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NCT00585195 · OUTCOME

Itraconazole Cohort: Trough Plasma Concentration (Ctrough) 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 on Cycle 1 Day 15 (crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)

What was measured

Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.

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 Alone7
RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole9

Reported measurements

Source class 1
Values in nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg Alone136.036Not reportedNot reportedNot reported
RP2D Cohort: Itraconazole Interaction: Crizotinib 250 mg With Itraconazole214.030Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        36
        value
        136.0
      2. group Id
        OG001
        spread
        30
        value
        214.0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration.
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 on Cycle 1 Day 15 (crizotinib with itraconazole) and Cycle 2 Day 1 (itraconazole alone)
title
Itraconazole Cohort: Trough Plasma Concentration (Ctrough) of Crizotinib When Taken Alone and When Taken With Itraconazole
type
PRIMARY
unit Of Measure
nanogram per milliliter

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

Preserved source evidence · Not medical advice