TriangleNCT06056310 · OUTCOME
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 Criteria as Assessed by Investigator
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 approximately 6 months
What was measured
OR is defined as the number of participants who have a best overall response of complete response (CR) or partial response (PR) CR: Disappearance of target and non-target lesions and normalization of tumor markers. PR: At least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-progressive disease.
Analysis population: FAS included all participants who were administered any dose of any study intervention. As pre-specified in statistical analysis plan (SAP), efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure.
Groups in this outcome
Sequence 1
Participants received 3 cycles of oral solution of Xevinapant at adose of 200 milligrams per day (mg/day) once daily from Day 1 to14, per 3-week cycle. The first three cycles are given in combinationwith Cisplatin at dose of 40 milligrams per square meter (mg/m2)once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16,and C3D2) With 70 Gray (Gy) of intensity modulated radiationtherapy (IMRT) in 35 fractions, 2 Gy/fraction, 5 days/week followedby 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/dayfrom Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
| Group | Source count |
|---|---|
| Sequence 1 | 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
- OR is defined as the number of participants who have a best overall response of complete response (CR) or partial response (PR) CR: Disappearance of target and non-target lesions and normalization of tumor markers. PR: At least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Non target lesions must be non-progressive disease.
- groups
- description
- Participants received 3 cycles of oral solution of Xevinapant at adose of 200 milligrams per day (mg/day) once daily from Day 1 to14, per 3-week cycle. The first three cycles are given in combinationwith Cisplatin at dose of 40 milligrams per square meter (mg/m2)once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16,and C3D2) With 70 Gray (Gy) of intensity modulated radiationtherapy (IMRT) in 35 fractions, 2 Gy/fraction, 5 days/week followedby 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/dayfrom Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
- id
- OG000
- title
- Sequence 1
- population Description
- FAS included all participants who were administered any dose of any study intervention. As pre-specified in statistical analysis plan (SAP), efficacy analysis was not conducted in this study (samples were not processed) and therefore data could not be analyzed and reported in this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to approximately 6 months
- title
- Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 Criteria as Assessed by Investigator
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice