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NCT01742286 · OUTCOME

Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) · 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
GEOMETRIC_MEAN
Unit
hr*ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
0hr pre-dose, 2, 4, 6 & 24hrs post-dose

What was measured

Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time; AUC0-24h: Area under the plasma concentration-time curve t=0-24 h

Analysis population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Groups in this outcome

Fasted: Ceritinib 300 mg/m2

Participants in the fasted group who took 300 mg of ceritinib

Fasted: Ceritinib 450 mg/m2

Participants in the fasted group who took 450 mg of ceritinib

Fasted: Ceritinib 510 mg/m2

Participants in the fasted group who took 510 mg of ceritinib

Fasted: Ceritinib 560 mg/m2

Participants in the fasted group who took 560 mg of ceritinib

Fed: Ceritinib 320 mg/m2

Participants in the fed group who took 320 mg of ceritinib

Fed: Ceritinib 400 mg/m2

Participants in the fed group who took 400 mg of ceritinib

Fed: Ceritinib 500 mg/m2

Participants in the fed group who took 500 mg of ceritinib

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

Analysis denominator · Participants

GroupSource count
Fasted: Ceritinib 300 mg/m25
Fasted: Ceritinib 450 mg/m212
Fasted: Ceritinib 510 mg/m25
Fasted: Ceritinib 560 mg/m22
Fed: Ceritinib 320 mg/m23
Fed: Ceritinib 400 mg/m24
Fed: Ceritinib 500 mg/m22

Reported measurements

AUC0-24h

Analysis denominator · Participants

GroupSource count
Fasted: Ceritinib 300 mg/m25
Fasted: Ceritinib 450 mg/m27
Fasted: Ceritinib 510 mg/m22
Fasted: Ceritinib 560 mg/m22
Fed: Ceritinib 320 mg/m21
Fed: Ceritinib 400 mg/m21
Fed: Ceritinib 500 mg/m21
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 300 mg/m2816044.0Not reportedNot reportedNot reported
Fasted: Ceritinib 450 mg/m21690059.1Not reportedNot reportedNot reported
Fasted: Ceritinib 510 mg/m22100020.8Not reportedNot reportedNot reported
Fasted: Ceritinib 560 mg/m22530039.2Not reportedNot reportedNot reported
Fed: Ceritinib 320 mg/m221000.0Not reportedNot reportedNot reported
Fed: Ceritinib 400 mg/m2305000.0Not reportedNot reportedNot reported
Fed: Ceritinib 500 mg/m2165000.0Not reportedNot reportedNot reported
AUClast

Analysis denominator · Participants

GroupSource count
Fasted: Ceritinib 300 mg/m25
Fasted: Ceritinib 450 mg/m212
Fasted: Ceritinib 510 mg/m25
Fasted: Ceritinib 560 mg/m22
Fed: Ceritinib 320 mg/m23
Fed: Ceritinib 400 mg/m24
Fed: Ceritinib 500 mg/m22
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 300 mg/m2821044.3Not reportedNot reportedNot reported
Fasted: Ceritinib 450 mg/m21800050.0Not reportedNot reportedNot reported
Fasted: Ceritinib 510 mg/m21720051.2Not reportedNot reportedNot reported
Fasted: Ceritinib 560 mg/m22560039.0Not reportedNot reportedNot reported
Fed: Ceritinib 320 mg/m25840118.4Not reportedNot reportedNot reported
Fed: Ceritinib 400 mg/m2125000113.2Not reportedNot reportedNot reported
Fed: Ceritinib 500 mg/m2167001.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.0
        value
        8160
      2. group Id
        OG001
        spread
        59.1
        value
        16900
      3. group Id
        OG002
        spread
        20.8
        value
        21000
      4. group Id
        OG003
        spread
        39.2
        value
        25300
      5. group Id
        OG004
        spread
        0.0
        value
        2100
      6. group Id
        OG005
        spread
        0.0
        value
        30500
      7. group Id
        OG006
        spread
        0.0
        value
        16500
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      units
      Participants
    title
    AUC0-24h
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.3
        value
        8210
      2. group Id
        OG001
        spread
        50.0
        value
        18000
      3. group Id
        OG002
        spread
        51.2
        value
        17200
      4. group Id
        OG003
        spread
        39.0
        value
        25600
      5. group Id
        OG004
        spread
        118.4
        value
        5840
      6. group Id
        OG005
        spread
        113.2
        value
        125000
      7. group Id
        OG006
        spread
        1.8
        value
        16700
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        2
      units
      Participants
    title
    AUClast
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      2
    units
    Participants
description
Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time; AUC0-24h: Area under the plasma concentration-time curve t=0-24 h
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants in the fasted group who took 300 mg of ceritinib
    id
    OG000
    title
    Fasted: Ceritinib 300 mg/m2
  2. description
    Participants in the fasted group who took 450 mg of ceritinib
    id
    OG001
    title
    Fasted: Ceritinib 450 mg/m2
  3. description
    Participants in the fasted group who took 510 mg of ceritinib
    id
    OG002
    title
    Fasted: Ceritinib 510 mg/m2
  4. description
    Participants in the fasted group who took 560 mg of ceritinib
    id
    OG003
    title
    Fasted: Ceritinib 560 mg/m2
  5. description
    Participants in the fed group who took 320 mg of ceritinib
    id
    OG004
    title
    Fed: Ceritinib 320 mg/m2
  6. description
    Participants in the fed group who took 400 mg of ceritinib
    id
    OG005
    title
    Fed: Ceritinib 400 mg/m2
  7. description
    Participants in the fed group who took 500 mg of ceritinib
    id
    OG006
    title
    Fed: Ceritinib 500 mg/m2
param Type
GEOMETRIC_MEAN
population Description
The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.
reporting Status
POSTED
time Frame
0hr pre-dose, 2, 4, 6 & 24hrs post-dose
title
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
type
SECONDARY
unit Of Measure
hr*ng/mL

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