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NCT01950364 · OUTCOME

Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma · Source last updated 2016-05-11

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1: 4 hour postdose

What was measured

Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

Analysis population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.

Groups in this outcome

Brentuximab Vedotin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.

Brentuximab Vedotin + Rifampicin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.

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

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin9
Brentuximab Vedotin + Rifampicin9

Reported measurements

MMAE
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin2.27784.42089Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin1.78360.93129Not reportedNot reportedNot reported
C4
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.05470.02737Not reportedNot reportedNot reported
Brentuximab Vedotin + RifampicinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
C5
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.02540.01326Not reportedNot reportedNot reported
Brentuximab Vedotin + RifampicinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
C7
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.01950.01293Not reportedNot reportedNot reported
Brentuximab Vedotin + RifampicinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
C8
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.05570.05631Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin0.01600.00921Not reportedNot reportedNot reported
C13
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.01510.00752Not reportedNot reportedNot reported
Brentuximab Vedotin + RifampicinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.42089
        value
        2.2778
      2. group Id
        OG001
        spread
        0.93129
        value
        1.7836
    title
    MMAE
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.02737
        value
        0.0547
      2. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    C4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.01326
        value
        0.0254
      2. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    C5
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.01293
        value
        0.0195
      2. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    C7
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.05631
        value
        0.0557
      2. group Id
        OG001
        spread
        0.00921
        value
        0.0160
    title
    C8
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.00752
        value
        0.0151
      2. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    C13
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
dispersion Type
Standard Deviation
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
    id
    OG000
    title
    Brentuximab Vedotin
  2. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
    id
    OG001
    title
    Brentuximab Vedotin + Rifampicin
param Type
GEOMETRIC_MEAN
population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
reporting Status
POSTED
time Frame
Cycle 1: 4 hour postdose
title
Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
type
PRIMARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice