TriangleNCT02552121 · OUTCOME
Part 2: Duration of Response
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
- Baseline to end of trial (Part 2), up to 36 weeks
What was measured
Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) to the date of first progressive disease (PD) or death.
Analysis population: Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.
Groups in this outcome
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 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
- units
- Participants
- description
- Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) to the date of first progressive disease (PD) or death.
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- title
- Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
- population Description
- Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.
- reporting Status
- POSTED
- time Frame
- Baseline to end of trial (Part 2), up to 36 weeks
- title
- Part 2: Duration of Response
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice