TriangleNCT02001623 · OUTCOME
Dose Escalation Part: Half-life (t1/2) 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
- hours
- 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. t1/2 was only analyzed for the dose escalation part of the study. Data was not planned to be collected for t1/2 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 | 3 |
| 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 | 3 |
| 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: 0.3 mg/kg | 12.22 | 11.61 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 29.53 | 4.08 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 33.72 | 6.26 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 41.06 | 6.85 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 32.42 | 20.05 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 47.89 | 25.82 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 40.93 | 11.48 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 41.19 | 34.02 | Not reported | Not reported | Not reported |
Tisotumab Vedotin: Cycle 2
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3 |
| 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: 0.3 mg/kg | 13.54 | 5.50 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 23.50 | 39.89 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 33.68 | 1.74 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 40.44 | 4.69 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 33.62 | 14.50 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 32.15 | 62.74 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 39.89 | 23.15 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 48.93 | 5.61 | Not reported | Not reported | Not reported |
Total HuMax-TF: Cycle 1
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3 |
| 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 | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 16.05 | 27.93 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 28.66 | 30.64 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 42.52 | 7.48 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 57.37 | 8.65 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 42.72 | 34.62 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 57.72 | 17.47 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 54.95 | 5.32 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 55.10 | 27.36 | Not reported | Not reported | Not reported |
Total HuMax-TF: Cycle 2
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3 |
| 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: 0.3 mg/kg | 18.34 | 8.73 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 30.71 | 27.65 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 40.37 | 4.27 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 56.77 | 9.60 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 42.18 | 25.39 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 46.24 | 53.11 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 51.06 | 9.18 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 66.05 | 10.07 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.61
- value
- 12.22
- group Id
- OG001
- spread
- 4.08
- value
- 29.53
- group Id
- OG002
- spread
- 6.26
- value
- 33.72
- group Id
- OG003
- spread
- 6.85
- value
- 41.06
- group Id
- OG004
- spread
- 20.05
- value
- 32.42
- group Id
- OG005
- spread
- 25.82
- value
- 47.89
- group Id
- OG006
- spread
- 11.48
- value
- 40.93
- group Id
- OG007
- spread
- 34.02
- value
- 41.19
- denoms
- counts
- group Id
- OG000
- value
- 3
- 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
- OG000
- spread
- 5.50
- value
- 13.54
- group Id
- OG001
- spread
- 39.89
- value
- 23.50
- group Id
- OG002
- spread
- 1.74
- value
- 33.68
- group Id
- OG003
- spread
- 4.69
- value
- 40.44
- group Id
- OG004
- spread
- 14.50
- value
- 33.62
- group Id
- OG005
- spread
- 62.74
- value
- 32.15
- group Id
- OG006
- spread
- 23.15
- value
- 39.89
- group Id
- OG007
- spread
- 5.61
- value
- 48.93
- denoms
- counts
- group Id
- OG000
- value
- 3
- 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
- OG000
- spread
- 27.93
- value
- 16.05
- group Id
- OG001
- spread
- 30.64
- value
- 28.66
- group Id
- OG002
- spread
- 7.48
- value
- 42.52
- group Id
- OG003
- spread
- 8.65
- value
- 57.37
- group Id
- OG004
- spread
- 34.62
- value
- 42.72
- group Id
- OG005
- spread
- 17.47
- value
- 57.72
- group Id
- OG006
- spread
- 5.32
- value
- 54.95
- group Id
- OG007
- spread
- 27.36
- value
- 55.10
- denoms
- counts
- group Id
- OG000
- value
- 3
- 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
- 6
- units
- Participants
- title
- Total HuMax-TF: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 8.73
- value
- 18.34
- group Id
- OG001
- spread
- 27.65
- value
- 30.71
- group Id
- OG002
- spread
- 4.27
- value
- 40.37
- group Id
- OG003
- spread
- 9.60
- value
- 56.77
- group Id
- OG004
- spread
- 25.39
- value
- 42.18
- group Id
- OG005
- spread
- 53.11
- value
- 46.24
- group Id
- OG006
- spread
- 9.18
- value
- 51.06
- group Id
- OG007
- spread
- 10.07
- value
- 66.05
- denoms
- counts
- group Id
- OG000
- value
- 3
- 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
- 3
- 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. t1/2 was only analyzed for the dose escalation part of the study. Data was not planned to be collected for t1/2 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: Half-life (t1/2) of Tisotumab Vedotin and Total HuMax-TF
- type
- SECONDARY
- unit Of Measure
- hours
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Preserved source evidence · Not medical advice