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NCT03219333 · OUTCOME

PK Parameter for TAb: AUC (Serum)

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*microgram 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, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. 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 1120
Enfortumab Vedotin - Cohort 287

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 285
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 163.433.6Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 266.834.3Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 1, Day 8

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 188
Enfortumab Vedotin - Cohort 263
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 177.635.2Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 272.337.9Not 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*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 173.233.5Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 272.926.4Not reportedNot reportedNot reported
AUC(d0-7) - Cycle 2, Day 8

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 188
Enfortumab Vedotin - Cohort 256
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 187.930.6Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 281.030.9Not reportedNot reportedNot reported
14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 193
Enfortumab Vedotin - Cohort 262
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 198.138.8Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 291.140.3Not reportedNot reportedNot reported
AUC(d0-14) - Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 184
Enfortumab Vedotin - Cohort 262
Values in Day*microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 1113.033.8Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 2109.741.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.6
        value
        63.4
      2. group Id
        OG001
        spread
        34.3
        value
        66.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        85
      units
      Participants
    title
    7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.2
        value
        77.6
      2. group Id
        OG001
        spread
        37.9
        value
        72.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        63
      units
      Participants
    title
    AUC(d0-7) - Cycle 1, Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.5
        value
        73.2
      2. group Id
        OG001
        spread
        26.4
        value
        72.9
    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
        30.6
        value
        87.9
      2. group Id
        OG001
        spread
        30.9
        value
        81.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    AUC(d0-7) - Cycle 2, Day 8
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.8
        value
        98.1
      2. group Id
        OG001
        spread
        40.3
        value
        91.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        93
      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
        33.8
        value
        113.0
      2. group Id
        OG001
        spread
        41.5
        value
        109.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    AUC(d0-14) - Cycle 2, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      120
    2. group Id
      OG001
      value
      87
    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, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. 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 TAb: AUC (Serum)
type
SECONDARY
unit Of Measure
Day*microgram per milliliter

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Preserved source evidence · Not medical advice