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NCT05654623 · OUTCOME

Plasma Concentration of ARV-471 and Its Epimer ARV-473

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer · Source last updated 2026-03-18

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

Measure
MEDIAN
Unit
Nanograms per milliliter
Interval / dispersion
Full Range
Time frame
Anytime between -4 to 0 hours on Day 1 of Cycle 2, Cycle 3, Cycle 5 and Cycle 7 and anytime between 5 to 7 hours on Day 1 of Cycle 2 and Cycle 3

What was measured

Plasma concentrations of ARV-471 and its epimer ARV-473 were reported in this outcome measure.

Analysis population: PK concentration set included all participants who were in the Safety Analysis Set and had at least 1 concentration of either ARV-471 or ARV-473. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for a specified timepoint.

Groups in this outcome

Vepdegestrant (ARV-471)

Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.

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

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)288

Reported measurements

ARV-471: Cycle 2 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)288
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)445.5Not reported3.051530Not reported
ARV-471: Cycle 2 Day 1 (5 to 7 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)274
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)795.5Not reported50.52260Not reported
ARV-471: Cycle 3 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)224
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)453.5Not reported11.51680Not reported
ARV-471: Cycle 3 Day 1 (5 to 7 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)211
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)743.0Not reported1512170Not reported
ARV-471: Cycle 5 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)150
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)440.5Not reported0.001370Not reported
ARV-471: Cycle 7 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)104
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)466.0Not reported18.71130Not reported
ARV-473: Cycle 2 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)288
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)193.5Not reported0.00628Not reported
ARV-473: Cycle 2 Day 1 (5 to 7 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)274
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)225.5Not reported19.3700Not reported
ARV-473: Cycle 3 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)224
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)193.0Not reported6.10611Not reported
ARV-473: Cycle 3 Day 1 (5 to 7 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)211
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)214.0Not reported26.0655Not reported
ARV-473: Cycle 5 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)150
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)188.0Not reported0.00561Not reported
ARV-473: Cycle 7 Day 1 (-4 to 0 hours)

Analysis denominator · Participants

GroupSource count
Vepdegestrant (ARV-471)104
Values in Nanograms per milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Vepdegestrant (ARV-471)186.0Not reported10.3464Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.05
        upper Limit
        1530
        value
        445.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        288
      units
      Participants
    title
    ARV-471: Cycle 2 Day 1 (-4 to 0 hours)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.5
        upper Limit
        2260
        value
        795.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        274
      units
      Participants
    title
    ARV-471: Cycle 2 Day 1 (5 to 7 hours)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.5
        upper Limit
        1680
        value
        453.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        224
      units
      Participants
    title
    ARV-471: Cycle 3 Day 1 (-4 to 0 hours)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        151
        upper Limit
        2170
        value
        743.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      units
      Participants
    title
    ARV-471: Cycle 3 Day 1 (5 to 7 hours)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        1370
        value
        440.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        150
      units
      Participants
    title
    ARV-471: Cycle 5 Day 1 (-4 to 0 hours)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.7
        upper Limit
        1130
        value
        466.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      units
      Participants
    title
    ARV-471: Cycle 7 Day 1 (-4 to 0 hours)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        628
        value
        193.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        288
      units
      Participants
    title
    ARV-473: Cycle 2 Day 1 (-4 to 0 hours)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.3
        upper Limit
        700
        value
        225.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        274
      units
      Participants
    title
    ARV-473: Cycle 2 Day 1 (5 to 7 hours)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.10
        upper Limit
        611
        value
        193.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        224
      units
      Participants
    title
    ARV-473: Cycle 3 Day 1 (-4 to 0 hours)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.0
        upper Limit
        655
        value
        214.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        211
      units
      Participants
    title
    ARV-473: Cycle 3 Day 1 (5 to 7 hours)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        561
        value
        188.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        150
      units
      Participants
    title
    ARV-473: Cycle 5 Day 1 (-4 to 0 hours)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.3
        upper Limit
        464
        value
        186.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      units
      Participants
    title
    ARV-473: Cycle 7 Day 1 (-4 to 0 hours)
denoms
  1. counts
    1. group Id
      OG000
      value
      288
    units
    Participants
description
Plasma concentrations of ARV-471 and its epimer ARV-473 were reported in this outcome measure.
dispersion Type
Full Range
groups
  1. description
    Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    OG000
    title
    Vepdegestrant (ARV-471)
param Type
MEDIAN
population Description
PK concentration set included all participants who were in the Safety Analysis Set and had at least 1 concentration of either ARV-471 or ARV-473. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable for a specified timepoint.
reporting Status
POSTED
time Frame
Anytime between -4 to 0 hours on Day 1 of Cycle 2, Cycle 3, Cycle 5 and Cycle 7 and anytime between 5 to 7 hours on Day 1 of Cycle 2 and Cycle 3
title
Plasma Concentration of ARV-471 and Its Epimer ARV-473
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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

Preserved source evidence · Not medical advice