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NCT01121588 · OUTCOME

Steady-State Pre-dose Concentration (Ctrough) for Crizotinib on Day 1 of Cycles 2, 3 and 5

Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK) · Source last updated 2025-01-23

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
Geometric Coefficient of Variation
Time frame
Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5

What was measured

Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection.

Analysis population: Number of Participants Analyzed = participants who were enrolled and treated, had at least 1 PK blood sample collected, and were evaluable for steady-state Ctrough analysis. Number Analyzed = participants evaluable for this OM and had Ctrough data on the specific day.

Groups in this outcome

ALCL Arm

In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

IMT Arm

In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

Other Tumors

In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

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

Analysis denominator · Participants

GroupSource count
ALCL Arm15
IMT Arm8
Other Tumors12

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
ALCL Arm10
IMT Arm6
Other Tumors6
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ALCL Arm27046.2Not reportedNot reportedNot reported
IMT Arm26642.0Not reportedNot reportedNot reported
Other Tumors233101Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
ALCL Arm11
IMT Arm6
Other Tumors4
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ALCL Arm31633.4Not reportedNot reportedNot reported
IMT Arm17992.1Not reportedNot reportedNot reported
Other Tumors187224Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
ALCL Arm9
IMT Arm7
Other Tumors4
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
ALCL Arm24480.0Not reportedNot reportedNot reported
IMT Arm25735.1Not reportedNot reportedNot reported
Other Tumors34763.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.2
        value
        270
      2. group Id
        OG001
        spread
        42.0
        value
        266
      3. group Id
        OG002
        spread
        101
        value
        233
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.4
        value
        316
      2. group Id
        OG001
        spread
        92.1
        value
        179
      3. group Id
        OG002
        spread
        224
        value
        187
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.0
        value
        244
      2. group Id
        OG001
        spread
        35.1
        value
        257
      3. group Id
        OG002
        spread
        63.1
        value
        347
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    Cycle 5 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      12
    units
    Participants
description
Ctrough is defined as the drug concentration observed at the last planned timepoint prior to dosing. Steady state is defined as the participant receiving at least 90% of Crizotinib 500 mg daily dosing 14 days prior to the PK sample collection.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG000
    title
    ALCL Arm
  2. description
    In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG001
    title
    IMT Arm
  3. description
    In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG002
    title
    Other Tumors
param Type
GEOMETRIC_MEAN
population Description
Number of Participants Analyzed = participants who were enrolled and treated, had at least 1 PK blood sample collected, and were evaluable for steady-state Ctrough analysis. Number Analyzed = participants evaluable for this OM and had Ctrough data on the specific day.
reporting Status
POSTED
time Frame
Predose within 1.2 hours before dosing on Day 1 of Cycles 2, 3 and 5
title
Steady-State Pre-dose Concentration (Ctrough) for Crizotinib on Day 1 of Cycles 2, 3 and 5
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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Preserved source evidence · Not medical advice