TriangleNCT01318902 · OUTCOME
Cmax: Maximum Observed Plasma Concentration for Ixazomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr
Analysis population: Pharmacokinetic (PK) analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.
Groups in this outcome
Ixazomib 4.0 mg
Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1 and 15 during each 28-day treatment cycle for all the participants from dose escalation and expansion cohorts were evaluated in this arm group. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
Ixazomib 5.5 mg
Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone was added on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. The maximum duration of treatment was up to 12 cycles.
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg | 20 |
| Ixazomib 5.5 mg | 2 |
Reported measurements
Cycle 1, Day 1
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg | 15 |
| Ixazomib 5.5 mg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg | 54.00 | Not reported | 16.7 | 163.0 | Not reported |
Cycle 1, Day 15
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg | 18 |
| Ixazomib 5.5 mg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg | 51.26 | Not reported | 10.7 | 131.0 | Not reported |
| Ixazomib 5.5 mg | 92.20 | Not reported | 61.4 | 123.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.7
- upper Limit
- 163.0
- value
- 54.00
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Cycle 1, Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.7
- upper Limit
- 131.0
- value
- 51.26
- group Id
- OG001
- lower Limit
- 61.4
- upper Limit
- 123.0
- value
- 92.20
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 1, Day 15
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 2
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Ixazomib 4.0 mg, capsule, orally, once weekly on Days 1 and 15 during each 28-day treatment cycle for all the participants from dose escalation and expansion cohorts were evaluated in this arm group. Duration of treatment was up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
- id
- OG000
- title
- Ixazomib 4.0 mg
- description
- Ixazomib 5.5 mg, capsule, orally, once weekly on Days 1, 8 and 15 during each 28-day treatment cycle for 3 cycles. If there was no hematologic response, dexamethasone was added on Days 1 to 4 of every cycle, beginning in Cycle 4 for 3 additional cycles. The maximum duration of treatment was up to 12 cycles.
- id
- OG001
- title
- Ixazomib 5.5 mg
- param Type
- MEAN
- population Description
- Pharmacokinetic (PK) analysis population included all participants who received at least 1 dose of ixazomib and had sufficient ixazomib concentration-time data and dosing data to permit calculation of ixazomib plasma PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.
- reporting Status
- POSTED
- time Frame
- Cycle 1: Day 1 (MTD cohort participants only, 4.0 mg) and Day 15 (all participants enrolled in the study): predose (within 1 hour (hr) before dosing), and postdose at multiple timepoints up to 168 hr
- title
- Cmax: Maximum Observed Plasma Concentration for Ixazomib
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice