TriangleNCT02923349 · OUTCOME
Duration of Disease Control 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. Median was not estimable due to insufficient number of participants with CR, PR, and SD
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) | 1 |
| PART 1 Dose 2 (20 mg) | 1 |
| PART 1 Dose 3 (70 mg) | 8 |
| PART 1 Dose 4 (200 mg) | 7 |
| PART 1 Dose 5 (350 mg) | 3 |
| PART 1 Dose 6 (700 mg) | 7 |
| PART 1 Dose 7 (1400 mg) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 0 | Not reported | 0 | 0 | Not reported |
| PART 1 Dose 2 (20 mg) | 57 | Not reported | 57 | 57 | Not reported |
| PART 1 Dose 3 (70 mg) | 64 | Not reported | 1 | 160 | Not reported |
| PART 1 Dose 4 (200 mg) | 57 | Not reported | 1 | 225 | Not reported |
| PART 1 Dose 5 (350 mg) | NA | Not reported | 1 | 112 | The numbers reported were censored durations of stable disease for the participants. Median is not estimable as Kaplan-Meier method requires at least 1 event to determine where the curve hits 50% rate of estimated durations |
| PART 1 Dose 6 (700 mg) | 120 | Not reported | 1 | 249 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 57
- upper Limit
- 57
- value
- 57
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 160
- value
- 64
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 225
- value
- 57
- comment
- The numbers reported were censored durations of stable disease for the participants. Median is not estimable as Kaplan-Meier method requires at least 1 event to determine where the curve hits 50% rate of estimated durations
- group Id
- OG004
- lower Limit
- 1
- upper Limit
- 112
- value
- NA
- group Id
- OG005
- lower Limit
- 1
- upper Limit
- 249
- value
- 120
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 0
- 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. Median was not estimable due to insufficient number of participants with CR, PR, and SD
- reporting Status
- POSTED
- time Frame
- Baseline and every 8 weeks, up to 11 months
- title
- Duration of Disease Control 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