TriangleNCT00903968 · OUTCOME
Plerixafor Maximum Tolerated Dose (MTD) [Phase I]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- ug/kg
- Interval / dispersion
- Not reported
- Time frame
- Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
What was measured
The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of plerixafor was given on days 1, 2, 3, 6, 10, 13 of 21 each cycle.
Analysis population: All Phase I participants who received at least one dose of the study drug were evaluable for MTD.
Groups in this outcome
All Phase I Particiapnts
All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| All Phase I Particiapnts | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Phase I Particiapnts | 320 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 320
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of plerixafor was given on days 1, 2, 3, 6, 10, 13 of 21 each cycle.
- groups
- description
- All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
- id
- OG000
- title
- All Phase I Particiapnts
- param Type
- NUMBER
- population Description
- All Phase I participants who received at least one dose of the study drug were evaluable for MTD.
- reporting Status
- POSTED
- time Frame
- Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
- title
- Plerixafor Maximum Tolerated Dose (MTD) [Phase I]
- type
- PRIMARY
- unit Of Measure
- ug/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice