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NCT01609556 · OUTCOME

Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 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
hours
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, total M9346A antibody, DM4, and S-methyl DM4 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 AIBW142
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW119.422.58Not reportedNot reportedNot reported
Mirvetuximab soravtansine at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW90
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW127.834.11Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW142
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW186.754.04Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW90
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW218.871.46Not reportedNot reportedNot reported
DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW38
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW73.8028.99Not reportedNot reportedNot reported
DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW30
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW80.6226.12Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW39
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW122.225.23Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW32
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW130.423.47Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.58
        value
        119.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Mirvetuximab soravtansine at Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.11
        value
        127.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      units
      Participants
    title
    Mirvetuximab soravtansine at Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.04
        value
        186.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Total M9346A antibody at Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.46
        value
        218.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      units
      Participants
    title
    Total M9346A antibody at Cycle 3
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.99
        value
        73.80
    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
        26.12
        value
        80.62
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    DM4 at Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.23
        value
        122.2
    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
        23.47
        value
        130.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      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, total M9346A antibody, DM4, and S-methyl DM4 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
Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice