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NCT02294461 · OUTCOME

AUC From the Time of Dosing to 24 h After Dosing (AUC24h) 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
μg*h/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. Number of participants analyzed is the number of participants with available data at this 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

Source class 1
Values in μg*h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enzalutamide43.19.64Not reportedNot reportedNot reported
M1- Carboxylic Acid Metabolite1.810.972Not reportedNot reportedNot reported
M2- N-Desmethyl Enzalutamide2.171.30Not reportedNot reportedNot reported
Enzalutamide Plus M245.310.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.64
        value
        43.1
      2. group Id
        OG001
        spread
        0.972
        value
        1.81
      3. group Id
        OG002
        spread
        1.30
        value
        2.17
      4. group Id
        OG003
        spread
        10.1
        value
        45.3
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. description
    Active metabolite
    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. Number of participants analyzed is the number of participants with available data at this time point.
reporting Status
POSTED
time Frame
From the date of randomization, Single Dosing Day 1 and Multiple Dosing Day 85
title
AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2
type
SECONDARY
unit Of Measure
μg*h/mL

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

Preserved source evidence · Not medical advice