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NCT01801111 · OUTCOME

Metabolite to Parent Ratio Based on AUC(0-10)

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
GEOMETRIC_MEAN
Unit
Ratio
Interval / dispersion
Geometric Coefficient of Variation
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

Metabolite to parent ratio based on AUC(0-10) was computed as AUC(0-10) of metabolite divided by AUC(0-10) of parent drug (alectinib) corrected for the molecular weight of parent divided by the molecular weight of the metabolite.

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 Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib0.27841.0Not reportedNot reportedNot reported
Day 21

Analysis denominator · Participants

GroupSource count
Alectinib26
Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Alectinib0.34928.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.0
        value
        0.278
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.7
        value
        0.349
    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
Metabolite to parent ratio based on AUC(0-10) was computed as AUC(0-10) of metabolite divided by AUC(0-10) of parent drug (alectinib) corrected for the molecular weight of parent divided by the molecular weight of the metabolite.
dispersion Type
Geometric Coefficient of Variation
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
GEOMETRIC_MEAN
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
Metabolite to Parent Ratio Based on AUC(0-10)
type
SECONDARY
unit Of Measure
Ratio

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

Preserved source evidence · Not medical advice