TriangleNCT02552121 · OUTCOME
Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic 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
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Before infusion of 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.
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 | 3 |
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 6 |
Reported measurements
Cycle 1 Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 30.0 | 0 | Not reported | Not reported | Not reported |
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 30.0 | 0 | Not reported | Not reported | Not reported |
Cycle 1 Day 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 797.3 | 22.1 | Not reported | Not reported | Not reported |
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 1328.5 | 191.8 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 912.1 | 23.7 | Not reported | Not reported | Not reported |
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 989.0 | 44.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 30.0
- group Id
- OG001
- spread
- 0
- value
- 30.0
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 22.1
- value
- 797.3
- group Id
- OG001
- spread
- 191.8
- value
- 1328.5
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 23.7
- value
- 912.1
- group Id
- OG001
- spread
- 44.3
- value
- 989.0
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 3
- 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
- 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.
- reporting Status
- POSTED
- time Frame
- Before infusion of Day 1, 8 and 15 of Cycle 1
- title
- Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Tisotumab Vedotin (HuMax-TF-ADC)
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice