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NCT01742286 · OUTCOME

Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Expansion Phase (Multiple 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. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the plasma (serum, or blood) concentration versus time curverea 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), MTD/RDE 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 510 mg/m2

Participants in the fasted group who took 510 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 510 mg/m24
Fed: Ceritinib 500 mg/m214

Reported measurements

AUC0-24h

Analysis denominator · Participants

GroupSource count
Fasted: Ceritinib 510 mg/m20
Fed: Ceritinib 500 mg/m26
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Fed: Ceritinib 500 mg/m21590093.8Not reportedNot reportedNot reported
AUClast

Analysis denominator · Participants

GroupSource count
Fasted: Ceritinib 510 mg/m24
Fed: Ceritinib 500 mg/m214
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 510 mg/m22410038.9Not reportedNot reportedNot reported
Fed: Ceritinib 500 mg/m21610061.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        93.8
        value
        15900
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    AUC0-24h
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.9
        value
        24100
      2. group Id
        OG001
        spread
        61.2
        value
        16100
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    AUClast
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the plasma (serum, or blood) concentration versus time curverea 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 510 mg of ceritinib
    id
    OG000
    title
    Fasted: Ceritinib 510 mg/m2
  2. description
    Participants in the fed group who took 500 mg of ceritinib
    id
    OG001
    title
    Fed: Ceritinib 500 mg/m2
param Type
GEOMETRIC_MEAN
population Description
The PK analysis set (PAS), MTD/RDE 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 Expansion Phase (Multiple Dose)
type
SECONDARY
unit Of Measure
hr*ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice