TriangleNCT05949632 · OUTCOME
Part 1: INCB099280 and Axitinib Plasma Concentrations
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
- Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
What was measured
Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed.
Analysis population: Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of either INB099280 or axitinib and provided at least 1 postbaseline sample for PK analysis. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future.
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
- Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed.
- 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
- Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of either INB099280 or axitinib and provided at least 1 postbaseline sample for PK analysis. Due to the expected limited number of PK samples from the 5 participants enrolled in this study, analysis of collected PK samples was not conducted, as pre-specified in the Statistical Analysis Plan. Collected samples will not be analyzed in the future.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
- title
- Part 1: INCB099280 and Axitinib Plasma Concentrations
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice