TriangleNCT00560391 · OUTCOME
Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
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
- From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
What was measured
The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in \< 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.
Analysis population: All treated participants, participants who received at least 1 dose of dasatinib.
Groups in this outcome
All Treated Participants
Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
| Group | Source count |
|---|---|
| All Treated Participants | 35 |
Reported measurements
RP2D of dasatinib in the combination
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Treated Participants | 140 | Not reported | Not reported | Not reported | Not reported |
RP2D of lenalidomide in the combination
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Treated Participants | 25 | Not reported | Not reported | Not reported | Not reported |
RP2D dexamethasone in the combination
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Treated Participants | 40 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 140
- title
- RP2D of dasatinib in the combination
- categories
- measurements
- group Id
- OG000
- value
- 25
- title
- RP2D of lenalidomide in the combination
- categories
- measurements
- group Id
- OG000
- value
- 40
- title
- RP2D dexamethasone in the combination
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in \< 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.
- groups
- description
- Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
- id
- OG000
- title
- All Treated Participants
- param Type
- NUMBER
- population Description
- All treated participants, participants who received at least 1 dose of dasatinib.
- reporting Status
- POSTED
- time Frame
- From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
- title
- Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
- type
- PRIMARY
- unit Of Measure
- mg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice