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NCT01609556 · OUTCOME

AUC0-inf of Free 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*nanograms/milliliter (hr*ng/mL)
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 free 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

DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW38
Values in hours*nanograms/milliliter (hr*ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW292.9129.2Not reportedNot reportedNot reported
DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW27
Values in hours*nanograms/milliliter (hr*ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW290.698.52Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW39
Values in hours*nanograms/milliliter (hr*ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW26562722Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW27
Values in hours*nanograms/milliliter (hr*ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW19281108Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        129.2
        value
        292.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      units
      Participants
    title
    DM4 at Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        98.52
        value
        290.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    DM4 at Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2722
        value
        2656
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    S-methyl DM4 at Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1108
        value
        1928
    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 free 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
AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D
type
SECONDARY
unit Of Measure
hours*nanograms/milliliter (hr*ng/mL)

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Preserved source evidence · Not medical advice