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NCT01871805 · OUTCOME

Ctrough After Multiple Dose of Alectinib: Phase II

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2018-08-21

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 (1 cycle = 21 days)

Analysis population: Phase II PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.

Groups in this outcome

Alectinib 600 mg (Fed): Phase II

Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.

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

Analysis denominator · Participants

GroupSource count
Alectinib 600 mg (Fed): Phase II61

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Alectinib 600 mg (Fed): Phase II61
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Alectinib 600 mg (Fed): Phase II473277Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Alectinib 600 mg (Fed): Phase II51
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Alectinib 600 mg (Fed): Phase II521272Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Alectinib 600 mg (Fed): Phase II52
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Alectinib 600 mg (Fed): Phase II538279Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Alectinib 600 mg (Fed): Phase II45
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Alectinib 600 mg (Fed): Phase II538226Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        277
        value
        473
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        272
        value
        521
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        279
        value
        538
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        226
        value
        538
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Cycle 5 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
    id
    OG000
    title
    Alectinib 600 mg (Fed): Phase II
param Type
MEAN
population Description
Phase II PK evaluable population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.
reporting Status
POSTED
time Frame
Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 (1 cycle = 21 days)
title
Ctrough After Multiple Dose of Alectinib: Phase II
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice