TriangleNCT05949632 · OUTCOME
Part 2: Objective Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- up to 2 years
What was measured
Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Analysis population: Full Analysis Set: all participants who received at least 1 dose of INCB099280 or axitinib. Analysis in the FAS was based on assigned dose. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted.
Groups in this outcome
INCB099280 400 mg BID Plus Axitinib 5 mg BID
Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
| Group | Source count |
|---|---|
| INCB099280 400 mg BID Plus Axitinib 5 mg BID | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
- groups
- description
- Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.
- id
- OG000
- title
- INCB099280 400 mg BID Plus Axitinib 5 mg BID
- population Description
- Full Analysis Set: all participants who received at least 1 dose of INCB099280 or axitinib. Analysis in the FAS was based on assigned dose. Enrollment in this study was closed during Part 1 following the sponsor's decision to discontinue the INCB099280 development program for strategic reasons. There were no safety concerns that contributed to the decision. Part 2 of the study was not conducted.
- reporting Status
- POSTED
- time Frame
- up to 2 years
- title
- Part 2: Objective Response
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice