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NCT02631876 · OUTCOME

Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer · Source last updated 2020-10-14

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

Measure
MEAN
Unit
hours*milligrams/milliliter (hr*mg/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1 and 3; and Day 8 and 15 of Cycles 1 and 3

What was measured

PK parameters were calculated using standard non-compartmental methods.

Analysis population: PK population included all participants who received at least 1 infusion of mirvetuximab soravtansine, had evaluable PK data, and had samples collected with no major deviations related to administration of study drug. Here, 'number analyzed'=participants evaluable for specified categories.

Groups in this outcome

Mirvetuximab Soravtansine

Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)

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

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine235

Reported measurements

Mirvetuximab Soravtansine at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine235
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine20.5310.31Not reportedNot reportedNot reported
Mirvetuximab Soravtansine at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine146
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine22.407.770Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine235
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine23.239.463Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine146
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine31.2011.52Not reportedNot reportedNot reported
DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine233
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine348.5265.7Not reportedNot reportedNot reported
DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine142
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine347.4280.9Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine234
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine15861496Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine146
Values in hours*milligrams/milliliter (hr*mg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine15121278Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.31
        value
        20.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      units
      Participants
    title
    Mirvetuximab Soravtansine at Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.770
        value
        22.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      units
      Participants
    title
    Mirvetuximab Soravtansine at Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.463
        value
        23.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      units
      Participants
    title
    Total M9346A antibody at Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.52
        value
        31.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      units
      Participants
    title
    Total M9346A antibody at Cycle 3
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        265.7
        value
        348.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        233
      units
      Participants
    title
    DM4 at Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        280.9
        value
        347.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    DM4 at Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1496
        value
        1586
    denoms
    1. counts
      1. group Id
        OG000
        value
        234
      units
      Participants
    title
    S-methyl DM4 at Cycle 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1278
        value
        1512
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      units
      Participants
    title
    S-methyl DM4 at Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      235
    units
    Participants
description
PK parameters were calculated using standard non-compartmental methods.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
    id
    OG000
    title
    Mirvetuximab Soravtansine
param Type
MEAN
population Description
PK population included all participants who received at least 1 infusion of mirvetuximab soravtansine, had evaluable PK data, and had samples collected with no major deviations related to administration of study drug. Here, 'number analyzed'=participants evaluable for specified categories.
reporting Status
POSTED
time Frame
Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1 and 3; and Day 8 and 15 of Cycles 1 and 3
title
Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4
type
SECONDARY
unit Of Measure
hours*milligrams/milliliter (hr*mg/mL)

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Preserved source evidence · Not medical advice