TriangleNCT02923349 · OUTCOME
Time to Maximum Concentration of INCAGN01949 in Plasma
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hr
- Interval / dispersion
- Full Range
- 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 Tmax 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) | 0.64 | Not reported | 0.6 | 4.4 | Not reported |
| PART 1 Dose 2 (20 mg) | 2.53 | Not reported | 0.55 | 4.5 | Not reported |
| PART 1 Dose 3 (70 mg) | 4.3 | Not reported | 0.50 | 25.2 | Not reported |
| PART 1 Dose 4 (200 mg) | 0.63 | Not reported | 0.5 | 4.5 | Not reported |
| PART 1 Dose 5 (350 mg) | 0.6 | Not reported | 0.0 | 194 | Not reported |
| PART 1 Dose 6 (700 mg) | 0.7 | Not reported | 0.53 | 4.2 | Not reported |
| PART 1 Dose 7 (1400 mg) | 0.73 | Not reported | 0.0 | 2.43 | 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) | 0.78 | Not reported | 0.75 | 0.8 | Not reported |
| PART 1 Dose 3 (70 mg) | 0.63 | Not reported | 0.50 | 4.3 | Not reported |
| PART 1 Dose 4 (200 mg) | 0.61 | Not reported | 0.55 | 4.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 4.4
- value
- 0.64
- group Id
- OG001
- lower Limit
- 0.55
- upper Limit
- 4.5
- value
- 2.53
- group Id
- OG002
- lower Limit
- 0.50
- upper Limit
- 25.2
- value
- 4.3
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 4.5
- value
- 0.63
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 194
- value
- 0.6
- group Id
- OG005
- lower Limit
- 0.53
- upper Limit
- 4.2
- value
- 0.7
- group Id
- OG006
- lower Limit
- 0.0
- upper Limit
- 2.43
- value
- 0.73
- 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
- lower Limit
- 0.75
- upper Limit
- 0.8
- value
- 0.78
- group Id
- OG002
- lower Limit
- 0.50
- upper Limit
- 4.3
- value
- 0.63
- group Id
- OG003
- lower Limit
- 0.55
- upper Limit
- 4.8
- value
- 0.61
- 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 Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
- dispersion Type
- Full Range
- 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
- MEDIAN
- 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
- Time to Maximum Concentration of INCAGN01949 in Plasma
- type
- SECONDARY
- unit Of Measure
- hr
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Preserved source evidence · Not medical advice