TriangleNCT00963820 · OUTCOME
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Days 1 and 15 of Cycle 1
What was measured
Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).
Analysis population: Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.
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 | 1.50 | Not reported | 1.50 | 1.50 | Not reported |
| 0.48 mg/m^2 | 1.53 | Not reported | 1.53 | 1.53 | Not reported |
| 0.80 mg/m^2 | 1.52 | Not reported | 1.03 | 2.00 | Not reported |
| 1.20 mg/m^2 | 1.00 | Not reported | 1.00 | 1.00 | Not reported |
| 1.68 mg/m^2 | 1.52 | Not reported | 1.00 | 2.00 | Not reported |
| 2.23 mg/m^2 | 1.25 | Not reported | 1.00 | 1.50 | Not reported |
| 2.97 mg/m^2 | 1.00 | Not reported | 0.50 | 4.00 | Not reported |
| 3.95 mg/m^2 | 1.00 | Not reported | 0.53 | 1.50 | Not reported |
| Relapsed and Refractory (RR) | 2.00 | Not reported | 0.50 | 2.00 | Not reported |
| VELCADE-relapsed (VR) | 0.50 | Not reported | 0.50 | 2.00 | Not reported |
| PI naïve | 1.00 | Not reported | 0.50 | 1.42 | Not reported |
| Carfilzomib | 1.42 | Not reported | 1.00 | 1.53 | 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 | 1.07 | Not reported | 1.00 | 2.00 | Not reported |
| 0.48 mg/m^2 | 0.50 | Not reported | 0.50 | 0.50 | Not reported |
| 0.80 mg/m^2 | 1.83 | Not reported | 1.00 | 2.00 | Not reported |
| 1.20 mg/m^2 | 1.00 | Not reported | 1.00 | 1.00 | Not reported |
| 1.68 mg/m^2 | 1.27 | Not reported | 1.00 | 1.53 | Not reported |
| 2.23 mg/m^2 | 8.00 | Not reported | 8.00 | 8.00 | Not reported |
| 2.97 mg/m^2 | 1.25 | Not reported | 0.50 | 2.00 | Not reported |
| 3.95 mg/m^2 | 1.03 | Not reported | 1.03 | 1.03 | Not reported |
| Relapsed and Refractory (RR) | 1.50 | Not reported | 1.00 | 4.03 | Not reported |
| VELCADE-relapsed (VR) | 1.00 | Not reported | 0.50 | 1.50 | Not reported |
| PI naïve | 1.00 | Not reported | 0.50 | 1.50 | Not reported |
| Carfilzomib | 1.03 | Not reported | 1.00 | 4.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.50
- upper Limit
- 1.50
- value
- 1.50
- group Id
- OG001
- lower Limit
- 1.53
- upper Limit
- 1.53
- value
- 1.53
- group Id
- OG002
- lower Limit
- 1.03
- upper Limit
- 2.00
- value
- 1.52
- group Id
- OG003
- lower Limit
- 1.00
- upper Limit
- 1.00
- value
- 1.00
- group Id
- OG004
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.52
- group Id
- OG005
- lower Limit
- 1.00
- upper Limit
- 1.50
- value
- 1.25
- group Id
- OG006
- lower Limit
- 0.50
- upper Limit
- 4.00
- value
- 1.00
- group Id
- OG007
- lower Limit
- 0.53
- upper Limit
- 1.50
- value
- 1.00
- group Id
- OG008
- lower Limit
- 0.50
- upper Limit
- 2.00
- value
- 2.00
- group Id
- OG009
- lower Limit
- 0.50
- upper Limit
- 2.00
- value
- 0.50
- group Id
- OG010
- lower Limit
- 0.50
- upper Limit
- 1.42
- value
- 1.00
- group Id
- OG011
- lower Limit
- 1.00
- upper Limit
- 1.53
- value
- 1.42
- title
- Cycle 1 Day 1 (n=1,1,2,1,3,2,5,4,5,8,5,3)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.07
- group Id
- OG001
- lower Limit
- 0.50
- upper Limit
- 0.50
- value
- 0.50
- group Id
- OG002
- lower Limit
- 1.00
- upper Limit
- 2.00
- value
- 1.83
- group Id
- OG003
- lower Limit
- 1.00
- upper Limit
- 1.00
- value
- 1.00
- group Id
- OG004
- lower Limit
- 1.00
- upper Limit
- 1.53
- value
- 1.27
- group Id
- OG005
- lower Limit
- 8.00
- upper Limit
- 8.00
- value
- 8.00
- group Id
- OG006
- lower Limit
- 0.50
- upper Limit
- 2.00
- value
- 1.25
- group Id
- OG007
- lower Limit
- 1.03
- upper Limit
- 1.03
- value
- 1.03
- group Id
- OG008
- lower Limit
- 1.00
- upper Limit
- 4.03
- value
- 1.50
- group Id
- OG009
- lower Limit
- 0.50
- upper Limit
- 1.50
- value
- 1.00
- group Id
- OG010
- lower Limit
- 0.50
- upper Limit
- 1.50
- value
- 1.00
- group Id
- OG011
- lower Limit
- 1.00
- upper Limit
- 4.00
- value
- 1.03
- 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
- Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.
- reporting Status
- POSTED
- time Frame
- Days 1 and 15 of Cycle 1
- title
- Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238
- type
- SECONDARY
- unit Of Measure
- hours
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