TriangleNCT02552121 · OUTCOME
Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- percentage of change
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline to end of trial (Part 2), up to 36 weeks
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.
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.
| Group | Source count |
|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 11 |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 3 |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 1 |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 5 |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 1 |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | -17.34 | 43.388 | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 32.78 | 83.933 | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | -63.27 | NA | Not reported | Not reported | Only 1 participant is included in this arm, therefore Standard deviation cannot be calculated. |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 0.74 | 21.877 | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 0 | NA | Not reported | Not reported | Only 1 participant is included in this arm, therefore Standard deviation cannot be calculated. |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 11.76 | 27.658 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 43.388
- value
- -17.34
- group Id
- OG001
- spread
- 83.933
- value
- 32.78
- comment
- Only 1 participant is included in this arm, therefore Standard deviation cannot be calculated.
- group Id
- OG002
- spread
- NA
- value
- -63.27
- group Id
- OG003
- spread
- 21.877
- value
- 0.74
- comment
- Only 1 participant is included in this arm, therefore Standard deviation cannot be calculated.
- group Id
- OG004
- spread
- NA
- value
- 0
- group Id
- OG005
- spread
- 27.658
- value
- 11.76
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- units
- Participants
- dispersion Type
- Standard Deviation
- 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.
- 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.
- id
- OG005
- title
- Part 2: Cohort Expansion: Cohort 6 1q3w Cervical
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- Baseline to end of trial (Part 2), up to 36 weeks
- title
- Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements
- type
- SECONDARY
- unit Of Measure
- percentage of change
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice