TriangleNCT02923349 · OUTCOME
Progression-free Survival Per RECIST and Modified RECIST
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- Baseline and every 8 weeks, up to 11 months
What was measured
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Analysis population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 57 | 55 | 55 | 59 | Not reported |
| PART 1 Dose 2 (20 mg) | 47.5 | 29 | 29 | 112 | Not reported |
| PART 1 Dose 3 (70 mg) | 54.0 | 23 | 23 | 216 | Not reported |
| PART 1 Dose 4 (200 mg) | 56.0 | 26 | 26 | 281 | Not reported |
| PART 1 Dose 5 (350 mg) | 52.0 | 1 | 1 | 166 | Not reported |
| PART 1 Dose 6 (700 mg) | 125.0 | 21 | 21 | 298 | Not reported |
| PART 1 Dose 7 (1400 mg) | 46.5 | 42 | 42 | 53 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 55
- spread
- 55
- upper Limit
- 59
- value
- 57
- group Id
- OG001
- lower Limit
- 29
- spread
- 29
- upper Limit
- 112
- value
- 47.5
- group Id
- OG002
- lower Limit
- 23
- spread
- 23
- upper Limit
- 216
- value
- 54.0
- group Id
- OG003
- lower Limit
- 26
- spread
- 26
- upper Limit
- 281
- value
- 56.0
- group Id
- OG004
- lower Limit
- 1
- spread
- 1
- upper Limit
- 166
- value
- 52.0
- group Id
- OG005
- lower Limit
- 21
- spread
- 21
- upper Limit
- 298
- value
- 125.0
- group Id
- OG006
- lower Limit
- 42
- spread
- 42
- upper Limit
- 53
- value
- 46.5
- 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
- ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
- 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 Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
- reporting Status
- POSTED
- time Frame
- Baseline and every 8 weeks, up to 11 months
- title
- Progression-free Survival Per RECIST and Modified RECIST
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice