Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01801111 · OUTCOME

Tmax of Alectinib Metabolite

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment · Source last updated 2018-11-02

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

Measure
MEDIAN
Unit
hrs
Interval / dispersion
Full Range
Time frame
Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1

What was measured

Tmax for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.

Analysis population: Analysis was performed on PK Evaluable Population. Here, 'Number Analyzed'=number of participant evaluable for specified category.

Groups in this outcome

Alectinib

Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.

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

Analysis denominator · Participants

GroupSource count
Alectinib28

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Alectinib28
Values in hrs · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib8.03Not reported5.9711.18Not reported
Day 21

Analysis denominator · Participants

GroupSource count
Alectinib26
Values in hrs · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Alectinib7.00Not reported0.012.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.97
        upper Limit
        11.18
        value
        8.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        12.00
        value
        7.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Day 21
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
Tmax for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.
dispersion Type
Full Range
groups
  1. description
    Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
    id
    OG000
    title
    Alectinib
param Type
MEDIAN
population Description
Analysis was performed on PK Evaluable Population. Here, 'Number Analyzed'=number of participant evaluable for specified category.
reporting Status
POSTED
time Frame
Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1
title
Tmax of Alectinib Metabolite
type
SECONDARY
unit Of Measure
hrs

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

Preserved source evidence · Not medical advice