TriangleNCT02001623 · OUTCOME
Dose Escalation and Expansion Part: AUC0-t of Free Monomethyl Auristatin E (MMAE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- day*ng/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 in each part of the study.
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.
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study
| 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 |
| Dose Expansion Part: Pharmacokinetics (PK) Analysis Set | 168 |
Reported measurements
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 |
| Dose Expansion Part: Pharmacokinetics (PK) Analysis Set | 168 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 6.20 | 72.05 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 12.61 | 28.18 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 12.22 | 67.23 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 11.63 | 52.69 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 26.55 | 44.24 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 22.55 | 57.26 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 67.42 | 59.98 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 26.47 | 59.35 | Not reported | Not reported | Not reported |
| Dose Expansion Part: Pharmacokinetics (PK) Analysis Set | 25.80 | 93.91 | Not reported | Not reported | Not reported |
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 | 3 |
| Dose Escalation Part: 2.0 mg/kg | 2 |
| Dose Escalation Part: 2.2 mg/kg | 3 |
| Dose Expansion Part: Pharmacokinetics (PK) Analysis Set | 145 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 3.19 | 140.85 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 4.69 | 87.27 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.9 mg/kg | 14.89 | 66.97 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 16.92 | 58.12 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.5 mg/kg | 21.51 | 34.25 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 18.97 | 52.14 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.0 mg/kg | 36.20 | 33.82 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 2.2 mg/kg | 37.50 | 43.08 | Not reported | Not reported | Not reported |
| Dose Expansion Part: Pharmacokinetics (PK) Analysis Set | 23.48 | 76.47 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 72.05
- value
- 6.20
- group Id
- OG001
- spread
- 28.18
- value
- 12.61
- group Id
- OG002
- spread
- 67.23
- value
- 12.22
- group Id
- OG003
- spread
- 52.69
- value
- 11.63
- group Id
- OG004
- spread
- 44.24
- value
- 26.55
- group Id
- OG005
- spread
- 57.26
- value
- 22.55
- group Id
- OG006
- spread
- 59.98
- value
- 67.42
- group Id
- OG007
- spread
- 59.35
- value
- 26.47
- group Id
- OG008
- spread
- 93.91
- value
- 25.80
- 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
- group Id
- OG008
- value
- 168
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 140.85
- value
- 3.19
- group Id
- OG001
- spread
- 87.27
- value
- 4.69
- group Id
- OG002
- spread
- 66.97
- value
- 14.89
- group Id
- OG003
- spread
- 58.12
- value
- 16.92
- group Id
- OG004
- spread
- 34.25
- value
- 21.51
- group Id
- OG005
- spread
- 52.14
- value
- 18.97
- group Id
- OG006
- spread
- 33.82
- value
- 36.20
- group Id
- OG007
- spread
- 43.08
- value
- 37.50
- group Id
- OG008
- spread
- 76.47
- value
- 23.48
- 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
- 2
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 145
- units
- Participants
- title
- 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
- group Id
- OG008
- value
- 168
- 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.
- 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
- description
- PK was only planned to be analyzed per the dose level received, not per cancer type. So the PK data is pooled for all participants in the dose expansion part of the study
- id
- OG008
- title
- Dose Expansion Part: Pharmacokinetics (PK) Analysis Set
- 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 and Expansion Part: AUC0-t of Free Monomethyl Auristatin E (MMAE)
- type
- SECONDARY
- unit Of Measure
- day*ng/mL
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Preserved source evidence · Not medical advice