TriangleNCT05551117 · OUTCOME
Part 1: Median Duration of Response (DoR) Per PCWG3 Criteria as Determined by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.
What was measured
The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
Analysis population: All participants with mCRPC who achieved a confirmed complete or partial response to study treatment. No participants in the control group had a complete or partial response. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
Groups in this outcome
Part 1: MGC018 2.0 mg (Arm A)
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
| Group | Source count |
|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 8 |
| Part 1: MGC018 2.7 mg (Arm B) | 15 |
| Part 1: Control Arm | 0 |
| Part 2 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 9.4 | Not reported | 3.68 | NA | The upper bound of the CI could not be estimated due to insufficient number of participants with events |
| Part 1: MGC018 2.7 mg (Arm B) | 9.1 | Not reported | 5.78 | 9.92 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper bound of the CI could not be estimated due to insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 3.68
- upper Limit
- NA
- value
- 9.4
- group Id
- OG001
- lower Limit
- 5.78
- upper Limit
- 9.92
- value
- 9.1
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
- id
- OG000
- title
- Part 1: MGC018 2.0 mg (Arm A)
- description
- vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
- id
- OG001
- title
- Part 1: MGC018 2.7 mg (Arm B)
- description
- abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
- id
- OG002
- title
- Part 1: Control Arm
- description
- vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
- id
- OG003
- title
- Part 2
- param Type
- MEDIAN
- population Description
- All participants with mCRPC who achieved a confirmed complete or partial response to study treatment. No participants in the control group had a complete or partial response. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.
- title
- Part 1: Median Duration of Response (DoR) Per PCWG3 Criteria as Determined by the Investigator
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice