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NCT01950364 · OUTCOME

Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours 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
Interval / dispersion
Standard Deviation
Time frame
Cycle 1: 336-360 hours postdose

What was measured

Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration 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 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1.07270.55233Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin1.33260.80959Not reportedNot reportedNot reported
C4
Values in ng · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.04590.01530Not 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 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.02890.00963Not 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 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab VedotinNANANot 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.
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 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin0.07510.04505Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin0.04010.02242Not reportedNot reportedNot reported
C13
Values in ng · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab VedotinNANANot 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.
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
        0.55233
        value
        1.0727
      2. group Id
        OG001
        spread
        0.80959
        value
        1.3326
    title
    MMAE
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.01530
        value
        0.0459
      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
        0.00963
        value
        0.0289
      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. 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
        OG000
        spread
        NA
        value
        NA
      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
        0.04505
        value
        0.0751
      2. group Id
        OG001
        spread
        0.02242
        value
        0.0401
    title
    C8
  6. categories
    1. measurements
      1. 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
        OG000
        spread
        NA
        value
        NA
      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. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration 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: 336-360 hours postdose
title
Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
type
PRIMARY
unit Of Measure
ng

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Preserved source evidence · Not medical advice