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NCT01609556 · OUTCOME

Time to Reach Maximum Observed Concentration (Tmax) 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
MEDIAN
Unit
hours
Interval / dispersion
Full Range
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 AIBW142
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.80Not reported1.224Not reported
Mirvetuximab soravtansine at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW90
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.20Not reported1.147Not reported
Total M9346A antibody at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW142
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.60Not reported1.153Not reported
Total M9346A antibody at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW90
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW3.20Not reported0.93170Not reported
DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW45
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW5.80Not reported1.7500Not reported
DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW35
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW5.00Not reported1.1670Not reported
S-methyl DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW45
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW49.0Not reported5.8500Not reported
S-methyl DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW35
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW23.0Not reported4.5670Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        24
        value
        3.80
    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
        lower Limit
        1.1
        upper Limit
        47
        value
        3.20
    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
        lower Limit
        1.1
        upper Limit
        53
        value
        3.60
    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
        lower Limit
        0.93
        upper Limit
        170
        value
        3.20
    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
        lower Limit
        1.7
        upper Limit
        500
        value
        5.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    DM4 at Cycle 1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        670
        value
        5.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      units
      Participants
    title
    DM4 at Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.8
        upper Limit
        500
        value
        49.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    S-methyl DM4 at Cycle 1
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.5
        upper Limit
        670
        value
        23.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      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
Full Range
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
MEDIAN
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
Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
type
SECONDARY
unit Of Measure
hours

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice