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NCT02294461 · OUTCOME

Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2

An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants · Source last updated 2025-10-24

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

Measure
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
From the date of randomization, Single Dosing Day 1 and Multiple Dosing Day 85

Analysis population: The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.

Groups in this outcome

Enzalutamide

Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).

M1- Carboxylic Acid Metabolite

Inactive metabolite

M2- N-Desmethyl Enzalutamide

N-desmethyl enzalutamide (active metabolite)

Enzalutamide Plus M2

Active metabolite

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

Analysis denominator · Participants

GroupSource count
Enzalutamide12
M1- Carboxylic Acid Metabolite12
M2- N-Desmethyl Enzalutamide12
Enzalutamide Plus M212

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Enzalutamide12
M1- Carboxylic Acid Metabolite12
M2- N-Desmethyl Enzalutamide12
Enzalutamide Plus M212
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enzalutamide0.975Not reported0.5006.05Not reported
M1- Carboxylic Acid Metabolite24.0Not reported0.55024.9Not reported
M2- N-Desmethyl Enzalutamide24.0Not reported0.55024.9Not reported
Enzalutamide Plus M20.975Not reported0.50024.0Not reported
Day 85

Analysis denominator · Participants

GroupSource count
Enzalutamide11
M1- Carboxylic Acid Metabolite11
M2- N-Desmethyl Enzalutamide11
Enzalutamide Plus M211
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enzalutamide1.00Not reported02.00Not reported
M1- Carboxylic Acid Metabolite1.02Not reported0.21724.1Not reported
M2- N-Desmethyl Enzalutamide0Not reported023.8Not reported
Enzalutamide Plus M20.250Not reported023.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.500
        upper Limit
        6.05
        value
        0.975
      2. group Id
        OG001
        lower Limit
        0.550
        upper Limit
        24.9
        value
        24.0
      3. group Id
        OG002
        lower Limit
        0.550
        upper Limit
        24.9
        value
        24.0
      4. group Id
        OG003
        lower Limit
        0.500
        upper Limit
        24.0
        value
        0.975
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2.00
        value
        1.00
      2. group Id
        OG001
        lower Limit
        0.217
        upper Limit
        24.1
        value
        1.02
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        23.8
        value
        0
      4. group Id
        OG003
        lower Limit
        0
        upper Limit
        23.8
        value
        0.250
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        11
      units
      Participants
    title
    Day 85
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      12
    units
    Participants
dispersion Type
Full Range
groups
  1. description
    Participants received 160 mg of enzalutamide orally once a day during double blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).
    id
    OG000
    title
    Enzalutamide
  2. description
    Inactive metabolite
    id
    OG001
    title
    M1- Carboxylic Acid Metabolite
  3. description
    N-desmethyl enzalutamide (active metabolite)
    id
    OG002
    title
    M2- N-Desmethyl Enzalutamide
  4. description
    Active metabolite
    id
    OG003
    title
    Enzalutamide Plus M2
param Type
MEDIAN
population Description
The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.
reporting Status
POSTED
time Frame
From the date of randomization, Single Dosing Day 1 and Multiple Dosing Day 85
title
Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2
type
SECONDARY
unit Of Measure
hour

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Preserved source evidence · Not medical advice