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NCT04325828 · OUTCOME

Plasma Concentration of N-desmethyl Apalutamide

A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma · Source last updated 2026-08-28

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

Measure
MEAN
Unit
mcg/mL
Interval / dispersion
Standard Deviation
Time frame
Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)

What was measured

Plasma concentration of N-desmethyl Apalutamide was reported.

Analysis population: Pharmacokinetics analysis set included all participants with at least 1 apalutamide and/or N-desmethyl apalutamide concentration data after the first study intervention administration. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated at specified timepoints.

Groups in this outcome

Apalutamide + Goserelin

Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.

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

Analysis denominator · Participants

GroupSource count
Apalutamide + Goserelin29

Reported measurements

Cycle 02 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Apalutamide + Goserelin29
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Apalutamide + Goserelin7.191.21Not reportedNot reportedNot reported
Cycle 03 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Apalutamide + Goserelin28
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Apalutamide + Goserelin6.891.56Not reportedNot reportedNot reported
Cycle 04 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Apalutamide + Goserelin25
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Apalutamide + Goserelin6.291.66Not reportedNot reportedNot reported
Cycle 05 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Apalutamide + Goserelin23
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Apalutamide + Goserelin6.531.81Not reportedNot reportedNot reported
Cycle 06 Day 1, Predose

Analysis denominator · Participants

GroupSource count
Apalutamide + Goserelin19
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Apalutamide + Goserelin6.401.91Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.21
        value
        7.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    Cycle 02 Day 1, Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.56
        value
        6.89
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Cycle 03 Day 1, Predose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.66
        value
        6.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Cycle 04 Day 1, Predose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.81
        value
        6.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Cycle 05 Day 1, Predose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.91
        value
        6.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      units
      Participants
    title
    Cycle 06 Day 1, Predose
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
Plasma concentration of N-desmethyl Apalutamide was reported.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with androgen receptor (AR) expressing locally advanced or recurrent/metastatic salivary gland carcinoma (SGC) received apalutamide 240 milligrams (mg) (4\*60 mg tablets) orally once daily with or without food in combination with stable regimen of goserelin 3.6 mg administered subcutaneously once per cycle (each cycle is of 28 days) as a gonadotropin-releasing hormone (GnRH) agonist, until disease progression, unacceptable toxicity, death, or end of the study.
    id
    OG000
    title
    Apalutamide + Goserelin
param Type
MEAN
population Description
Pharmacokinetics analysis set included all participants with at least 1 apalutamide and/or N-desmethyl apalutamide concentration data after the first study intervention administration. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated at specified timepoints.
reporting Status
POSTED
time Frame
Day 1 (predose) of Cycles 2 to 6 (each cycle was of 28 days)
title
Plasma Concentration of N-desmethyl Apalutamide
type
SECONDARY
unit Of Measure
mcg/mL

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Preserved source evidence · Not medical advice