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NCT01609556 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine 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
micrograms per milliliter (mcg/mL)
Interval / dispersion
Standard Deviation
Time frame
Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [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

Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine 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 AIBW142
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW146.930.14Not reportedNot reportedNot reported
Mirvetuximab soravtansine at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW90
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW154.633.08Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW142
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW149.233.74Not reportedNot reportedNot reported
Total M9346A antibody at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW90
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW170.440.55Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.14
        value
        146.9
    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
        33.08
        value
        154.6
    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
        33.74
        value
        149.2
    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
        40.55
        value
        170.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      units
      Participants
    title
    Total M9346A antibody at Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      142
    units
    Participants
description
Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine 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 minutes [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
Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
type
SECONDARY
unit Of Measure
micrograms per milliliter (mcg/mL)

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Preserved source evidence · Not medical advice