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NCT00939770 · OUTCOME

Steady State Clearance of Crizotinib

Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma · Source last updated 2020-06-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
mL/min/m2
Interval / dispersion
Standard Error
Time frame
Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hour post-dose

What was measured

Mean with standard deviation of the elimination of crizotinib at steady state by dose level.

Analysis population: Steady state PK sampling was not performed during enrollment on dose level 1 or 2. In Phase 2, PK was optional and for those who consented data is included with dose level 5. Steady state PK samples were obtained on a day between day 15 and 28 of cycle 1, pre-dose, 1, 2, 4, 6-8 h post-dose.

Groups in this outcome

Dose Level 3

PF-02341066 165 mg/m²/dose BID

Dose Level 4

PF-02341066 215 mg/m²/dose BID

Dose Level 5

PF-02341066 280 mg/m²/dose BID

Dose Level 6

PF-02341066 365 mg/m²/dose BID

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

Analysis denominator · Participants

GroupSource count
Dose Level 31
Dose Level 45
Dose Level 536
Dose Level 66

Reported measurements

Source class 1
Values in mL/min/m2 · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Dose Level 37350Not reportedNot reportedNot reported
Dose Level 4652159Not reportedNot reportedNot reported
Dose Level 5736255Not reportedNot reportedNot reported
Dose Level 6731223Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        735
      2. group Id
        OG001
        spread
        159
        value
        652
      3. group Id
        OG002
        spread
        255
        value
        736
      4. group Id
        OG003
        spread
        223
        value
        731
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      36
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Mean with standard deviation of the elimination of crizotinib at steady state by dose level.
dispersion Type
Standard Error
groups
  1. description
    PF-02341066 165 mg/m²/dose BID
    id
    OG000
    title
    Dose Level 3
  2. description
    PF-02341066 215 mg/m²/dose BID
    id
    OG001
    title
    Dose Level 4
  3. description
    PF-02341066 280 mg/m²/dose BID
    id
    OG002
    title
    Dose Level 5
  4. description
    PF-02341066 365 mg/m²/dose BID
    id
    OG003
    title
    Dose Level 6
param Type
MEAN
population Description
Steady state PK sampling was not performed during enrollment on dose level 1 or 2. In Phase 2, PK was optional and for those who consented data is included with dose level 5. Steady state PK samples were obtained on a day between day 15 and 28 of cycle 1, pre-dose, 1, 2, 4, 6-8 h post-dose.
reporting Status
POSTED
time Frame
Cycle 1 (day 15-28) pre-dose, 1, 2, 4, 6-8 hour post-dose
title
Steady State Clearance of Crizotinib
type
PRIMARY
unit Of Measure
mL/min/m2

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

Preserved source evidence · Not medical advice