TriangleNCT01125293 · OUTCOME
Everolimus Maximum Tolerated Dose (MTD) Stage B [Phase I]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg
- Interval / dispersion
- Not reported
- Time frame
- Assessed within the first cycle (28 days) of the study.
What was measured
The MTD of Everolimus/Bortezomib/Rituximab combination is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition. MTD is defined as the highest dose where \<1/3 participants experience a DLT. If no DLT's are observed on Level 1, 3 subjects will be enrolled in the Level 2. If \>1/3 subjects in a cohort have DLT, that dose will not be considered safe, with no escalation (MTD exceeded). If 1/3 subjects experience DLT, the cohort will be expanded to 6 subjects. If \<2 subjects with a DLT among the expanded cohort of 6 evaluable subjects a cohort of 3 subjects will be enrolled in the next higher dose level. If 2 or more subjects with a DLT among the expanded cohort of 6 subjects, that dose level will not be considered safe, no escalation (MTD exceeded).If no DLT's observed, then the MTD is not reached. The MTD was not reached with 0/3 participants experiencing a DLT in the highest level. Higher doses were not planned/tested.
Analysis population: In Phase I Stage B Level 1, one participant was replaced as an exception granted to the principal investigator having experienced a dose delay due to an adverse event not deemed a DLT.
Groups in this outcome
Phase I Stage B Level 1 & 2 and Dose Expansion
Combination of everolimus \& rituximab with bortezomib for 6 cycles Level 1: Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle) Level 2 and Dose Expansion: Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Level 1 \& 2 and Dose Expansion: Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Level 1 \& 2 and Dose Expansion: Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
| Group | Source count |
|---|---|
| Phase I Stage B Level 1 & 2 and Dose Expansion | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Stage B Level 1 & 2 and Dose Expansion | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- The MTD of Everolimus/Bortezomib/Rituximab combination is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition. MTD is defined as the highest dose where \<1/3 participants experience a DLT. If no DLT's are observed on Level 1, 3 subjects will be enrolled in the Level 2. If \>1/3 subjects in a cohort have DLT, that dose will not be considered safe, with no escalation (MTD exceeded). If 1/3 subjects experience DLT, the cohort will be expanded to 6 subjects. If \<2 subjects with a DLT among the expanded cohort of 6 evaluable subjects a cohort of 3 subjects will be enrolled in the next higher dose level. If 2 or more subjects with a DLT among the expanded cohort of 6 subjects, that dose level will not be considered safe, no escalation (MTD exceeded).If no DLT's observed, then the MTD is not reached. The MTD was not reached with 0/3 participants experiencing a DLT in the highest level. Higher doses were not planned/tested.
- groups
- description
- Combination of everolimus \& rituximab with bortezomib for 6 cycles Level 1: Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle) Level 2 and Dose Expansion: Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle) Level 1 \& 2 and Dose Expansion: Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days) Level 1 \& 2 and Dose Expansion: Bortezomib 1.6 mg/m\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)
- id
- OG000
- title
- Phase I Stage B Level 1 & 2 and Dose Expansion
- param Type
- NUMBER
- population Description
- In Phase I Stage B Level 1, one participant was replaced as an exception granted to the principal investigator having experienced a dose delay due to an adverse event not deemed a DLT.
- reporting Status
- POSTED
- time Frame
- Assessed within the first cycle (28 days) of the study.
- title
- Everolimus Maximum Tolerated Dose (MTD) Stage B [Phase I]
- type
- PRIMARY
- unit Of Measure
- mg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice