TriangleNCT02001623 · OUTCOME
Dose Escalation Part: AUC0-inf of Free 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. AUC0-inf was not planned to be collected for the dose expansion part. AUC0-inf was not calculated where the percentage of the AUC that was due to the extrapolation was more than 20%.
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 | 2 |
| Dose Escalation Part: 0.6 mg/kg | 1 |
| Dose Escalation Part: 0.9 mg/kg | 2 |
| Dose Escalation Part: 1.2 mg/kg | 1 |
| Dose Escalation Part: 1.5 mg/kg | 2 |
| Dose Escalation Part: 1.8 mg/kg | 1 |
| Dose Escalation Part: 2.0 mg/kg | 1 |
| Dose Escalation Part: 2.2 mg/kg | 1 |
Reported measurements
Cycle 1
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 2 |
| Dose Escalation Part: 0.6 mg/kg | 1 |
| Dose Escalation Part: 0.9 mg/kg | 2 |
| Dose Escalation Part: 1.2 mg/kg | 1 |
| Dose Escalation Part: 1.5 mg/kg | 2 |
| Dose Escalation Part: 1.8 mg/kg | 1 |
| Dose Escalation Part: 2.0 mg/kg | 1 |
| Dose Escalation Part: 2.2 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.3 mg/kg | 12.63 | 12.44 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 0.6 mg/kg | 13.93 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
| Dose Escalation Part: 0.9 mg/kg | 16.32 | 57.56 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 20.39 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
| Dose Escalation Part: 1.5 mg/kg | 27.08 | 58.96 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.8 mg/kg | 25.29 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
| Dose Escalation Part: 2.0 mg/kg | 78.31 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
| Dose Escalation Part: 2.2 mg/kg | 63.03 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
Cycle 2
| Group | Source count |
|---|---|
| Dose Escalation Part: 0.3 mg/kg | 0 |
| Dose Escalation Part: 0.6 mg/kg | 0 |
| Dose Escalation Part: 0.9 mg/kg | 2 |
| Dose Escalation Part: 1.2 mg/kg | 1 |
| Dose Escalation Part: 1.5 mg/kg | 1 |
| Dose Escalation Part: 1.8 mg/kg | 1 |
| Dose Escalation Part: 2.0 mg/kg | 0 |
| Dose Escalation Part: 2.2 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation Part: 0.9 mg/kg | 22.32 | 43.62 | Not reported | Not reported | Not reported |
| Dose Escalation Part: 1.2 mg/kg | 31.40 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
| Dose Escalation Part: 1.5 mg/kg | 31.43 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
| Dose Escalation Part: 1.8 mg/kg | 33.23 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
| Dose Escalation Part: 2.2 mg/kg | 58.95 | NA | Not reported | Not reported | Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.44
- value
- 12.63
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG001
- spread
- NA
- value
- 13.93
- group Id
- OG002
- spread
- 57.56
- value
- 16.32
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG003
- spread
- NA
- value
- 20.39
- group Id
- OG004
- spread
- 58.96
- value
- 27.08
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG005
- spread
- NA
- value
- 25.29
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG006
- spread
- NA
- value
- 78.31
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG007
- spread
- NA
- value
- 63.03
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG002
- spread
- 43.62
- value
- 22.32
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG003
- spread
- NA
- value
- 31.40
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG004
- spread
- NA
- value
- 31.43
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG005
- spread
- NA
- value
- 33.23
- comment
- Only 1 participant had evaluable data, so geometric coefficient of variation could not be calculated.
- group Id
- OG007
- spread
- NA
- value
- 58.95
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- units
- Participants
- title
- Cycle 2
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- 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 not planned to be collected for the dose expansion part. AUC0-inf was not calculated where the percentage of the AUC that was due to the extrapolation was more than 20%.
- 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: AUC0-inf of Free MMAE
- type
- SECONDARY
- unit Of Measure
- day*ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice