TriangleNCT02923349 · OUTCOME
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ug*hr/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 AUC0-t 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
cycle 1
| 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 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 185 | 81.7 | Not reported | Not reported | Not reported |
| PART 1 Dose 2 (20 mg) | 904 | 197 | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 2370 | 841 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 5400 | 1820 | Not reported | Not reported | Not reported |
| PART 1 Dose 5 (350 mg) | 10000 | 5600 | Not reported | Not reported | Not reported |
| PART 1 Dose 6 (700 mg) | 28300 | 7720 | Not reported | Not reported | Not reported |
| PART 1 Dose 7 (1400 mg) | 61600 | 9130 | Not reported | Not reported | Not reported |
cycle 6
| Group | Source count |
|---|---|
| PART 1 Dose 1 (7 mg) | 2 |
| PART 1 Dose 2 (20 mg) | 0 |
| PART 1 Dose 3 (70 mg) | 4 |
| PART 1 Dose 4 (200 mg) | 3 |
| PART 1 Dose 5 (350 mg) | 0 |
| PART 1 Dose 6 (700 mg) | 0 |
| PART 1 Dose 7 (1400 mg) | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 427 | 9.21 | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 5490 | 1560 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 10700 | 6560 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 81.7
- value
- 185
- group Id
- OG001
- spread
- 197
- value
- 904
- group Id
- OG002
- spread
- 841
- value
- 2370
- group Id
- OG003
- spread
- 1820
- value
- 5400
- group Id
- OG004
- spread
- 5600
- value
- 10000
- group Id
- OG005
- spread
- 7720
- value
- 28300
- group Id
- OG006
- spread
- 9130
- value
- 61600
- 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
- title
- cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 9.21
- value
- 427
- group Id
- OG002
- spread
- 1560
- value
- 5490
- group Id
- OG003
- spread
- 6560
- value
- 10700
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- cycle 6
- 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 AUC0-t 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
- GEOMETRIC_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
- Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
- type
- SECONDARY
- unit Of Measure
- ug*hr/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice