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NCT03219333 · OUTCOME

PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (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
Nanogram 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, 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

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1117
Enfortumab Vedotin - Cohort 284
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 13.167.0Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 22.657.8Not reportedNot reportedNot reported
Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 193
Enfortumab Vedotin - Cohort 264
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 13.964.8Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 23.551.8Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 1106
Enfortumab Vedotin - Cohort 272
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 12.457.4Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 22.260.8Not reportedNot reportedNot reported
Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin - Cohort 190
Enfortumab Vedotin - Cohort 262
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin - Cohort 13.064.8Not reportedNot reportedNot reported
Enfortumab Vedotin - Cohort 22.959.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.0
        value
        3.1
      2. group Id
        OG001
        spread
        57.8
        value
        2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        84
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.8
        value
        3.9
      2. group Id
        OG001
        spread
        51.8
        value
        3.5
    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
        57.4
        value
        2.4
      2. group Id
        OG001
        spread
        60.8
        value
        2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        72
      units
      Participants
    title
    Cycle 2, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.8
        value
        3.0
      2. group Id
        OG001
        spread
        59.9
        value
        2.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Cycle 2, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      84
    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, 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
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 Free Monomethyl Auristatin E (MMAE): Cmax (Plasma)
type
SECONDARY
unit Of Measure
Nanogram per milliliter

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Preserved source evidence · Not medical advice