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NCT01742286 · OUTCOME

PK Parameter: Tmax in Cycle 1 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
MEDIAN
Unit
hour (hr)
Interval / dispersion
Full Range
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. Tmax: The time to reach maximum plasma concentration

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/m210
Fasted: Ceritinib 510 mg/m23
Fasted: Ceritinib 560 mg/m21
Fed: Ceritinib 320 mg/m23
Fed: Ceritinib 400 mg/m24
Fed: Ceritinib 500 mg/m23

Reported measurements

Source class 1
Values in hour (hr) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 300 mg/m24.20Not reported1.9024.0Not reported
Fasted: Ceritinib 450 mg/m24.25Not reported0.006.10Not reported
Fasted: Ceritinib 510 mg/m24.30Not reported4.106.00Not reported
Fasted: Ceritinib 560 mg/m26.10Not reported6.106.10Not reported
Fed: Ceritinib 320 mg/m26.10Not reported5.706.30Not reported
Fed: Ceritinib 400 mg/m26.00Not reported4.306.20Not reported
Fed: Ceritinib 500 mg/m25.80Not reported4.106.10Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.90
        upper Limit
        24.0
        value
        4.20
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        6.10
        value
        4.25
      3. group Id
        OG002
        lower Limit
        4.10
        upper Limit
        6.00
        value
        4.30
      4. group Id
        OG003
        lower Limit
        6.10
        upper Limit
        6.10
        value
        6.10
      5. group Id
        OG004
        lower Limit
        5.70
        upper Limit
        6.30
        value
        6.10
      6. group Id
        OG005
        lower Limit
        4.30
        upper Limit
        6.20
        value
        6.00
      7. group Id
        OG006
        lower Limit
        4.10
        upper Limit
        6.10
        value
        5.80
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      3
    units
    Participants
description
Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration
dispersion Type
Full Range
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
MEDIAN
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
PK Parameter: Tmax in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
type
SECONDARY
unit Of Measure
hour (hr)

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

Preserved source evidence · Not medical advice