TriangleNCT01607892 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of Selinexor
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
What was measured
Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.
Analysis population: Pharmacokinetic (PK) analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for cycle 1 day1 (C1D1) could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
Groups in this outcome
Selinexor (3 mg/m^2)
Participants received selinexor dose of 3 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Selinexor (6 mg/m^2)
Participants received selinexor dose of 6 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Selinexor (12 mg/m^2)
Participants received selinexor dose of 12 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
Selinexor (16.8 mg/m^2)
Participants received selinexor dose of 16.8 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
Selinexor (23 mg/m^2)
Participants received selinexor dose of 23 mg/m\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
Selinexor (30 mg/m^2)
Participants received selinexor dose of 30 mg/m\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
Selinexor (35 mg/m^2)
Participants received selinexor dose of 35 mg/m\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
Selinexor (40 mg/m^2)
Participants received selinexor dose of 40 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
Selinexor (46 mg/m^2)
Participants received selinexor dose of 46 mg/m\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
Selinexor (55 mg/m^2)
Participants received selinexor dose of 55 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
Selinexor (60 mg/m^2)
Participants received selinexor dose of 60 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Selinexor (70 mg/m^2)
Participants received selinexor dose of 70 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
Selinexor (80 mg/m^2)
Participants received selinexor dose of 80 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
| Group | Source count |
|---|---|
| Selinexor (3 mg/m^2) | 2 |
| Selinexor (6 mg/m^2) | 3 |
| Selinexor (12 mg/m^2) | 6 |
| Selinexor (16.8 mg/m^2) | 13 |
| Selinexor (23 mg/m^2) | 18 |
| Selinexor (30 mg/m^2) | 21 |
| Selinexor (35 mg/m^2) | 13 |
| Selinexor (40 mg/m^2) | 8 |
| Selinexor (46 mg/m^2) | 9 |
| Selinexor (55 mg/m^2) | 8 |
| Selinexor (60 mg/m^2) | 4 |
| Selinexor (70 mg/m^2) | 8 |
| Selinexor (80 mg/m^2) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selinexor (3 mg/m^2) | 49.0 | NA | Not reported | Not reported | Geometric coefficient of variation (CV) was not calculated as data were available for only two participants. |
| Selinexor (6 mg/m^2) | 50.0 | 61.1 | Not reported | Not reported | Not reported |
| Selinexor (12 mg/m^2) | 149 | 37.6 | Not reported | Not reported | Not reported |
| Selinexor (16.8 mg/m^2) | 205 | 46.8 | Not reported | Not reported | Not reported |
| Selinexor (23 mg/m^2) | 262 | 37.5 | Not reported | Not reported | Not reported |
| Selinexor (30 mg/m^2) | 387 | 37.1 | Not reported | Not reported | Not reported |
| Selinexor (35 mg/m^2) | 407 | 44.4 | Not reported | Not reported | Not reported |
| Selinexor (40 mg/m^2) | 416 | 36.6 | Not reported | Not reported | Not reported |
| Selinexor (46 mg/m^2) | 670 | 18.5 | Not reported | Not reported | Not reported |
| Selinexor (55 mg/m^2) | 583 | 41.4 | Not reported | Not reported | Not reported |
| Selinexor (60 mg/m^2) | 668 | 33.2 | Not reported | Not reported | Not reported |
| Selinexor (70 mg/m^2) | 800 | 32.4 | Not reported | Not reported | Not reported |
| Selinexor (80 mg/m^2) | 1068 | 49.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric coefficient of variation (CV) was not calculated as data were available for only two participants.
- group Id
- OG000
- spread
- NA
- value
- 49.0
- group Id
- OG001
- spread
- 61.1
- value
- 50.0
- group Id
- OG002
- spread
- 37.6
- value
- 149
- group Id
- OG003
- spread
- 46.8
- value
- 205
- group Id
- OG004
- spread
- 37.5
- value
- 262
- group Id
- OG005
- spread
- 37.1
- value
- 387
- group Id
- OG006
- spread
- 44.4
- value
- 407
- group Id
- OG007
- spread
- 36.6
- value
- 416
- group Id
- OG008
- spread
- 18.5
- value
- 670
- group Id
- OG009
- spread
- 41.4
- value
- 583
- group Id
- OG010
- spread
- 33.2
- value
- 668
- group Id
- OG011
- spread
- 32.4
- value
- 800
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 8
- units
- Participants
- description
- Cmax was defined as the maximum observed concentration, taken directly from the plasma concentration.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received selinexor dose of 3 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
- id
- OG000
- title
- Selinexor (3 mg/m^2)
- description
- Participants received selinexor dose of 6 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
- id
- OG001
- title
- Selinexor (6 mg/m^2)
- description
- Participants received selinexor dose of 12 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 10, 15, 17, 19, 22 and 24 in schedule 1.
- id
- OG002
- title
- Selinexor (12 mg/m^2)
- description
- Participants received selinexor dose of 16.8 mg/m\^2 orally at Cycle 1, on Day 1, 3, 5, 8, 15, 17, 19, and 22 in schedule 2.
- id
- OG003
- title
- Selinexor (16.8 mg/m^2)
- description
- Participants received selinexor dose of 23 mg/m\^2 orally at Cycle 1, on Day 1 and 2 of each week for a 28-day cycle in schedule 4.
- id
- OG004
- title
- Selinexor (23 mg/m^2)
- description
- Participants received selinexor dose of 30 mg/m\^2 orally at Cycle 1, on Day 1, 3, 4, 8, 10, 15 and 17 in schedule 3, 5 and 9.
- id
- OG005
- title
- Selinexor (30 mg/m^2)
- description
- Participants received selinexor dose of 35 mg/m\^2 orally at Cycle 1, on Day 1 and 3 in schedule 6.
- id
- OG006
- title
- Selinexor (35 mg/m^2)
- description
- Participants received selinexor dose of 40 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, 17 followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 8 and 11.
- id
- OG007
- title
- Selinexor (40 mg/m^2)
- description
- Participants received selinexor dose of 46 mg/m\^2 orally at Cycle 1, on Day 1 once-weekly in schedule 7.
- id
- OG008
- title
- Selinexor (46 mg/m^2)
- description
- Participants received selinexor dose of 55 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, and 10, followed by an 18-day treatment-free interval (Days 11 through 28) in schedule 10.
- id
- OG009
- title
- Selinexor (55 mg/m^2)
- description
- Participants received selinexor dose of 60 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
- id
- OG010
- title
- Selinexor (60 mg/m^2)
- description
- Participants received selinexor dose of 70 mg/m\^2 orally at Cycle 1, on Day 1, 3, 8, 10, 15, and 17, followed by an 11-day treatment-free interval (Days 18 through 28) in schedule 11.
- id
- OG011
- title
- Selinexor (70 mg/m^2)
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) analysis was defined as all participants who received active drug, selinexor, without the co-administration of another chemotherapeutic (i.e., rituximab), and for whom the PK profile for cycle 1 day1 (C1D1) could be adequately characterized. Here 'Overall Number of Participants Analyzed' signifies number of participants analyzed for this outcome measure.
- reporting Status
- POSTED
- time Frame
- 0 (pre-dose), 0.5, 1, 2, 4, 8, 24 and 48 hours post-dose on Day 1, 8 of Cycle 1 and Days 15, 16 or 17 of Cycle 2
- title
- Maximum Observed Plasma Concentration (Cmax) of Selinexor
- type
- SECONDARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
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Preserved source evidence · Not medical advice