TriangleNCT02923349 · OUTCOME
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/ml
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
What was measured
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Analysis population: The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
Groups in this outcome
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
| Group | Source count |
|---|---|
| PART 1 Dose 1 (7 mg) | 4 |
| PART 1 Dose 2 (20 mg) | 4 |
| PART 1 Dose 3 (70 mg) | 21 |
| PART 1 Dose 4 (200 mg) | 17 |
| PART 1 Dose 5 (350 mg) | 21 |
| PART 1 Dose 6 (700 mg) | 7 |
| PART 1 Dose 7 (1400 mg) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 1630 | 735 | Not reported | Not reported | Not reported |
| PART 1 Dose 2 (20 mg) | 5820 | 324 | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 22300 | 32800 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 39200 | 10300 | Not reported | Not reported | Not reported |
| PART 1 Dose 5 (350 mg) | 84900 | 76700 | Not reported | Not reported | Not reported |
| PART 1 Dose 6 (700 mg) | 207000 | 45500 | Not reported | Not reported | Not reported |
| PART 1 Dose 7 (1400 mg) | 347000 | 130000 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 735
- value
- 1630
- group Id
- OG001
- spread
- 324
- value
- 5820
- group Id
- OG002
- spread
- 32800
- value
- 22300
- group Id
- OG003
- spread
- 10300
- value
- 39200
- group Id
- OG004
- spread
- 76700
- value
- 84900
- group Id
- OG005
- spread
- 45500
- value
- 207000
- group Id
- OG006
- spread
- 130000
- value
- 347000
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 17
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 4
- units
- Participants
- description
- To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
- dispersion Type
- Standard Deviation
- groups
- description
- INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG000
- title
- PART 1 Dose 1 (7 mg)
- description
- INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG001
- title
- PART 1 Dose 2 (20 mg)
- description
- INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG002
- title
- PART 1 Dose 3 (70 mg)
- description
- INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG003
- title
- PART 1 Dose 4 (200 mg)
- description
- INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG004
- title
- PART 1 Dose 5 (350 mg)
- description
- INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG005
- title
- PART 1 Dose 6 (700 mg)
- description
- INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG006
- title
- PART 1 Dose 7 (1400 mg)
- param Type
- MEAN
- population Description
- The PK evaluable population will include all subjects who received at least 1 dose of INCAGN01949 and provided at least 1 post dose sample (1 PK measurement).
- reporting Status
- POSTED
- time Frame
- Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
- title
- Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
- type
- SECONDARY
- unit Of Measure
- ng/ml
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice