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NCT00585195 · OUTCOME

RP2D Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Crizotinib When Taken With Food

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer · Source last updated 2023-02-08

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

Measure
GEOMETRIC_MEAN
Unit
nanogram*hour per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7

What was measured

AUC0-24 of Crizotinib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.

Analysis population: The food effect analysis set included all participants treated (including Day -7 dose) and in the RP2D cohort who had received a dose of crizotinib under fed conditions and for which at least 1 PK parameter of interest (Cmax or AUC) was available. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.

Groups in this outcome

RP2D Cohort: Crizotinib 250 mg With Food

Participants who were enrolled in enriched RP2D cohort received single dose of Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally with food on Day -7.

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

Analysis denominator · Participants

GroupSource count
RP2D Cohort: Crizotinib 250 mg With Food8

Reported measurements

Source class 1
Values in nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RP2D Cohort: Crizotinib 250 mg With Food1212.8646Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        46
        value
        1212.86
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
AUC0-24 of Crizotinib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants who were enrolled in enriched RP2D cohort received single dose of Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally with food on Day -7.
    id
    OG000
    title
    RP2D Cohort: Crizotinib 250 mg With Food
param Type
GEOMETRIC_MEAN
population Description
The food effect analysis set included all participants treated (including Day -7 dose) and in the RP2D cohort who had received a dose of crizotinib under fed conditions and for which at least 1 PK parameter of interest (Cmax or AUC) was available. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
pre-dose, 1, 2, 4, 6, 8, 9, and 24 hours post-dose on Day -7
title
RP2D Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Crizotinib When Taken With Food
type
PRIMARY
unit Of Measure
nanogram*hour per milliliter

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

Preserved source evidence · Not medical advice