TriangleNCT02046070 · OUTCOME
Cmax: Maximum Observed Plasma Concentration for Ixazomib in NDMM Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanogram/mL (ng/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
Analysis population: PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.
Groups in this outcome
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 6 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 64.283 | 36.283 | Not reported | Not reported | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 46.600 | 34.7722 | Not reported | Not reported | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 6 |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM) | 53.145 | 46.3782 | Not reported | Not reported | Not reported |
| Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM) | 62.280 | 39.4249 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 36.283
- value
- 64.283
- group Id
- OG001
- spread
- 34.7722
- value
- 46.600
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 46.3782
- value
- 53.145
- group Id
- OG001
- spread
- 39.4249
- value
- 62.280
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
- id
- OG000
- title
- Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)
- description
- Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\] and cyclophosphamide (CYC) 400 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.
- id
- OG001
- title
- Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)
- param Type
- MEAN
- population Description
- PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose
- title
- Cmax: Maximum Observed Plasma Concentration for Ixazomib in NDMM Participants
- type
- SECONDARY
- unit Of Measure
- nanogram/mL (ng/mL)
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Preserved source evidence · Not medical advice