TriangleNCT01609556 · OUTCOME
Duration of Response (DOR) as Assessed by RECIST v1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of first response (CR or PR) until the date of PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
What was measured
DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.
Analysis population: Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. 'Overall number of participants analyzed'=participants who had a BOR of CR or PR. Data by group only.
Groups in this outcome
Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
| Group | Source count |
|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) | 2 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly) | 3 |
| Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W) | 34 |
| Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) | 21.3 | Not reported | 18.4 | 24.1 | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly) | 60.2 | Not reported | 44.3 | 76.1 | Not reported |
| Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W) | 19.3 | Not reported | 18.0 | 34.0 | Not reported |
| Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W) | 28.6 | Not reported | NA | NA | Due to smaller number of events, 95% CI could not be calculated. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.4
- upper Limit
- 24.1
- value
- 21.3
- group Id
- OG001
- lower Limit
- 44.3
- upper Limit
- 76.1
- value
- 60.2
- group Id
- OG002
- lower Limit
- 18.0
- upper Limit
- 34.0
- value
- 19.3
- comment
- Due to smaller number of events, 95% CI could not be calculated.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 28.6
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 34
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG000
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
- description
- Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG001
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
- description
- Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG002
- title
- Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)
- description
- Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG003
- title
- Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
- param Type
- MEDIAN
- population Description
- Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. 'Overall number of participants analyzed'=participants who had a BOR of CR or PR. Data by group only.
- reporting Status
- POSTED
- time Frame
- From the date of first response (CR or PR) until the date of PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
- title
- Duration of Response (DOR) as Assessed by RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice