TriangleNCT03215030 · OUTCOME
Part 1: Vss: Volume of Distribution at Steady State 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
- liters/kg
- 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
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)\*MRT, where MRT is mean residence time. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
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 | 0.104 | 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 | 0.0352 | 23.4 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg | 0.0575 | 26.4 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 0.117 | 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 | 0.0329 | 32.1 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 0.0390 | 27.1 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 0.0536 | 24.3 | 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 | 0.150 | 24.6 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg | 0.0675 | 36.9 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg | 0.0319 | 43.3 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg | 0.0660 | 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 | 0.0624 | 14.2 | 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 | 0.0678 | 31.1 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg | 0.0640 | 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 | 0.0456 | 36.9 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg | 0.0404 | 26.8 | Not reported | Not reported | Not reported |
| Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg | 0.0716 | 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
- 0.104
- group Id
- OG003
- spread
- 23.4
- value
- 0.0352
- group Id
- OG005
- spread
- 26.4
- value
- 0.0575
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG006
- spread
- NA
- value
- 0.117
- group Id
- OG007
- spread
- 32.1
- value
- 0.0329
- group Id
- OG008
- spread
- 27.1
- value
- 0.0390
- group Id
- OG009
- spread
- 24.3
- value
- 0.0536
- 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
- 24.6
- value
- 0.150
- group Id
- OG002
- spread
- 36.9
- value
- 0.0675
- group Id
- OG003
- spread
- 43.3
- value
- 0.0319
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG004
- spread
- NA
- value
- 0.0660
- group Id
- OG005
- spread
- 14.2
- value
- 0.0624
- 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
- 31.1
- value
- 0.0678
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG006
- spread
- NA
- value
- 0.0640
- group Id
- OG007
- spread
- 36.9
- value
- 0.0456
- group Id
- OG008
- spread
- 26.8
- value
- 0.0404
- comment
- Geometric coefficient of variation was not estimable for a single participant.
- group Id
- OG009
- spread
- NA
- value
- 0.0716
- 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
- Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)\*MRT, where MRT is mean residence time. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
- 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: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
- type
- SECONDARY
- unit Of Measure
- liters/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice