TriangleNCT02552121 · OUTCOME
Part 2: Best Overall Response (OR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline to end of trial (Part 2), up to 36 weeks
What was measured
Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
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 | 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
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 2 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 1 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 5 1q3w Ovarian | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort Expansion: Cohort 6 1q3w Cervical | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 3
- 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
- title
- Not Evaluable
- 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
- description
- Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
- 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
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Baseline to end of trial (Part 2), up to 36 weeks
- title
- Part 2: Best Overall Response (OR)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice