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NCT01609556 · OUTCOME

Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors · Source last updated 2021-02-17

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

Measure
MEAN
Unit
Liters
Interval / dispersion
Standard Deviation
Time frame
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)

What was measured

PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

Analysis population: PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.

Groups in this outcome

Mirvetuximab Soravtansine 6.0 mg/kg AIBW

Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and 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
Mirvetuximab Soravtansine 6.0 mg/kg AIBW142

Reported measurements

Mirvetuximab soravtansine at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW141
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.1980.7422Not reportedNot reportedNot reported
Mirvetuximab soravtansine at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW87
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.1721.022Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW141
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.7440.9183Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW87
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.6711.185Not reportedNot reportedNot reported
DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW38
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW10740038770Not reportedNot reportedNot reported
DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW27
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW11430048740Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW39
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW4159027890Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW27
Values in Liters · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW4752040440Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.7422
        value
        3.198
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      units
      Participants
    title
    Mirvetuximab soravtansine at Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.022
        value
        3.172
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      units
      Participants
    title
    Mirvetuximab soravtansine at Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9183
        value
        3.744
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      units
      Participants
    title
    Total M9346A antibody at Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.185
        value
        3.671
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      units
      Participants
    title
    Total M9346A antibody at Cycle 3
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        38770
        value
        107400
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      units
      Participants
    title
    DM4 at Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        48740
        value
        114300
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    DM4 at Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        27890
        value
        41590
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    S-methyl DM4 at Cycle 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        40440
        value
        47520
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    S-methyl DM4 at Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      142
    units
    Participants
description
PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
    id
    OG000
    title
    Mirvetuximab Soravtansine 6.0 mg/kg AIBW
param Type
MEAN
population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
reporting Status
POSTED
time Frame
Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
title
Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
type
SECONDARY
unit Of Measure
Liters

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Preserved source evidence · Not medical advice