TriangleNCT02552121 · OUTCOME
Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- 0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1
What was measured
CL could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.
Analysis population: CL could not be estimated for Part 1 or Part 2 participants.
Groups in this outcome
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
| Group | Source count |
|---|---|
| Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg | 0 |
| Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg | 0 |
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 0 |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 0 |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 0 |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 0 |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 0 |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- units
- Participants
- description
- CL could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.
- groups
- description
- Tisotumab vedotin 0.9 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- id
- OG000
- title
- Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
- description
- Tisotumab vedotin 1.2 mg/kg was administered as an intravenous infusion, over a minimum of 30 minutes, 3 times every 4 weeks (3q4wk).
- id
- OG001
- title
- Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- id
- OG002
- title
- Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (the recommended dose for phase II trials \[RP2D\] from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk).
- id
- OG003
- title
- Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
- id
- OG004
- title
- Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
- description
- Participants with the indication of cervical cancer, received Tisotumab vedotin 1.2 mg/kg (RP2D from the Dose Escalation part), administered as an intravenous infusion, over a minimum of 30 minutes 3 times every 4 weeks (3q4wk). Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg, administered as an intravenous infusion once every 3 weeks (1q3w).
- id
- OG005
- title
- Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
- description
- Participants with the indication of ovarian cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
- id
- OG006
- title
- Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian
- description
- Participants with the indication of cervical cancer, received Tisotumab vedotin 2.0 mg/kg, administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3w); the revised dose and schedule due to severe ocular toxicity observed at 1.2 mg/kg 3q4wk.
- id
- OG007
- title
- Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
- population Description
- CL could not be estimated for Part 1 or Part 2 participants.
- reporting Status
- POSTED
- time Frame
- 0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1
- title
- Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)
- type
- SECONDARY
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Preserved source evidence · Not medical advice