TriangleNCT03215030 · OUTCOME
Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hour*nanogram per milliliter (h*ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
What was measured
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
Analysis population: PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.Given low exposure at 0.01mg/kg dose,there was insufficient data to characterize terminal phase PK required for calculating this parameter.Consequently,this parameter has been marked as "Not Calculated" and therefore not reported for Part 1,Schedule A,0.01mg/kg dose group,in accordance with non-compartmental PK analysis standards.
Groups in this outcome
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg
Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) 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 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 1 (Dose Escalation) 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.
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 3 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 14900 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 209000 | 83.4 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 20500 | 33.2 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 14100 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 288000 | 44.5 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 199000 | 104.4 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 240000 | 109.7 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 3 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 2410 | 21.3 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 24000 | 38.0 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 286000 | 66.5 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 24300 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 20100 | 21.7 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 0 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 1 |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 2 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 4 |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 28000 | 49.3 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 73600 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg | 333000 | 54.0 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 243000 | 54.5 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 215000 | NA | Not reported | Not reported | Geometric coefficient of variation was not estimable for a single participant. |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG002
- spread
- NA
- value
- 14900
- group Id
- OG003
- spread
- 83.4
- value
- 209000
- group Id
- OG005
- spread
- 33.2
- value
- 20500
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG006
- spread
- NA
- value
- 14100
- group Id
- OG007
- spread
- 44.5
- value
- 288000
- group Id
- OG008
- spread
- 104.4
- value
- 199000
- group Id
- OG009
- spread
- 109.7
- value
- 240000
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG001
- spread
- 21.3
- value
- 2410
- group Id
- OG002
- spread
- 38.0
- value
- 24000
- group Id
- OG003
- spread
- 66.5
- value
- 286000
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG004
- spread
- NA
- value
- 24300
- group Id
- OG005
- spread
- 21.7
- value
- 20100
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- group Id
- OG002
- spread
- 49.3
- value
- 28000
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG006
- spread
- NA
- value
- 73600
- group Id
- OG007
- spread
- 54.0
- value
- 333000
- group Id
- OG008
- spread
- 54.5
- value
- 243000
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG009
- spread
- NA
- value
- 215000
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 1
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- units
- Participants
- description
- As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg
- description
- Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
- description
- Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
- description
- Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
- description
- Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG004
- title
- Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
- description
- Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG005
- title
- Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
- 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
- OG006
- title
- Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
- description
- Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG007
- title
- Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
- description
- Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG008
- title
- Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
- 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
- OG009
- title
- Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Analysis Set; Overall number analyzed: participants with data available for analysis.Number analyzed: participants with data available during specified time-point.Given low exposure at 0.01mg/kg dose,there was insufficient data to characterize terminal phase PK required for calculating this parameter.Consequently,this parameter has been marked as "Not Calculated" and therefore not reported for Part 1,Schedule A,0.01mg/kg dose group,in accordance with non-compartmental PK analysis standards.
- reporting Status
- POSTED
- time Frame
- Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
- title
- Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
- type
- SECONDARY
- unit Of Measure
- hour*nanogram per milliliter (h*ng/mL)
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Preserved source evidence · Not medical advice