib143
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib14.429.10Not reportedNot reportedNot reported
Cycle 4 Day 1: PF-05199265

Analysis denominator · Participants

GroupSource count
Dacomitinib112
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib13.708.33Not reportedNot reportedNot reported
Cycle 5 Day 1: PF-05199265

Analysis denominator · Participants

GroupSource count
Dacomitinib85
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib12.486.69Not reportedNot reportedNot reported
Cycle 6 Day 1: PF-05199265

Analysis denominator · Participants

GroupSource count
Dacomitinib74
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib13.056.52Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.16
        value
        70.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        176
      units
      Participants
    title
    Cycle 2 Day 1: Dacomitinib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.80
        value
        68.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      units
      Participants
    title
    Cycle 3 Day 1: Dacomitinib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.49
        value
        68.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        112
      units
      Participants
    title
    Cycle 4 Day 1: Dacomitinib
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.52
        value
        64.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Cycle 5 Day 1: Dacomitinib
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.58
        value
        61.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    Cycle 6 Day 1: Dacomitinib
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.55
        value
        13.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        176
      units
      Participants
    title
    Cycle 2 Day 1: PF-05199265
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.10
        value
        14.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      units
      Participants
    title
    Cycle 3 Day 1: PF-05199265
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.33
        value
        13.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        112
      units
      Participants
    title
    Cycle 4 Day 1: PF-05199265
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.69
        value
        12.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Cycle 5 Day 1: PF-05199265
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.52
        value
        13.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    Cycle 6 Day 1: PF-05199265
denoms
  1. counts
    1. group Id
      OG000
      value
      188
    units
    Participants
description
Trough plasma concentration was defined as the measured concentration at the end of a dosing interval at steady state (taken directly before next administration).
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    id
    OG000
    title
    Dacomitinib
param Type
MEAN
population Description
PK analysis set included all participants who were treated with dacomitinib with at least one measured plasma concentration and were dose-compliant. Dose-compliant participants were those who received 45 mg dacomitinib daily without interruptions or dose reductions for at least 14 days prior to the day of data collection. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
reporting Status
POSTED
time Frame
Pre-dose on Day 1 of Cycle 2, 3, 4, 5 and 6
title
Pre-dose Plasma Concentrations (Ctrough) of Dacomitinib and Its Metabolite PF-05199265
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice