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NCT00932893 · OUTCOME

Plasma Concentration of Crizotinib

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

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 (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5

What was measured

Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.

Analysis population: Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points.

Groups in this outcome

Crizotinib

Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

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

Analysis denominator · Participants

GroupSource count
Crizotinib152

Reported measurements

Cycle 1 Day 1 (n=15)
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CrizotinibNANANot reportedNot reportedData was not summarized since none of the participants had Ctrough values above lower limit of quantification (LLOQ).
Cycle 1 Day 15 (n=92)
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Crizotinib298148Not reportedNot reportedNot reported
Cycle 2 Day 1 (n=62)
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Crizotinib293154Not reportedNot reportedNot reported
Cycle 3 Day 1 (n=61)
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Crizotinib306135Not reportedNot reportedNot reported
Cycle 5 Day 1 (n=47)
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Crizotinib291156Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data was not summarized since none of the participants had Ctrough values above lower limit of quantification (LLOQ).
        group Id
        OG000
        spread
        NA
        value
        NA
    title
    Cycle 1 Day 1 (n=15)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        148
        value
        298
    title
    Cycle 1 Day 15 (n=92)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        154
        value
        293
    title
    Cycle 2 Day 1 (n=62)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        135
        value
        306
    title
    Cycle 3 Day 1 (n=61)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        156
        value
        291
    title
    Cycle 5 Day 1 (n=47)
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    units
    Participants
description
Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.
dispersion Type
Standard Deviation
groups
  1. description
    Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
    id
    OG000
    title
    Crizotinib
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here "N" (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points.
reporting Status
POSTED
time Frame
Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5
title
Plasma Concentration of Crizotinib
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice