TriangleNCT02001623 · OUTCOME
Dose Escalation Part: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) 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
- day*ug/mL
- 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. AUC0-inf was only analyzed in the dose escalation part of the study. Data was not planned to be collected for the AUC0-inf 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 | 6 |
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 | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.6 mg/kg | 15.57 | 7.81 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 25.77 | 15.70 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 46.68 | 10.99 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 33.95 | 20.93 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 63.88 | 48.61 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 53.47 | 30.88 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 105.84 | 8.68 | 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 | 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 | 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 | 14.52 | 4.98 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 26.12 | 6.44 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 46.59 | 9.98 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 30.56 | 26.43 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 80.59 | 24.03 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 64.10 | 19.06 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 88.95 | 11.04 | 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 | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.6 mg/kg | 23.75 | 0.20 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 37.02 | 16.39 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 69.96 | 13.26 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 48.19 | 35.67 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 90.08 | 52.74 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 93.29 | 30.45 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 157.81 | 12.70 | 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 | 23.01 | 9.95 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 37.08 | 6.37 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 67.93 | 14.25 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 43.41 | 30.31 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 136.08 | 12.41 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 98.59 | 26.45 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 145.82 | 9.42 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 7.81
- value
- 15.57
- group Id
- OG002
- spread
- 15.70
- value
- 25.77
- group Id
- OG003
- spread
- 10.99
- value
- 46.68
- group Id
- OG004
- spread
- 20.93
- value
- 33.95
- group Id
- OG005
- spread
- 48.61
- value
- 63.88
- group Id
- OG006
- spread
- 30.88
- value
- 53.47
- group Id
- OG007
- spread
- 8.68
- value
- 105.84
- 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
- 6
- units
- Participants
- title
- Tisotumab Vedotin: Cycle 1
- categories
- measurements
- group Id
- OG001
- spread
- 4.98
- value
- 14.52
- group Id
- OG002
- spread
- 6.44
- value
- 26.12
- group Id
- OG003
- spread
- 9.98
- value
- 46.59
- group Id
- OG004
- spread
- 26.43
- value
- 30.56
- group Id
- OG005
- spread
- 24.03
- value
- 80.59
- group Id
- OG006
- spread
- 19.06
- value
- 64.10
- group Id
- OG007
- spread
- 11.04
- value
- 88.95
- 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
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- units
- Participants
- title
- Tisotumab Vedotin: Cycle 2
- categories
- measurements
- group Id
- OG001
- spread
- 0.20
- value
- 23.75
- group Id
- OG002
- spread
- 16.39
- value
- 37.02
- group Id
- OG003
- spread
- 13.26
- value
- 69.96
- group Id
- OG004
- spread
- 35.67
- value
- 48.19
- group Id
- OG005
- spread
- 52.74
- value
- 90.08
- group Id
- OG006
- spread
- 30.45
- value
- 93.29
- group Id
- OG007
- spread
- 12.70
- value
- 157.81
- 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
- 2
- units
- Participants
- title
- Total HuMax-TF: Cycle 1
- categories
- measurements
- group Id
- OG001
- spread
- 9.95
- value
- 23.01
- group Id
- OG002
- spread
- 6.37
- value
- 37.08
- group Id
- OG003
- spread
- 14.25
- value
- 67.93
- group Id
- OG004
- spread
- 30.31
- value
- 43.41
- group Id
- OG005
- spread
- 12.41
- value
- 136.08
- group Id
- OG006
- spread
- 26.45
- value
- 98.59
- group Id
- OG007
- spread
- 9.42
- value
- 145.82
- 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
- 6
- units
- Participants
- description
- PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2. AUC0-inf was only analyzed in the dose escalation part of the study. Data was not planned to be collected for the AUC0-inf 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: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tisotumab Vedotin and Total HuMax-TF
- type
- SECONDARY
- unit Of Measure
- day*ug/mL
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Preserved source evidence · Not medical advice