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NCT01828099 · OUTCOME

AUC0-24 of LDK378

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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

Measure
GEOMETRIC_MEAN
Unit
hours*ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days

What was measured

The area under the plasma concentration-time curve calculated from time zero to 24 hours

Analysis population: The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable PK blood sample. Only the subset of participants with extensive PK collection were analyzed

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

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

Analysis denominator · Participants

GroupSource count
Ceritinib7

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Ceritinib7
Values in hours*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ceritinib2540113.1Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Ceritinib6
Values in hours*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ceritinib1660044.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        113.1
        value
        2540
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.0
        value
        16600
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
The area under the plasma concentration-time curve calculated from time zero to 24 hours
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    id
    OG000
    title
    Ceritinib
param Type
GEOMETRIC_MEAN
population Description
The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable PK blood sample. Only the subset of participants with extensive PK collection were analyzed
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days
title
AUC0-24 of LDK378
type
SECONDARY
unit Of Measure
hours*ng/mL

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

Preserved source evidence · Not medical advice