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NCT02552121 · OUTCOME

Part 1: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)

Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2021-04-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1

Analysis population: Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.

Groups in this outcome

Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg

Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg

Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg3
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg6

Reported measurements

Cycle 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg2.7623.7Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg2.8852.4Not reportedNot reportedNot reported
Cycle 1 Day 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg1.4654.7Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg1.3878.4Not reportedNot reportedNot reported
Cycle 1 Day 8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg1.1819.8Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg1.5475.4Not reportedNot reportedNot reported
Cycle 1 Day 15
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg2.7623.7Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg2.8852.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.7
        value
        2.76
      2. group Id
        OG001
        spread
        52.4
        value
        2.88
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.7
        value
        1.46
      2. group Id
        OG001
        spread
        78.4
        value
        1.38
    title
    Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.8
        value
        1.18
      2. group Id
        OG001
        spread
        75.4
        value
        1.54
    title
    Cycle 1 Day 8
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.7
        value
        2.76
      2. group Id
        OG001
        spread
        52.4
        value
        2.88
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
    id
    OG000
    title
    Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
  2. description
    Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
    id
    OG001
    title
    Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
param Type
GEOMETRIC_MEAN
population Description
Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.
reporting Status
POSTED
time Frame
Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1
title
Part 1: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice