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NCT01774721 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) 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
nanogram per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)

What was measured

Cmax was defined as maximum observed plasma concentration and can be observed directly from data.

Analysis population: Pharmacokinetic (PK) analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.

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
Dacomitinib19

Reported measurements

Dacomitinib
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib84.1921.90Not reportedNot reportedNot reported
PF-05199265
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Dacomitinib12.777.58Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.90
        value
        84.19
    title
    Dacomitinib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.58
        value
        12.77
    title
    PF-05199265
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Cmax was defined as maximum observed plasma concentration and can be observed directly from data.
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
Pharmacokinetic (PK) analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
reporting Status
POSTED
time Frame
Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
title
Maximum Observed Plasma Concentration (Cmax) of Dacomitinib and Its Metabolite PF-05199265
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice