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NCT03219333 · OUTCOME

PK Parameter for Free MMAE: AUC (Plasma)

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer · Source last updated 2024-08-27

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

Measure
GEOMETRIC_MEAN
Unit
Day*nanogram per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)

What was measured

AUC was derived from the PK blood samples collected.

Analysis population: PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints.

Groups in this outcome

Enfortumab Vedotin - Cohort 1

Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

Enfortumab Vedotin - Cohort 2

Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1117
Enfortumab Vedotin - Cohort 284

Reported measurements

7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1115
Enfortumab Vedotin - Cohort 284
Values in Day*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 114.181.7Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 213.064.1Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 1, Day 8

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 188
Enfortumab Vedotin - Cohort 266
Values in Day*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 119.179.1Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 218.165.0Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1104
Enfortumab Vedotin - Cohort 272
Values in Day*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 111.358.0Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 210.665.0Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 2, Day 8

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 188
Enfortumab Vedotin - Cohort 257
Values in Day*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 114.964.7Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 215.360.2Not reportedNot reportedNot reported
14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 191
Enfortumab Vedotin - Cohort 262
Values in Day*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 125.974.7Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 222.676.4Not reportedNot reportedNot reported
AUC(d0-14) - Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 184
Enfortumab Vedotin - Cohort 263
Values in Day*nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 119.161.2Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 221.365.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        81.7
        value
        14.1
      2. group Id
        OG001
        spread
        64.1
        value
        13.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        84
      units
      Participants
    title
    7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        79.1
        value
        19.1
      2. group Id
        OG001
        spread
        65.0
        value
        18.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    AUC(d0-7) - Cycle 1, Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.0
        value
        11.3
      2. group Id
        OG001
        spread
        65.0
        value
        10.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        72
      units
      Participants
    title
    AUC(d0-7) - Cycle 2, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.7
        value
        14.9
      2. group Id
        OG001
        spread
        60.2
        value
        15.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        57
      units
      Participants
    title
    AUC(d0-7) - Cycle 2, Day 8
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.7
        value
        25.9
      2. group Id
        OG001
        spread
        76.4
        value
        22.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.2
        value
        19.1
      2. group Id
        OG001
        spread
        65.0
        value
        21.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        63
      units
      Participants
    title
    AUC(d0-14) - Cycle 2, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      84
    units
    Participants
description
AUC was derived from the PK blood samples collected.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    OG000
    title
    Enfortumab Vedotin - Cohort 1
  2. description
    Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
    id
    OG001
    title
    Enfortumab Vedotin - Cohort 2
param Type
GEOMETRIC_MEAN
population Description
PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints.
reporting Status
POSTED
time Frame
AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)
title
PK Parameter for Free MMAE: AUC (Plasma)
type
SECONDARY
unit Of Measure
Day*nanogram per milliliter

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Preserved source evidence · Not medical advice