TriangleNCT02923349 · OUTCOME
Summary of Trough Concentrations(Cmin) of INCAGN01949
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 Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
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) | 22 |
| PART 1 Dose 4 (200 mg) | 18 |
| PART 1 Dose 5 (350 mg) | 23 |
| PART 1 Dose 6 (700 mg) | 12 |
| PART 1 Dose 7 (1400 mg) | 4 |
Reported measurements
cycle 2
| Group | Source count |
|---|---|
| PART 1 Dose 1 (7 mg) | 4 |
| PART 1 Dose 2 (20 mg) | 4 |
| PART 1 Dose 3 (70 mg) | 20 |
| PART 1 Dose 4 (200 mg) | 17 |
| PART 1 Dose 5 (350 mg) | 18 |
| PART 1 Dose 6 (700 mg) | 7 |
| PART 1 Dose 7 (1400 mg) | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 303 | 202 | Not reported | Not reported | Not reported |
| PART 1 Dose 2 (20 mg) | 1890 | 1570 | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 3620 | 1550 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 8880 | 4510 | Not reported | Not reported | Not reported |
| PART 1 Dose 5 (350 mg) | 17000 | 8040 | Not reported | Not reported | Not reported |
| PART 1 Dose 6 (700 mg) | 41000 | 13000 | Not reported | Not reported | Not reported |
| PART 1 Dose 7 (1400 mg) | 117000 | 19300 | Not reported | Not reported | Not reported |
cycle 3
| Group | Source count |
|---|---|
| PART 1 Dose 1 (7 mg) | 3 |
| PART 1 Dose 2 (20 mg) | 3 |
| PART 1 Dose 3 (70 mg) | 17 |
| PART 1 Dose 4 (200 mg) | 14 |
| PART 1 Dose 5 (350 mg) | 15 |
| PART 1 Dose 6 (700 mg) | 4 |
| PART 1 Dose 7 (1400 mg) | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 753 | 163 | Not reported | Not reported | Not reported |
| PART 1 Dose 2 (20 mg) | 1520 | 225 | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 5620 | 3280 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 14300 | 7740 | Not reported | Not reported | Not reported |
| PART 1 Dose 5 (350 mg) | 29400 | 18400 | Not reported | Not reported | Not reported |
| PART 1 Dose 6 (700 mg) | 77800 | 27900 | Not reported | Not reported | Not reported |
| PART 1 Dose 7 (1400 mg) | 163000 | 32900 | Not reported | Not reported | Not reported |
cycle 4
| Group | Source count |
|---|---|
| PART 1 Dose 1 (7 mg) | 3 |
| PART 1 Dose 2 (20 mg) | 2 |
| PART 1 Dose 3 (70 mg) | 12 |
| PART 1 Dose 4 (200 mg) | 12 |
| PART 1 Dose 5 (350 mg) | 8 |
| PART 1 Dose 6 (700 mg) | 3 |
| PART 1 Dose 7 (1400 mg) | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 895 | 80.2 | Not reported | Not reported | Not reported |
| PART 1 Dose 2 (20 mg) | 1780 | 318 | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 5110 | 2850 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 17900 | 13200 | Not reported | Not reported | Not reported |
| PART 1 Dose 5 (350 mg) | 42200 | 28500 | Not reported | Not reported | Not reported |
| PART 1 Dose 6 (700 mg) | 84600 | 17700 | Not reported | Not reported | Not reported |
| PART 1 Dose 7 (1400 mg) | 282000 | 165000 | 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) | 4 |
| PART 1 Dose 5 (350 mg) | 3 |
| 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) | 785 | 39.6 | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 9150 | 2420 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 19600 | 13100 | Not reported | Not reported | Not reported |
| PART 1 Dose 5 (350 mg) | 43400 | 26500 | Not reported | Not reported | Not reported |
cycle 7
| Group | Source count |
|---|---|
| PART 1 Dose 1 (7 mg) | 0 |
| PART 1 Dose 2 (20 mg) | 0 |
| PART 1 Dose 3 (70 mg) | 2 |
| PART 1 Dose 4 (200 mg) | 4 |
| 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 3 (70 mg) | 10200 | 2190 | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 21600 | 10600 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 202
- value
- 303
- group Id
- OG001
- spread
- 1570
- value
- 1890
- group Id
- OG002
- spread
- 1550
- value
- 3620
- group Id
- OG003
- spread
- 4510
- value
- 8880
- group Id
- OG004
- spread
- 8040
- value
- 17000
- group Id
- OG005
- spread
- 13000
- value
- 41000
- group Id
- OG006
- spread
- 19300
- value
- 117000
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 17
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 3
- units
- Participants
- title
- cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 163
- value
- 753
- group Id
- OG001
- spread
- 225
- value
- 1520
- group Id
- OG002
- spread
- 3280
- value
- 5620
- group Id
- OG003
- spread
- 7740
- value
- 14300
- group Id
- OG004
- spread
- 18400
- value
- 29400
- group Id
- OG005
- spread
- 27900
- value
- 77800
- group Id
- OG006
- spread
- 32900
- value
- 163000
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- units
- Participants
- title
- cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 80.2
- value
- 895
- group Id
- OG001
- spread
- 318
- value
- 1780
- group Id
- OG002
- spread
- 2850
- value
- 5110
- group Id
- OG003
- spread
- 13200
- value
- 17900
- group Id
- OG004
- spread
- 28500
- value
- 42200
- group Id
- OG005
- spread
- 17700
- value
- 84600
- group Id
- OG006
- spread
- 165000
- value
- 282000
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- units
- Participants
- title
- cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 39.6
- value
- 785
- group Id
- OG002
- spread
- 2420
- value
- 9150
- group Id
- OG003
- spread
- 13100
- value
- 19600
- group Id
- OG004
- spread
- 26500
- value
- 43400
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- cycle 6
- categories
- measurements
- group Id
- OG002
- spread
- 2190
- value
- 10200
- group Id
- OG003
- spread
- 10600
- value
- 21600
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- cycle 7
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 12
- group Id
- OG006
- value
- 4
- units
- Participants
- description
- To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
- 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
- Summary of Trough Concentrations(Cmin) of INCAGN01949
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice