TriangleNCT02001623 · OUTCOME
Dose Escalation Part: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mL/kg
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)
What was measured
PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study. Data was not planned to be collected for the volume of distribution of tisotumab vedotin and total HuMax-TF for the dose expansion part.
Analysis population: PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
Groups in this outcome
Dose Escalation Part: 0.3 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
Dose Escalation Part: 0.6 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
Dose Escalation Part: 0.9 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
Dose Escalation Part: 1.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
Dose Escalation Part: 1.5 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
Dose Escalation Part: 1.8 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
Dose Escalation Part: 2.0 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
Dose Escalation Part: 2.2 mg/kg
Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 |
| Dose Escalation Part: 0.6 mg/kg | 3 |
| Dose Escalation Part: 0.9 mg/kg | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 3 |
| Dose Escalation Part: 2.0 mg/kg | 3 |
| Dose Escalation Part: 2.2 mg/kg | 5 |
Reported measurements
Tisotumab Vedotin: Cycle 1
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 |
| Dose Escalation Part: 0.6 mg/kg | 3 |
| Dose Escalation Part: 0.9 mg/kg | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 3 |
| Dose Escalation Part: 2.0 mg/kg | 3 |
| Dose Escalation Part: 2.2 mg/kg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.6 mg/kg | 68.40 | 11.84 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 70.80 | 14.54 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 63.46 | 16.87 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 86.10 | 12.38 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 81.13 | 35.60 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 92.04 | 21.62 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 61.46 | 18.07 | Not reported | Not reported | Not reported |
Tisotumab Vedotin: Cycle 2
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 |
| Dose Escalation Part: 0.6 mg/kg | 2 |
| Dose Escalation Part: 0.9 mg/kg | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 2 |
| Dose Escalation Part: 2.0 mg/kg | 2 |
| Dose Escalation Part: 2.2 mg/kg | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.6 mg/kg | 76.69 | 9.53 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 69.74 | 7.99 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 62.61 | 6.03 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 99.20 | 20.82 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 70.21 | 42.93 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 74.82 | 4.19 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 72.74 | 5.79 | Not reported | Not reported | Not reported |
Total HuMax-TF: Cycle 1
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 |
| Dose Escalation Part: 0.6 mg/kg | 2 |
| Dose Escalation Part: 0.9 mg/kg | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 3 |
| Dose Escalation Part: 2.0 mg/kg | 3 |
| Dose Escalation Part: 2.2 mg/kg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.6 mg/kg | 51.55 | 1.61 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 60.27 | 17.79 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 57.38 | 8.65 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 77.55 | 10.74 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 67.26 | 50.61 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 68.69 | 30.52 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 50.69 | 7.20 | Not reported | Not reported | Not reported |
Total HuMax-TF: Cycle 2
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 |
| Dose Escalation Part: 0.6 mg/kg | 2 |
| Dose Escalation Part: 0.9 mg/kg | 3 |
| Dose Escalation Part: 1.2 mg/kg | 3 |
| Dose Escalation Part: 1.5 mg/kg | 3 |
| Dose Escalation Part: 1.8 mg/kg | 2 |
| Dose Escalation Part: 2.0 mg/kg | 2 |
| Dose Escalation Part: 2.2 mg/kg | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.6 mg/kg | 55.75 | 10.80 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 57.13 | 8.90 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 58.48 | 12.66 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 84.98 | 22.85 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 50.62 | 36.02 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 60.40 | 17.48 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 58.10 | 12.31 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 11.84
- value
- 68.40
- group Id
- OG002
- spread
- 14.54
- value
- 70.80
- group Id
- OG003
- spread
- 16.87
- value
- 63.46
- group Id
- OG004
- spread
- 12.38
- value
- 86.10
- group Id
- OG005
- spread
- 35.60
- value
- 81.13
- group Id
- OG006
- spread
- 21.62
- value
- 92.04
- group Id
- OG007
- spread
- 18.07
- value
- 61.46
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- units
- Participants
- title
- Tisotumab Vedotin: Cycle 1
- categories
- measurements
- group Id
- OG001
- spread
- 9.53
- value
- 76.69
- group Id
- OG002
- spread
- 7.99
- value
- 69.74
- group Id
- OG003
- spread
- 6.03
- value
- 62.61
- group Id
- OG004
- spread
- 20.82
- value
- 99.20
- group Id
- OG005
- spread
- 42.93
- value
- 70.21
- group Id
- OG006
- spread
- 4.19
- value
- 74.82
- group Id
- OG007
- spread
- 5.79
- value
- 72.74
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- Tisotumab Vedotin: Cycle 2
- categories
- measurements
- group Id
- OG001
- spread
- 1.61
- value
- 51.55
- group Id
- OG002
- spread
- 17.79
- value
- 60.27
- group Id
- OG003
- spread
- 8.65
- value
- 57.38
- group Id
- OG004
- spread
- 10.74
- value
- 77.55
- group Id
- OG005
- spread
- 50.61
- value
- 67.26
- group Id
- OG006
- spread
- 30.52
- value
- 68.69
- group Id
- OG007
- spread
- 7.20
- value
- 50.69
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- units
- Participants
- title
- Total HuMax-TF: Cycle 1
- categories
- measurements
- group Id
- OG001
- spread
- 10.80
- value
- 55.75
- group Id
- OG002
- spread
- 8.90
- value
- 57.13
- group Id
- OG003
- spread
- 12.66
- value
- 58.48
- group Id
- OG004
- spread
- 22.85
- value
- 84.98
- group Id
- OG005
- spread
- 36.02
- value
- 50.62
- group Id
- OG006
- spread
- 17.48
- value
- 60.40
- group Id
- OG007
- spread
- 12.31
- value
- 58.10
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- Total HuMax-TF: Cycle 2
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- units
- Participants
- description
- PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study. Data was not planned to be collected for the volume of distribution of tisotumab vedotin and total HuMax-TF for the dose expansion part.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an intravenous (IV) infusion at a dose of 0.3 mg/kg of body weight.
- id
- OG000
- title
- Dose Escalation Part: 0.3 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.6 mg/kg of body weight.
- id
- OG001
- title
- Dose Escalation Part: 0.6 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 0.9 mg/kg of body weight.
- id
- OG002
- title
- Dose Escalation Part: 0.9 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.2 mg/kg of body weight.
- id
- OG003
- title
- Dose Escalation Part: 1.2 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.5 mg/kg of body weight.
- id
- OG004
- title
- Dose Escalation Part: 1.5 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 1.8 mg/kg of body weight.
- id
- OG005
- title
- Dose Escalation Part: 1.8 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.0 mg/kg of body weight.
- id
- OG006
- title
- Dose Escalation Part: 2.0 mg/kg
- description
- Participants received tisotumab vedotin on Day 1 of each cycle (each treatment cycle was 21 days) as an IV infusion at a dose of 2.2 mg/kg of body weight.
- id
- OG007
- title
- Dose Escalation Part: 2.2 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis set: all participants who had been exposed to tisotumab vedotin and had at least 1 PK assessment after first dose.
- reporting Status
- POSTED
- time Frame
- Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)
- title
- Dose Escalation Part: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF
- type
- SECONDARY
- unit Of Measure
- mL/kg
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Preserved source evidence · Not medical advice