TriangleNCT00963820 · OUTCOME
Cmax: Maximum Observed Plasma Concentration for MLN2238
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
- Standard Deviation
- Time frame
- Days 1 and 15 of Cycle 1
What was measured
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).
Analysis population: Participants from the Pharmacokinetic (PK) Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of Cmax.
Groups in this outcome
0.24 mg/m^2
Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
0.48 mg/m^2
Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
0.80 mg/m^2
Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
1.20 mg/m^2
Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
1.68 mg/m^2
Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
2.23 mg/m^2
Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
2.97 mg/m^2
Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
3.95 mg/m^2
Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
Relapsed and Refractory (RR)
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
VELCADE-relapsed (VR)
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
PI naïve
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
Carfilzomib
Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
| Group | Source count |
|---|---|
| 0.24 mg/m^2 | 3 |
| 0.48 mg/m^2 | 1 |
| 0.80 mg/m^2 | 3 |
| 1.20 mg/m^2 | 2 |
| 1.68 mg/m^2 | 3 |
| 2.23 mg/m^2 | 2 |
| 2.97 mg/m^2 | 5 |
| 3.95 mg/m^2 | 4 |
| Relapsed and Refractory (RR) | 7 |
| VELCADE-relapsed (VR) | 8 |
| PI naïve | 5 |
| Carfilzomib | 3 |
Reported measurements
Cycle 1 Day 1 (n=1,1,2,1,3,2,5,4,5,8,5,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.24 mg/m^2 | 3.010 | NA | Not reported | Not reported | Can not be calculated for 1 participant. |
| 0.48 mg/m^2 | 2.91 | NA | Not reported | Not reported | Can not be calculated for 1 participant. |
| 0.80 mg/m^2 | 5.75 | 4.1083 | Not reported | Not reported | Not reported |
| 1.20 mg/m^2 | 15.10 | NA | Not reported | Not reported | Can not be calculated for 1 participant. |
| 1.68 mg/m^2 | 13.83 | 9.7070 | Not reported | Not reported | Not reported |
| 2.23 mg/m^2 | 29.05 | 11.1016 | Not reported | Not reported | Not reported |
| 2.97 mg/m^2 | 65.46 | 29.3351 | Not reported | Not reported | Not reported |
| 3.95 mg/m^2 | 123.95 | 79.2137 | Not reported | Not reported | Not reported |
| Relapsed and Refractory (RR) | 75.92 | 30.3995 | Not reported | Not reported | Not reported |
| VELCADE-relapsed (VR) | 110.43 | 62.7006 | Not reported | Not reported | Not reported |
| PI naïve | 77.70 | 37.9107 | Not reported | Not reported | Not reported |
| Carfilzomib | 83.73 | 87.8161 | Not reported | Not reported | Not reported |
Cycle 1 Day 15 (n=3,1,3,2,2,1,2,1,5,5,4,3)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.24 mg/m^2 | 3.64 | 0.9616 | Not reported | Not reported | Not reported |
| 0.48 mg/m^2 | 4.64 | NA | Not reported | Not reported | Can not be calculated for 1 participant. |
| 0.80 mg/m^2 | 6.89 | 5.1116 | Not reported | Not reported | Not reported |
| 1.20 mg/m^2 | 17.90 | 8.6267 | Not reported | Not reported | Not reported |
| 1.68 mg/m^2 | 17.63 | 12.6926 | Not reported | Not reported | Not reported |
| 2.23 mg/m^2 | 9.24 | NA | Not reported | Not reported | Can not be calculated for 1 participant. |
| 2.97 mg/m^2 | 100.55 | 15.1339 | Not reported | Not reported | Not reported |
| 3.95 mg/m^2 | 134.00 | NA | Not reported | Not reported | Can not be calculated for 1 participant. |
| Relapsed and Refractory (RR) | 50.46 | 22.6877 | Not reported | Not reported | Not reported |
| VELCADE-relapsed (VR) | 93.68 | 52.7617 | Not reported | Not reported | Not reported |
| PI naïve | 118.05 | 54.2907 | Not reported | Not reported | Not reported |
| Carfilzomib | 55.10 | 41.5275 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Can not be calculated for 1 participant.
- group Id
- OG000
- spread
- NA
- value
- 3.010
- comment
- Can not be calculated for 1 participant.
- group Id
- OG001
- spread
- NA
- value
- 2.91
- group Id
- OG002
- spread
- 4.1083
- value
- 5.75
- comment
- Can not be calculated for 1 participant.
- group Id
- OG003
- spread
- NA
- value
- 15.10
- group Id
- OG004
- spread
- 9.7070
- value
- 13.83
- group Id
- OG005
- spread
- 11.1016
- value
- 29.05
- group Id
- OG006
- spread
- 29.3351
- value
- 65.46
- group Id
- OG007
- spread
- 79.2137
- value
- 123.95
- group Id
- OG008
- spread
- 30.3995
- value
- 75.92
- group Id
- OG009
- spread
- 62.7006
- value
- 110.43
- group Id
- OG010
- spread
- 37.9107
- value
- 77.70
- group Id
- OG011
- spread
- 87.8161
- value
- 83.73
- title
- Cycle 1 Day 1 (n=1,1,2,1,3,2,5,4,5,8,5,3)
- categories
- measurements
- group Id
- OG000
- spread
- 0.9616
- value
- 3.64
- comment
- Can not be calculated for 1 participant.
- group Id
- OG001
- spread
- NA
- value
- 4.64
- group Id
- OG002
- spread
- 5.1116
- value
- 6.89
- group Id
- OG003
- spread
- 8.6267
- value
- 17.90
- group Id
- OG004
- spread
- 12.6926
- value
- 17.63
- comment
- Can not be calculated for 1 participant.
- group Id
- OG005
- spread
- NA
- value
- 9.24
- group Id
- OG006
- spread
- 15.1339
- value
- 100.55
- comment
- Can not be calculated for 1 participant.
- group Id
- OG007
- spread
- NA
- value
- 134.00
- group Id
- OG008
- spread
- 22.6877
- value
- 50.46
- group Id
- OG009
- spread
- 52.7617
- value
- 93.68
- group Id
- OG010
- spread
- 54.2907
- value
- 118.05
- group Id
- OG011
- spread
- 41.5275
- value
- 55.10
- title
- Cycle 1 Day 15 (n=3,1,3,2,2,1,2,1,5,5,4,3)
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).
- dispersion Type
- Standard Deviation
- groups
- description
- Ixazomib citrate, 0.24 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG000
- title
- 0.24 mg/m^2
- description
- Ixazomib citrate, 0.48 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG001
- title
- 0.48 mg/m^2
- description
- Ixazomib citrate, 0.80 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG002
- title
- 0.80 mg/m^2
- description
- Ixazomib citrate, 1.20 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG003
- title
- 1.20 mg/m^2
- description
- Ixazomib citrate, 1.68 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG004
- title
- 1.68 mg/m^2
- description
- Ixazomib citrate, 2.23 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG005
- title
- 2.23 mg/m^2
- description
- Ixazomib citrate, 2.97 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG006
- title
- 2.97 mg/m^2
- description
- Ixazomib citrate, 3.95 mg/m\^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG007
- title
- 3.95 mg/m^2
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG008
- title
- Relapsed and Refractory (RR)
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m\^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG009
- title
- VELCADE-relapsed (VR)
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG010
- title
- PI naïve
- description
- Ixazomib citrate, 2.97 mg/m\^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
- id
- OG011
- title
- Carfilzomib
- param Type
- MEAN
- population Description
- Participants from the Pharmacokinetic (PK) Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of Cmax.
- reporting Status
- POSTED
- time Frame
- Days 1 and 15 of Cycle 1
- title
- Cmax: Maximum Observed Plasma Concentration for MLN2238
- type
- SECONDARY
- unit Of Measure
- ng/mL
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