Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02552121 · OUTCOME

Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated)

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 on Day 1, 8 and 15 of Cycle 1

What was measured

Data is only available for Part 1, for Part 2, inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.

Analysis population: Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Data includes all randomized participants for whom data were available.

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 Day 1

Analysis denominator · Participants

GroupSource count
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg2
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg6
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg150.00.0Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg150.00.0Not reportedNot reportedNot reported
Cycle 1 Day 8

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
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg1273.123.4Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg1252.253.3Not reportedNot reportedNot reported
Cycle 1 Day 15

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
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg1625.124.4Not reportedNot reportedNot reported
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg1863.846.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        150.0
      2. group Id
        OG001
        spread
        0.0
        value
        150.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.4
        value
        1273.1
      2. group Id
        OG001
        spread
        53.3
        value
        1252.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Cycle 1 Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.4
        value
        1625.1
      2. group Id
        OG001
        spread
        46.6
        value
        1863.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Data is only available for Part 1, for Part 2, inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.
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. Data includes all randomized participants for whom data were available.
reporting Status
POSTED
time Frame
Before infusion on Day 1, 8 and 15 of Cycle 1
title
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice