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NCT01609556 · OUTCOME

AUClast 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
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 AIBW43
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW246.0133.3Not reportedNot reportedNot reported
DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW27
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW270.195.62Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 1

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW45
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW24852536Not reportedNot reportedNot reported
S-methyl DM4 at Cycle 3

Analysis denominator · Participants

GroupSource count
Mirvetuximab Soravtansine 6.0 mg/kg AIBW27
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mirvetuximab Soravtansine 6.0 mg/kg AIBW18061046Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        133.3
        value
        246.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      units
      Participants
    title
    DM4 at Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        95.62
        value
        270.1
    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
        2536
        value
        2485
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    S-methyl DM4 at Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1046
        value
        1806
    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
AUClast of Free DM4 and S-Methyl DM4 at RP2D
type
SECONDARY
unit Of Measure
hr*ng/mL

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

Preserved source evidence · Not medical advice