TriangleNCT02001623 · OUTCOME
Dose Escalation Part: Clearance 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/hr/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
Pharmacokinetic (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 collected to report or calculate clearance for the expansion phase.
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 | 1.61 | 7.79 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 1.46 | 15.23 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 1.07 | 11.60 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 1.84 | 20.59 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 1.17 | 60.05 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 1.56 | 34.12 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0.87 | 8.93 | 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 | 1.72 | 4.98 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 1.44 | 6.32 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 1.07 | 10.45 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 2.05 | 26.80 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 0.93 | 24.03 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 1.30 | 19.06 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 1.03 | 11.34 | 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 | 1.02 | 0.20 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 0.98 | 16.90 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 0.69 | 12.61 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 1.26 | 31.29 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 0.81 | 69.72 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 0.87 | 33.85 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0.56 | 14.13 | 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 | 1.05 | 9.95 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 0.98 | 6.52 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 0.71 | 13.41 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 1.40 | 31.39 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 0.53 | 12.41 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 0.82 | 26.45 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 0.61 | 9.72 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 7.79
- value
- 1.61
- group Id
- OG002
- spread
- 15.23
- value
- 1.46
- group Id
- OG003
- spread
- 11.60
- value
- 1.07
- group Id
- OG004
- spread
- 20.59
- value
- 1.84
- group Id
- OG005
- spread
- 60.05
- value
- 1.17
- group Id
- OG006
- spread
- 34.12
- value
- 1.56
- group Id
- OG007
- spread
- 8.93
- value
- 0.87
- 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
- 4.98
- value
- 1.72
- group Id
- OG002
- spread
- 6.32
- value
- 1.44
- group Id
- OG003
- spread
- 10.45
- value
- 1.07
- group Id
- OG004
- spread
- 26.80
- value
- 2.05
- group Id
- OG005
- spread
- 24.03
- value
- 0.93
- group Id
- OG006
- spread
- 19.06
- value
- 1.30
- group Id
- OG007
- spread
- 11.34
- value
- 1.03
- 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
- 0.20
- value
- 1.02
- group Id
- OG002
- spread
- 16.90
- value
- 0.98
- group Id
- OG003
- spread
- 12.61
- value
- 0.69
- group Id
- OG004
- spread
- 31.29
- value
- 1.26
- group Id
- OG005
- spread
- 69.72
- value
- 0.81
- group Id
- OG006
- spread
- 33.85
- value
- 0.87
- group Id
- OG007
- spread
- 14.13
- value
- 0.56
- 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
- 9.95
- value
- 1.05
- group Id
- OG002
- spread
- 6.52
- value
- 0.98
- group Id
- OG003
- spread
- 13.41
- value
- 0.71
- group Id
- OG004
- spread
- 31.39
- value
- 1.40
- group Id
- OG005
- spread
- 12.41
- value
- 0.53
- group Id
- OG006
- spread
- 26.45
- value
- 0.82
- group Id
- OG007
- spread
- 9.72
- value
- 0.61
- 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
- Pharmacokinetic (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 collected to report or calculate clearance for the expansion phase.
- 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: Clearance of Tisotumab Vedotin and Total HuMax-TF
- type
- SECONDARY
- unit Of Measure
- mL/hr/kg
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Preserved source evidence · Not medical advice