Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00585195 · OUTCOME

Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Day -7

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
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7

What was measured

Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).

Analysis population: PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be collected for individual arms of low and high dose escalation cohorts (excluding 'Low Dose Escalation Cohort: Crizotinib 100 mg QD' arm) and combined RP2D.

Groups in this outcome

Low Dose Escalation Cohort: Crizotinib 50 mg QD

Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 200 mg QD

Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 200 mg BID

Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 250 mg BID

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).

Low Dose Escalation Cohort: Crizotinib 300 mg BID

Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.

High Dose Escalation Cohort: Crizotinib 300 mg QD

Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 400 mg QD

Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 500 mg QD

Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 650 mg QD

Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).

High Dose Escalation Cohort: Crizotinib 800 mg QD

Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).

RP2D Cohort: Crizotinib 250 mg

Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.

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

Analysis denominator · Participants

GroupSource count
Low Dose Escalation Cohort: Crizotinib 50 mg QD3
Low Dose Escalation Cohort: Crizotinib 200 mg QD8
Low Dose Escalation Cohort: Crizotinib 200 mg BID5
Low Dose Escalation Cohort: Crizotinib 250 mg BID9
Low Dose Escalation Cohort: Crizotinib 300 mg BID1
High Dose Escalation Cohort: Crizotinib 300 mg QD6
High Dose Escalation Cohort: Crizotinib 400 mg QD5
High Dose Escalation Cohort: Crizotinib 500 mg QD3
High Dose Escalation Cohort: Crizotinib 650 mg QD6
High Dose Escalation Cohort: Crizotinib 800 mg QD8
RP2D Cohort: Crizotinib 250 mg46

Reported measurements

Source class 1
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Low Dose Escalation Cohort: Crizotinib 50 mg QD2.00Not reported1.754.08Not reported
Low Dose Escalation Cohort: Crizotinib 200 mg QD4.09Not reported1.086.00Not reported
Low Dose Escalation Cohort: Crizotinib 200 mg BID4.00Not reported4.004.08Not reported
Low Dose Escalation Cohort: Crizotinib 250 mg BID4.00Not reported1.008.95Not reported
Low Dose Escalation Cohort: Crizotinib 300 mg BID2.02Not reported2.022.02Not reported
High Dose Escalation Cohort: Crizotinib 300 mg QD4.00Not reported2.006.00Not reported
High Dose Escalation Cohort: Crizotinib 400 mg QD2.15Not reported1.006.00Not reported
High Dose Escalation Cohort: Crizotinib 500 mg QD4.00Not reported2.008.00Not reported
High Dose Escalation Cohort: Crizotinib 650 mg QD4.00Not reported1.986.00Not reported
High Dose Escalation Cohort: Crizotinib 800 mg QD4.99Not reported2.156.13Not reported
RP2D Cohort: Crizotinib 250 mg4.00Not reported2.009.33Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.75
        upper Limit
        4.08
        value
        2.00
      2. group Id
        OG001
        lower Limit
        1.08
        upper Limit
        6.00
        value
        4.09
      3. group Id
        OG002
        lower Limit
        4.00
        upper Limit
        4.08
        value
        4.00
      4. group Id
        OG003
        lower Limit
        1.00
        upper Limit
        8.95
        value
        4.00
      5. group Id
        OG004
        lower Limit
        2.02
        upper Limit
        2.02
        value
        2.02
      6. group Id
        OG005
        lower Limit
        2.00
        upper Limit
        6.00
        value
        4.00
      7. group Id
        OG006
        lower Limit
        1.00
        upper Limit
        6.00
        value
        2.15
      8. group Id
        OG007
        lower Limit
        2.00
        upper Limit
        8.00
        value
        4.00
      9. group Id
        OG008
        lower Limit
        1.98
        upper Limit
        6.00
        value
        4.00
      10. group Id
        OG009
        lower Limit
        2.15
        upper Limit
        6.13
        value
        4.99
      11. group Id
        OG010
        lower Limit
        2.00
        upper Limit
        9.33
        value
        4.00
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      8
    11. group Id
      OG010
      value
      46
    units
    Participants
description
Tmax was defined as the time to reach the observed maximum plasma concentration (Cmax).
dispersion Type
Full Range
groups
  1. description
    Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).
    id
    OG000
    title
    Low Dose Escalation Cohort: Crizotinib 50 mg QD
  2. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).
    id
    OG001
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg QD
  3. description
    Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).
    id
    OG002
    title
    Low Dose Escalation Cohort: Crizotinib 200 mg BID
  4. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).
    id
    OG003
    title
    Low Dose Escalation Cohort: Crizotinib 250 mg BID
  5. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.
    id
    OG004
    title
    Low Dose Escalation Cohort: Crizotinib 300 mg BID
  6. description
    Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG005
    title
    High Dose Escalation Cohort: Crizotinib 300 mg QD
  7. description
    Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG006
    title
    High Dose Escalation Cohort: Crizotinib 400 mg QD
  8. description
    Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG007
    title
    High Dose Escalation Cohort: Crizotinib 500 mg QD
  9. description
    Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).
    id
    OG008
    title
    High Dose Escalation Cohort: Crizotinib 650 mg QD
  10. description
    Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).
    id
    OG009
    title
    High Dose Escalation Cohort: Crizotinib 800 mg QD
  11. description
    Participants received Crizotinib 250 mg tablet/capsule (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) orally BID up to 124 months.
    id
    OG010
    title
    RP2D Cohort: Crizotinib 250 mg
param Type
MEDIAN
population Description
PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, "N" signifies participants evaluable for this OM. Data for this OM was planned to be collected for individual arms of low and high dose escalation cohorts (excluding 'Low Dose Escalation Cohort: Crizotinib 100 mg QD' arm) and combined RP2D.
reporting Status
POSTED
time Frame
Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7
title
Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib on Day -7
type
PRIMARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice