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NCT02294461 · OUTCOME

Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) 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
MEAN
Unit
micrograms/milliliter (μg/mL)
Interval / dispersion
Standard Deviation
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

Not reported

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 micrograms/milliliter (μg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enzalutamide3.921.37Not reportedNot reportedNot reported
M1- Carboxylic Acid Metabolite0.1120.0794Not reportedNot reportedNot reported
M2- N-Desmethyl Enzalutamide0.1750.0921Not reportedNot reportedNot reported
Enzalutamide Plus M23.941.34Not reportedNot reportedNot reported
Day 85

Analysis denominator · Participants

GroupSource count
Enzalutamide11
M1- Carboxylic Acid Metabolite11
M2- N-Desmethyl Enzalutamide11
Enzalutamide Plus M211
Values in micrograms/milliliter (μg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enzalutamide20.03.22Not reportedNot reportedNot reported
M1- Carboxylic Acid Metabolite14.023.5Not reportedNot reportedNot reported
M2- N-Desmethyl Enzalutamide15.23.44Not reportedNot reportedNot reported
Enzalutamide Plus M234.24.98Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.37
        value
        3.92
      2. group Id
        OG001
        spread
        0.0794
        value
        0.112
      3. group Id
        OG002
        spread
        0.0921
        value
        0.175
      4. group Id
        OG003
        spread
        1.34
        value
        3.94
    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
        spread
        3.22
        value
        20.0
      2. group Id
        OG001
        spread
        23.5
        value
        14.0
      3. group Id
        OG002
        spread
        3.44
        value
        15.2
      4. group Id
        OG003
        spread
        4.98
        value
        34.2
    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
Standard Deviation
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. id
    OG003
    title
    Enzalutamide Plus M2
param Type
MEAN
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
Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2
type
SECONDARY
unit Of Measure
micrograms/milliliter (μg/mL)

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

Preserved source evidence · Not medical advice