TriangleNCT00560352 · OUTCOME
Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg QD
- Interval / dispersion
- Not reported
- Time frame
- Days 1 to 21
What was measured
MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.
Analysis population: All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
Groups in this outcome
All Treated
Dasatinib taken orally every day, once daily (QD) or twice daily (BID), depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
| Group | Source count |
|---|---|
| All Treated | 14 |
Reported measurements
MTD dasatinib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Treated | NA | Not reported | Not reported | Not reported | The MTD was not reached at the highest dose level defined by protocol for this study. |
Recommended MTD dasatinib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Treated | 140 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The MTD was not reached at the highest dose level defined by protocol for this study.
- group Id
- OG000
- value
- NA
- title
- MTD dasatinib
- categories
- measurements
- group Id
- OG000
- value
- 140
- title
- Recommended MTD dasatinib
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- MTD is defined as the dose level combination below the dose level that produces a dose-limiting toxicity in at least 2 out of 6 or fewer participants in that cohort. If MTD is not reached, the recommended MTD is the maximum dose that the participants received.
- groups
- description
- Dasatinib taken orally every day, once daily (QD) or twice daily (BID), depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
- id
- OG000
- title
- All Treated
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
- reporting Status
- POSTED
- time Frame
- Days 1 to 21
- title
- Maximum Tolerated Dose (MTD) and Recommended MTD of Dasatinib in Combination With Bortezomib and Dexamethasone
- type
- PRIMARY
- unit Of Measure
- mg QD
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice