TriangleNCT02460224 · OUTCOME
Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ug/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
What was measured
Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
Analysis population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Groups in this outcome
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 3 mg/kg Q2W | 0 |
| Phase 1: LAG525 5 mg/kg Q2W | 0 |
| Phase 1: LAG525 10 mg/kg Q2W | 0 |
| Phase 1: LAG525 15 mg/kg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W | 0 |
| Phase 1: LAG525 400 mg Q2W | 0 |
| Phase 1: LAG525 3 mg/kg Q4W | 0 |
| Phase 1: LAG525 5 mg/kg Q4W | 0 |
| Phase 1: LAG525 10 mg/kg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W | 0 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 5 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 11 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 4 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 10 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
Reported measurements
Cycle 1, ROW patients
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 3 mg/kg Q2W | 0 |
| Phase 1: LAG525 5 mg/kg Q2W | 0 |
| Phase 1: LAG525 10 mg/kg Q2W | 0 |
| Phase 1: LAG525 15 mg/kg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W | 0 |
| Phase 1: LAG525 400 mg Q2W | 0 |
| Phase 1: LAG525 3 mg/kg Q4W | 0 |
| Phase 1: LAG525 5 mg/kg Q4W | 0 |
| Phase 1: LAG525 10 mg/kg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W | 0 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 5 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 14 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 4 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 11 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 4 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 8 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 9 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 5 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 19.6 | 3.59 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 19.6 | 2.77 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 17.7 | 3.84 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 58.8 | 23.2 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 67.9 | 20.4 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 76.2 | 20 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 61.5 | 22.1 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 85.1 | 28 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 65 | 11.3 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 87.6 | 24.5 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 113 | 26.8 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 116 | 28.1 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 100 | 23.1 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 115 | 33.2 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 97.9 | 17 | Not reported | Not reported | Not reported |
Cycle 3, ROW patients
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 3 mg/kg Q2W | 0 |
| Phase 1: LAG525 5 mg/kg Q2W | 0 |
| Phase 1: LAG525 10 mg/kg Q2W | 0 |
| Phase 1: LAG525 15 mg/kg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W | 0 |
| Phase 1: LAG525 400 mg Q2W | 0 |
| Phase 1: LAG525 3 mg/kg Q4W | 0 |
| Phase 1: LAG525 5 mg/kg Q4W | 0 |
| Phase 1: LAG525 10 mg/kg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W | 0 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 3 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 4 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 2 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 3 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 3 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 8 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 3 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 7 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 2 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 1 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 3 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 2 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 5 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 30.4 | 11.9 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 28.7 | 8.4 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 29.7 | 9.97 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 89.5 | 28.9 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 168 | 20.1 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 97.5 | 34.4 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 80 | 25.1 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 123 | 35.6 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 90.8 | 51.2 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 142 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 134 | 56.7 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 167 | 9.9 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 141 | 58.2 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 147 | 29.8 | Not reported | Not reported | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 126 | 27.2 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG011
- spread
- 3.59
- value
- 19.6
- group Id
- OG012
- spread
- 2.77
- value
- 19.6
- group Id
- OG013
- spread
- 3.84
- value
- 17.7
- group Id
- OG014
- spread
- 23.2
- value
- 58.8
- group Id
- OG015
- spread
- 20.4
- value
- 67.9
- group Id
- OG016
- spread
- 20
- value
- 76.2
- group Id
- OG017
- spread
- 22.1
- value
- 61.5
- group Id
- OG018
- spread
- 28
- value
- 85.1
- group Id
- OG019
- spread
- 11.3
- value
- 65
- group Id
- OG020
- spread
- 24.5
- value
- 87.6
- group Id
- OG021
- spread
- 26.8
- value
- 113
- group Id
- OG022
- spread
- 28.1
- value
- 116
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 5
- units
- Participants
- title
- Cycle 1, ROW patients
- categories
- measurements
- group Id
- OG011
- spread
- 11.9
- value
- 30.4
- group Id
- OG012
- spread
- 8.4
- value
- 28.7
- group Id
- OG013
- spread
- 9.97
- value
- 29.7
- group Id
- OG014
- spread
- 28.9
- value
- 89.5
- group Id
- OG015
- spread
- 20.1
- value
- 168
- group Id
- OG016
- spread
- 34.4
- value
- 97.5
- group Id
- OG017
- spread
- 25.1
- value
- 80
- group Id
- OG018
- spread
- 35.6
- value
- 123
- group Id
- OG019
- spread
- 51.2
- value
- 90.8
- group Id
- OG020
- value
- 142
- group Id
- OG021
- spread
- 56.7
- value
- 134
- group Id
- OG022
- spread
- 9.9
- value
- 167
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 3
- units
- Participants
- title
- Cycle 3, ROW patients
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.
- dispersion Type
- Standard Deviation
- groups
- description
- Single-agent LAG525 1 mg/kg Q2W
- id
- OG000
- title
- Phase 1: LAG525 1 mg/kg Q2W
- description
- Single-agent LAG525 3 mg/kg Q2W
- id
- OG001
- title
- Phase 1: LAG525 3 mg/kg Q2W
- description
- Single-agent LAG525 5 mg/kg Q2W
- id
- OG002
- title
- Phase 1: LAG525 5 mg/kg Q2W
- description
- Single-agent LAG525 10 mg/kg Q2W
- id
- OG003
- title
- Phase 1: LAG525 10 mg/kg Q2W
- description
- Single-agent LAG525 15 mg/kg Q2W
- id
- OG004
- title
- Phase 1: LAG525 15 mg/kg Q2W
- description
- Single-agent LAG525 240 mg Q2W
- id
- OG005
- title
- Phase 1: LAG525 240 mg Q2W
- description
- Single-agent LAG525 400 mg Q2W
- id
- OG006
- title
- Phase 1: LAG525 400 mg Q2W
- description
- Single-agent LAG525 3 mg/kg Q4W
- id
- OG007
- title
- Phase 1: LAG525 3 mg/kg Q4W
- description
- Single-agent LAG525 5 mg/kg Q4W
- id
- OG008
- title
- Phase 1: LAG525 5 mg/kg Q4W
- description
- Single-agent LAG525 10 mg/kg Q4W
- id
- OG009
- title
- Phase 1: LAG525 10 mg/kg Q4W
- description
- Single-agent LAG525 400 mg Q4W
- id
- OG010
- title
- Phase 1: LAG525 400 mg Q4W
- description
- Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
- id
- OG011
- title
- Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
- param Type
- MEAN
- population Description
- All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
- reporting Status
- POSTED
- time Frame
- pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
- title
- Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice