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NCT01647711 · OUTCOME

Cmax of Afatinib on Day 3 of Course 1

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations · Source last updated 2017-01-31

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
47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)

What was measured

Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A

Analysis population: Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.

Groups in this outcome

Afatinib 90mg

Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

Afatinib 120mg

Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

Afatinib 150mg

Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

Afatinib 160mg

Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

Afatinib 200mg

Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Afatinib 90mg6
Afatinib 120mg3
Afatinib 150mg8
Afatinib 160mg8
Afatinib 200mg5

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Afatinib 90mg12946.2Not reportedNot reportedNot reported
Afatinib 120mg15586.9Not reportedNot reportedNot reported
Afatinib 150mg31158.8Not reportedNot reportedNot reported
Afatinib 160mg31335.6Not reportedNot reportedNot reported
Afatinib 200mg46150.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.2
        value
        129
      2. group Id
        OG001
        spread
        86.9
        value
        155
      3. group Id
        OG002
        spread
        58.8
        value
        311
      4. group Id
        OG003
        spread
        35.6
        value
        313
      5. group Id
        OG004
        spread
        50.3
        value
        461
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      5
    units
    Participants
description
Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    OG000
    title
    Afatinib 90mg
  2. description
    Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    OG001
    title
    Afatinib 120mg
  3. description
    Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    OG002
    title
    Afatinib 150mg
  4. description
    Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    OG003
    title
    Afatinib 160mg
  5. description
    Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
    id
    OG004
    title
    Afatinib 200mg
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.
reporting Status
POSTED
time Frame
47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)
title
Cmax of Afatinib on Day 3 of Course 1
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice