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NCT02075840 · OUTCOME

Area Under The Concentration-Time Curve (AUC) of Alectinib

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants · Source last updated 2026-05-29

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
Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)

Analysis population: The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.

Groups in this outcome

Alectinib

Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.

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

Analysis denominator · Participants

GroupSource count
Alectinib144

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Alectinib10
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib713104.9Not reportedNot reportedNot reported
Treatment - week 4

Analysis denominator · Participants

GroupSource count
Alectinib9
Values in hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib503047.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        104.9
        value
        713
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.2
        value
        5030
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Treatment - week 4
denoms
  1. counts
    1. group Id
      OG000
      value
      144
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG000
    title
    Alectinib
param Type
GEOMETRIC_MEAN
population Description
The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.
reporting Status
POSTED
time Frame
Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)
title
Area Under The Concentration-Time Curve (AUC) of Alectinib
type
SECONDARY
unit Of Measure
hr*ng/mL

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

Preserved source evidence · Not medical advice