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NCT01154140 · OUTCOME

Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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

Measure
GEOMETRIC_MEAN
Unit
nanogram per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose at Day 1 of Cycle 2, 3 and 5

What was measured

Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.

Analysis population: Pharmacokinetic concentration population included all participants in the safety analysis population who had at least 1 plasma concentration of crizotinib or its metabolite.N=participants evaluable for this measure.Number of participants analyzed(n)=participants evaluable at specified time points.This analysis was performed in crizotinib arm only.

Groups in this outcome

Crizotinib

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

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

Analysis denominator · Participants

GroupSource count
Crizotinib162

Reported measurements

Crizotinib Ctrough: Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Crizotinib91
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Crizotinib324.239Not reportedNot reportedNot reported
Crizotinib Ctrough: Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Crizotinib85
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Crizotinib320.940Not reportedNot reportedNot reported
Crizotinib Ctrough: Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Crizotinib82
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Crizotinib308.239Not reportedNot reportedNot reported
PF-06260182 Ctrough: Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Crizotinib100
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Crizotinib98.446Not reportedNot reportedNot reported
PF-06260182 Ctrough: Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Crizotinib94
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Crizotinib99.049Not reportedNot reportedNot reported
PF-06260182 Ctrough: Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Crizotinib86
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Crizotinib92.955Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        39
        value
        324.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      units
      Participants
    title
    Crizotinib Ctrough: Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        40
        value
        320.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      units
      Participants
    title
    Crizotinib Ctrough: Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        39
        value
        308.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      units
      Participants
    title
    Crizotinib Ctrough: Cycle 5 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        46
        value
        98.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      units
      Participants
    title
    PF-06260182 Ctrough: Cycle 2 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        49
        value
        99.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      units
      Participants
    title
    PF-06260182 Ctrough: Cycle 3 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        55
        value
        92.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      units
      Participants
    title
    PF-06260182 Ctrough: Cycle 5 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      162
    units
    Participants
description
Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
    id
    OG000
    title
    Crizotinib
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic concentration population included all participants in the safety analysis population who had at least 1 plasma concentration of crizotinib or its metabolite.N=participants evaluable for this measure.Number of participants analyzed(n)=participants evaluable at specified time points.This analysis was performed in crizotinib arm only.
reporting Status
POSTED
time Frame
Predose at Day 1 of Cycle 2, 3 and 5
title
Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182
type
SECONDARY
unit Of Measure
nanogram per milliliter

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

Preserved source evidence · Not medical advice