TriangleNCT02939183 · OUTCOME
Maximum Observed Concentration (Cmax) of Oprozomib
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
- Cycle 1 days 8 and 22: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose. GR only: cycle 1 day 8: 8 hours post-dose
What was measured
The mean Cmax of oprozomib is presented following dosing on cycle 1 day 8 and cycle 1 day 22 for the IR and GR oprozomib formulations.
Analysis population: Participants in the PK analysis set with data available at each time point. The PK analysis set included participants for whom at least 1 PK parameter could be adequately estimated, excluding roll-over participants.
Groups in this outcome
Oprozomib IR 150 mg/Day + Dexamethsone
In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib GR 150 mg/Day + Dexamethasone
In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
| Group | Source count |
|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 3 |
| Oprozomib GR 150 mg/Day + Dexamethasone | 6 |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 3 |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 3 |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 7 |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 5 |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 7 |
Reported measurements
Cycle 1 Day 8
| Group | Source count |
|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 3 |
| Oprozomib GR 150 mg/Day + Dexamethasone | 4 |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 3 |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 3 |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 7 |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 5 |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 321 | 89.2 | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 118 | 90.3 | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 349 | 195 | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 119 | 77.7 | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 694 | 479 | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 367 | 429 | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 1020 | 911 | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 800 | 703 | Not reported | Not reported | Not reported |
Cycle 1 Day 22
| Group | Source count |
|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 3 |
| Oprozomib GR 150 mg/Day + Dexamethasone | 6 |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 1 |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 3 |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 4 |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 4 |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 10 |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oprozomib IR 150 mg/Day + Dexamethsone | 453 | 48.0 | Not reported | Not reported | Not reported |
| Oprozomib GR 150 mg/Day + Dexamethasone | 209 | 185 | Not reported | Not reported | Not reported |
| Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone | 305 | NA | Not reported | Not reported | Standard deviation (SD) could not be determined due to too few participants with available data at this time point. |
| Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone | 191 | 99.2 | Not reported | Not reported | Not reported |
| Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone | 1040 | 941 | Not reported | Not reported | Not reported |
| Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone | 137 | 81.1 | Not reported | Not reported | Not reported |
| Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone | 1580 | 672 | Not reported | Not reported | Not reported |
| Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone | 1420 | 1250 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 89.2
- value
- 321
- group Id
- OG001
- spread
- 90.3
- value
- 118
- group Id
- OG002
- spread
- 195
- value
- 349
- group Id
- OG003
- spread
- 77.7
- value
- 119
- group Id
- OG004
- spread
- 479
- value
- 694
- group Id
- OG005
- spread
- 429
- value
- 367
- group Id
- OG006
- spread
- 911
- value
- 1020
- group Id
- OG007
- spread
- 703
- value
- 800
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 7
- units
- Participants
- title
- Cycle 1 Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 48.0
- value
- 453
- group Id
- OG001
- spread
- 185
- value
- 209
- comment
- Standard deviation (SD) could not be determined due to too few participants with available data at this time point.
- group Id
- OG002
- spread
- NA
- value
- 305
- group Id
- OG003
- spread
- 99.2
- value
- 191
- group Id
- OG004
- spread
- 941
- value
- 1040
- group Id
- OG005
- spread
- 81.1
- value
- 137
- group Id
- OG006
- spread
- 672
- value
- 1580
- group Id
- OG007
- spread
- 1250
- value
- 1420
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 4
- units
- Participants
- title
- Cycle 1 Day 22
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 7
- units
- Participants
- description
- The mean Cmax of oprozomib is presented following dosing on cycle 1 day 8 and cycle 1 day 22 for the IR and GR oprozomib formulations.
- dispersion Type
- Standard Deviation
- groups
- description
- In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG000
- title
- Oprozomib IR 150 mg/Day + Dexamethsone
- description
- In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
- id
- OG001
- title
- Oprozomib GR 150 mg/Day + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG002
- title
- Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG003
- title
- Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG004
- title
- Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG005
- title
- Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG006
- title
- Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
- description
- In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
- id
- OG007
- title
- Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
- param Type
- MEAN
- population Description
- Participants in the PK analysis set with data available at each time point. The PK analysis set included participants for whom at least 1 PK parameter could be adequately estimated, excluding roll-over participants.
- reporting Status
- POSTED
- time Frame
- Cycle 1 days 8 and 22: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose. GR only: cycle 1 day 8: 8 hours post-dose
- title
- Maximum Observed Concentration (Cmax) of Oprozomib
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice