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NCT00585195 · OUTCOME

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib Alone and When Taken With Rifampin

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, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)

What was measured

Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau).

Analysis population: PK parameter population was defined as all participants in the Rifampin interaction cohort safety population who satisfied following criteria for Cycle 1 Day 15 or Cycle 2 Day 1: a) had at least 1 of the primary PK parameters of Crizotinib (AUCtau and Cmax). b) received adequate dosing prior to PK sampling. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.

Groups in this outcome

RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg Alone

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days).

RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) form Cycle 1Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after a meal.

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: Rifampin Interaction: Crizotinib 250 mg Alone10
RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin7

Reported measurements

Source class 1
Values in nanogram*hour per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg Alone311049Not reportedNot reportedNot reported
RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin509.635Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    10.89
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    22.26
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Ratio of adjusted geometric mean
    param Value
    15.57
Complete source fields
analyses
  1. ci Lower Limit
    10.89
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    22.26
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Ratio of adjusted geometric mean
    param Value
    15.57
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        49
        value
        3110
      2. group Id
        OG001
        spread
        35
        value
        509.6
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau).
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food from Cycle 1 Day 1 up to 13 cycles (each cycle 28 days).
    id
    OG000
    title
    RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg Alone
  2. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) form Cycle 1Day 1 up to 13 cycles (each cycle 28 days). Participants also received commercially available Rifampin 650 mg QD from Cycle 1 Day 16 to Cycle 2 Day 1 (14 days) either one hour before or 2 hours after a meal.
    id
    OG001
    title
    RP2D Cohort: Rifampin Interaction: Crizotinib 250 mg With Rifampin
param Type
GEOMETRIC_MEAN
population Description
PK parameter population was defined as all participants in the Rifampin interaction cohort safety population who satisfied following criteria for Cycle 1 Day 15 or Cycle 2 Day 1: a) had at least 1 of the primary PK parameters of Crizotinib (AUCtau and Cmax). b) received adequate dosing prior to PK sampling. Here, "Overall number of participants analyzed" signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
pre-dose, 2, 4, 6, 8 and 10 hours on Cycle 1 Day 15 (Crizotinib alone arm) and Cycle 2 Day 1 (Crizotinib with Rifampin arm)
title
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib Alone and When Taken With Rifampin
type
PRIMARY
unit Of Measure
nanogram*hour per milliliter

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Preserved source evidence · Not medical advice