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NCT03219333 · OUTCOME

PK Parameter for Total Antibody (TAb): Cmax (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
Microgram per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22

What was measured

Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.

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

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1120
Enfortumab Vedotin - Cohort 287
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 126.630.4Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 226.423.4Not reportedNot reportedNot reported
Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 193
Enfortumab Vedotin - Cohort 264
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 130.922.9Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 227.325.7Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1105
Enfortumab Vedotin - Cohort 274
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 126.230.5Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 226.323.8Not reportedNot reportedNot reported
Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 195
Enfortumab Vedotin - Cohort 262
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 130.222.7Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 227.128.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.4
        value
        26.6
      2. group Id
        OG001
        spread
        23.4
        value
        26.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        120
      2. group Id
        OG001
        value
        87
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.9
        value
        30.9
      2. group Id
        OG001
        spread
        25.7
        value
        27.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        93
      2. group Id
        OG001
        value
        64
      units
      Participants
    title
    Cycle 1, Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.5
        value
        26.2
      2. group Id
        OG001
        spread
        23.8
        value
        26.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        105
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Cycle 2, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.7
        value
        30.2
      2. group Id
        OG001
        spread
        28.2
        value
        27.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Cycle 2, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      120
    2. group Id
      OG001
      value
      87
    units
    Participants
description
Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.
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
Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22
title
PK Parameter for Total Antibody (TAb): Cmax (Serum)
type
SECONDARY
unit Of Measure
Microgram per milliliter

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Preserved source evidence · Not medical advice