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NCT00585195 · OUTCOME

Itraconazole Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken Alone and When Taken With Itraconazole

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 per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)

Analysis population: PK parameter evaluable population included participants who had at least 1 of the PK parameters of Crizotinib (AUCtau or Cmax) and had received 10 consecutive doses of both Crizotinib 250 mg QD and itraconazole 200 mg QD immediately prior to end of Crizotinib 250 mg + Itraconazole treatment as well as 10 consecutive doses of Crizotinib 250 mg QD prior to end of Crizotinib 250 mg + Itraconazole treatment. Overall number of participants analyzed =participants evaluable for this outcome measure.

Groups in this outcome

RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg Alone

Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days).

RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16. (each cycle 28 days).

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: Itraconazole Interaction: Crizotinib 250 mg Alone10
RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole10

Reported measurements

Source class 1
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg Alone259.923Not reportedNot reportedNot reported
RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole353.214Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    119.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    148.10
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Ratio of adjusted geometric means
    param Value
    132.81
Complete source fields
analyses
  1. ci Lower Limit
    119.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    148.10
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Ratio of adjusted geometric means
    param Value
    132.81
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23
        value
        259.9
      2. group Id
        OG001
        spread
        14
        value
        353.2
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received with or without food Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days).
    id
    OG000
    title
    RP2D Cohort: Itraconazole 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 QD from Cycle 1Day1 to Cycle 2 Day1 thereafter 250 mg BID from Cycle 2 Day 2 up to 58 cycles (each cycle 28 days). Participants also received Itraconazole 200 mg QD from Cycle 1 Day 1 to Cycle 1 Day 16. (each cycle 28 days).
    id
    OG001
    title
    RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole
param Type
GEOMETRIC_MEAN
population Description
PK parameter evaluable population included participants who had at least 1 of the PK parameters of Crizotinib (AUCtau or Cmax) and had received 10 consecutive doses of both Crizotinib 250 mg QD and itraconazole 200 mg QD immediately prior to end of Crizotinib 250 mg + Itraconazole treatment as well as 10 consecutive doses of Crizotinib 250 mg QD prior to end of Crizotinib 250 mg + Itraconazole treatment. Overall number of participants analyzed =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 Cycle 1 Day 15 (Crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)
title
Itraconazole Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib When Taken Alone and When Taken With Itraconazole
type
PRIMARY
unit Of Measure
nanogram per milliliter

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Preserved source evidence · Not medical advice