TriangleNCT02552121 · OUTCOME
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Tisotumab Vedotin (HuMax-TF-ADC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- h*µg/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), +168 hours 3rd infusion (Day 22) of Cycle 1
What was measured
Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.
Analysis population: Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for 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 | Source count |
|---|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 2 |
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 920 | 3.6 | Not reported | Not reported | Not reported |
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 1106 | 21.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.6
- value
- 920
- group Id
- OG001
- spread
- 21.3
- value
- 1106
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- 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
- 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. Includes data for all randomized participants for whom data were available.
- 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), +168 hours 3rd infusion (Day 22) of Cycle 1
- title
- Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Tisotumab Vedotin (HuMax-TF-ADC)
- type
- SECONDARY
- unit Of Measure
- h*µg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice