TriangleNCT01607892 · OUTCOME
Time to Maximum Observed Concentration (Tmax) of Selinexor
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour
- Interval / dispersion
- Full Range
- 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
Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
Analysis population: 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 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) | NA | Not reported | 2.1 | 2.2 | Median value was not calculated due to insufficient PK samples required for calculation. |
| Selinexor (6 mg/m^2) | 4.0 | Not reported | 2.1 | 7.7 | Not reported |
| Selinexor (12 mg/m^2) | 3.0 | Not reported | 1.1 | 4.2 | Not reported |
| Selinexor (16.8 mg/m^2) | 2.08 | Not reported | 0.92 | 8.5 | Not reported |
| Selinexor (23 mg/m^2) | 2.0 | Not reported | 1.0 | 7.8 | Not reported |
| Selinexor (30 mg/m^2) | 2.0 | Not reported | 0.72 | 4.4 | Not reported |
| Selinexor (35 mg/m^2) | 2.0 | Not reported | 0.92 | 4.1 | Not reported |
| Selinexor (40 mg/m^2) | 4.0 | Not reported | 2.0 | 7.5 | Not reported |
| Selinexor (46 mg/m^2) | 2.0 | Not reported | 0.50 | 4.2 | Not reported |
| Selinexor (55 mg/m^2) | 2.9 | Not reported | 1.0 | 8.0 | Not reported |
| Selinexor (60 mg/m^2) | 1.9 | Not reported | 1.8 | 2.0 | Not reported |
| Selinexor (70 mg/m^2) | 2.0 | Not reported | 1.0 | 4.0 | Not reported |
| Selinexor (80 mg/m^2) | 2.0 | Not reported | 0.5 | 4.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median value was not calculated due to insufficient PK samples required for calculation.
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 2.2
- value
- NA
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 7.7
- value
- 4.0
- group Id
- OG002
- lower Limit
- 1.1
- upper Limit
- 4.2
- value
- 3.0
- group Id
- OG003
- lower Limit
- 0.92
- upper Limit
- 8.5
- value
- 2.08
- group Id
- OG004
- lower Limit
- 1.0
- upper Limit
- 7.8
- value
- 2.0
- group Id
- OG005
- lower Limit
- 0.72
- upper Limit
- 4.4
- value
- 2.0
- group Id
- OG006
- lower Limit
- 0.92
- upper Limit
- 4.1
- value
- 2.0
- group Id
- OG007
- lower Limit
- 2.0
- upper Limit
- 7.5
- value
- 4.0
- group Id
- OG008
- lower Limit
- 0.50
- upper Limit
- 4.2
- value
- 2.0
- group Id
- OG009
- lower Limit
- 1.0
- upper Limit
- 8.0
- value
- 2.9
- group Id
- OG010
- lower Limit
- 1.8
- upper Limit
- 2.0
- value
- 1.9
- group Id
- OG011
- lower Limit
- 1.0
- upper Limit
- 4.0
- value
- 2.0
- 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
- Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- 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 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
- Time to Maximum Observed Concentration (Tmax) of Selinexor
- type
- SECONDARY
- unit Of Measure
- hour
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice