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NCT02294461 · OUTCOME

Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only)

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
L/h
Interval / dispersion
Standard Error
Time frame
From the date of randomization up to 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

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
Enzalutamide10
M1- Carboxylic Acid Metabolite10
M2- N-Desmethyl Enzalutamide10
Enzalutamide Plus M210

Reported measurements

Source class 1
Values in L/h · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Enzalutamide0.3870.0774Not reportedNot reportedNot reported
M1- Carboxylic Acid MetaboliteNANANot reportedNot reportedMetabolite dose was unknown.
M2- N-Desmethyl EnzalutamideNANANot reportedNot reportedMetabolite dose was unknown.
Enzalutamide Plus M2NANANot reportedNot reportedMetabolite dose was unknown.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0774
        value
        0.387
      2. comment
        Metabolite dose was unknown.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        Metabolite dose was unknown.
        group Id
        OG002
        spread
        NA
        value
        NA
      4. comment
        Metabolite dose was unknown.
        group Id
        OG003
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      10
    units
    Participants
dispersion Type
Standard Error
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
    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.
reporting Status
POSTED
time Frame
From the date of randomization up to Multiple Dosing Day 85
title
Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only)
type
SECONDARY
unit Of Measure
L/h

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

Preserved source evidence · Not medical advice