TriangleNCT03215030 · OUTCOME
Part 2: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Analysis population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis during the specified time-point.
Groups in this outcome
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg
Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg
Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
| Group | Source count |
|---|---|
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg | 7 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg | 3 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg | 21 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg | 6 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg | 7 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg | 3 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg | 21 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg | 5.70 | Not reported | 4.08 | 7.73 | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg | 3.27 | Not reported | 2.60 | 9.00 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg | 1.18 | Not reported | 0.93 | 3.00 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg | 1.68 | Not reported | 1.07 | 6.57 | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg | 6 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg | 3 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg | 16 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg | 5.68 | Not reported | 3.88 | 6.68 | Not reported |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg | 3.30 | Not reported | 1.12 | 9.00 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg | 1.29 | Not reported | 0.90 | 4.88 | Not reported |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg | 1.63 | Not reported | 1.10 | 3.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.08
- upper Limit
- 7.73
- value
- 5.70
- group Id
- OG001
- lower Limit
- 2.60
- upper Limit
- 9.00
- value
- 3.27
- group Id
- OG002
- lower Limit
- 0.93
- upper Limit
- 3.00
- value
- 1.18
- group Id
- OG003
- lower Limit
- 1.07
- upper Limit
- 6.57
- value
- 1.68
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.88
- upper Limit
- 6.68
- value
- 5.68
- group Id
- OG001
- lower Limit
- 1.12
- upper Limit
- 9.00
- value
- 3.30
- group Id
- OG002
- lower Limit
- 0.90
- upper Limit
- 4.88
- value
- 1.29
- group Id
- OG003
- lower Limit
- 1.10
- upper Limit
- 3.00
- value
- 1.63
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 4
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 6
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Participants received modakafusp alfa 0.4 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
- description
- Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg
- description
- Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
- description
- Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg
- param Type
- MEDIAN
- population Description
- The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis during the specified time-point.
- reporting Status
- POSTED
- time Frame
- Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
- title
- Part 2: Tmax: Time to Reach the Cmax for Modakafusp Alfa
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice