TriangleNCT03387020 · OUTCOME
Maximum Tolerated Dose of Ribociclib and Everolimus
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m^2/day
- Interval / dispersion
- Not reported
- Time frame
- 4 weeks
What was measured
Defined as the highest dose level at which six patients have been treated with at most one patient experiencing a dose limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. Will be estimated using a Rolling-6 phase I design. Only patients who are evaluable for DLT will be consider for estimating of Maximum Tolerated Dose. Patient who were enrolled under Surgical cohort but received sufficient study defined treatment would also be evaluable for DLT.
Analysis population: Patients who were evaluable for dose finding assessment were used to determine the MTD. Evaluable patients are those who were eligible, started treatment and either experienced a dose limiting toxicity during course 1 or received adequate amount of treatment and were followed adequately to be assessed for safety during course 1. Evaluable patients could be from either Phase I stratum or from Surgical stratum as long as they received sufficient protocol defined Phase I treatment.
Groups in this outcome
DLT Evaluable Set
Patients either from Phase I stratum and received treatment from beginning, or from Surgical stratum who subsequently received Phase I defined treatment would be evaluable for MTD as long as they received sufficient Phase I defined treatment. Of the patients enrolled in Phase I stratum, 11 of them were evaluable for dose finding assessment. Of the patients enrolled in Surgical stratum, 5 of them were evaluable for dose finding assessment. Therefore, we have total 16 patients evaluable for dose finding assessment, 11 from Phase I stratum and 5 from Surgical stratum.
| Group | Source count |
|---|---|
| DLT Evaluable Set | 16 |
Reported measurements
Ribociclib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DLT Evaluable Set | 120 | Not reported | Not reported | Not reported | Not reported |
Everolumus
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DLT Evaluable Set | 1.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 120
- title
- Ribociclib
- categories
- measurements
- group Id
- OG000
- value
- 1.2
- title
- Everolumus
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- description
- Defined as the highest dose level at which six patients have been treated with at most one patient experiencing a dose limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. Will be estimated using a Rolling-6 phase I design. Only patients who are evaluable for DLT will be consider for estimating of Maximum Tolerated Dose. Patient who were enrolled under Surgical cohort but received sufficient study defined treatment would also be evaluable for DLT.
- groups
- description
- Patients either from Phase I stratum and received treatment from beginning, or from Surgical stratum who subsequently received Phase I defined treatment would be evaluable for MTD as long as they received sufficient Phase I defined treatment. Of the patients enrolled in Phase I stratum, 11 of them were evaluable for dose finding assessment. Of the patients enrolled in Surgical stratum, 5 of them were evaluable for dose finding assessment. Therefore, we have total 16 patients evaluable for dose finding assessment, 11 from Phase I stratum and 5 from Surgical stratum.
- id
- OG000
- title
- DLT Evaluable Set
- param Type
- NUMBER
- population Description
- Patients who were evaluable for dose finding assessment were used to determine the MTD. Evaluable patients are those who were eligible, started treatment and either experienced a dose limiting toxicity during course 1 or received adequate amount of treatment and were followed adequately to be assessed for safety during course 1. Evaluable patients could be from either Phase I stratum or from Surgical stratum as long as they received sufficient protocol defined Phase I treatment.
- reporting Status
- POSTED
- time Frame
- 4 weeks
- title
- Maximum Tolerated Dose of Ribociclib and Everolimus
- type
- PRIMARY
- unit Of Measure
- mg/m^2/day
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice