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NCT02552121 · OUTCOME

Part 1: Duration of Response

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Baseline to end of trial (Part 1), up to 72 weeks

What was measured

Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) to the date of first progressive disease (PD) or death.

Analysis population: Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.

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/kg0
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) to the date of first progressive disease (PD) or death.
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
population Description
Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.
reporting Status
POSTED
time Frame
Baseline to end of trial (Part 1), up to 72 weeks
title
Part 1: Duration of Response
type
SECONDARY

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

Preserved source evidence · Not medical advice