TriangleNCT02323880 · OUTCOME
Area Under the Drug Concentration Curve of Selinexor
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- h*ng/ml
- Interval / dispersion
- Full Range
- Time frame
- Up to 2 days
What was measured
The median (min, max) of the area under the drug concentration curve evaluated at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose on day 1 for Selinexor by study part, schema, and dose level.
Analysis population: All eligible patients
Groups in this outcome
Part A: Dose Level 1
35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
Part A: Dose Level 1 (DL 1)
35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
Part A: Dose Level -1 (DL -1)
20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
Part A: Weekly Dose Level 1 (WDL 1)
45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Part A: Weekly Dose Level -1 (WDL -1)
35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Part B: Weekly Dose Level -1 (WDL -1)
35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
Part PK: Dose Level -1 (DL -1)
20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
Part PK: Weekly Dose Level -1 (WDL -1)
35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
| Group | Source count |
|---|---|
| Part A: Dose Level 1 | 6 |
| Part A: Dose Level 1 (DL 1) | 13 |
| Part A: Dose Level -1 (DL -1) | 6 |
| Part A: Weekly Dose Level 1 (WDL 1) | 6 |
| Part A: Weekly Dose Level -1 (WDL -1) | 6 |
| Part B: Weekly Dose Level -1 (WDL -1) | 10 |
| Part PK: Dose Level -1 (DL -1) | 6 |
| Part PK: Weekly Dose Level -1 (WDL -1) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Dose Level 1 | 5030 | Not reported | 3807.3 | 8789.4 | Not reported |
| Part A: Dose Level 1 (DL 1) | 4656.8 | Not reported | 3660.5 | 7285.5 | Not reported |
| Part A: Dose Level -1 (DL -1) | 2602.4 | Not reported | 2355.9 | 4889.3 | Not reported |
| Part A: Weekly Dose Level 1 (WDL 1) | 6173.2 | Not reported | 5401.1 | 9161.2 | Not reported |
| Part A: Weekly Dose Level -1 (WDL -1) | 7135.9 | Not reported | 4718.0 | 8665.6 | Not reported |
| Part B: Weekly Dose Level -1 (WDL -1) | 4666.9 | Not reported | 2154.7 | 10151.4 | Not reported |
| Part PK: Dose Level -1 (DL -1) | 3132.8 | Not reported | 2028.5 | 3377.1 | Not reported |
| Part PK: Weekly Dose Level -1 (WDL -1) | 6505.5 | Not reported | 4739.7 | 8809.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3807.3
- upper Limit
- 8789.4
- value
- 5030
- group Id
- OG001
- lower Limit
- 3660.5
- upper Limit
- 7285.5
- value
- 4656.8
- group Id
- OG002
- lower Limit
- 2355.9
- upper Limit
- 4889.3
- value
- 2602.4
- group Id
- OG003
- lower Limit
- 5401.1
- upper Limit
- 9161.2
- value
- 6173.2
- group Id
- OG004
- lower Limit
- 4718.0
- upper Limit
- 8665.6
- value
- 7135.9
- group Id
- OG005
- lower Limit
- 2154.7
- upper Limit
- 10151.4
- value
- 4666.9
- group Id
- OG006
- lower Limit
- 2028.5
- upper Limit
- 3377.1
- value
- 3132.8
- group Id
- OG007
- lower Limit
- 4739.7
- upper Limit
- 8809.0
- value
- 6505.5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- units
- Participants
- description
- The median (min, max) of the area under the drug concentration curve evaluated at 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose on day 1 for Selinexor by study part, schema, and dose level.
- dispersion Type
- Full Range
- groups
- description
- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) of a 28 day, or 8 dose course (Pre-amendment #1)
- id
- OG000
- title
- Part A: Dose Level 1
- description
- 35 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
- id
- OG001
- title
- Part A: Dose Level 1 (DL 1)
- description
- 20 mg/m\^2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
- id
- OG002
- title
- Part A: Dose Level -1 (DL -1)
- description
- 45 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- id
- OG003
- title
- Part A: Weekly Dose Level 1 (WDL 1)
- description
- 35 mg/m2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- id
- OG004
- title
- Part A: Weekly Dose Level -1 (WDL -1)
- description
- 35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- id
- OG005
- title
- Part B: Weekly Dose Level -1 (WDL -1)
- description
- 20 mg/m2 of Selinexor PO twice weekly on a days 1 and 3 schedule (Mon/Wed, Tues/Thurs, or Wed/Fri) on Weeks 1-3, Week 4 rest, on a 28 day course
- id
- OG006
- title
- Part PK: Dose Level -1 (DL -1)
- description
- 35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- id
- OG007
- title
- Part PK: Weekly Dose Level -1 (WDL -1)
- param Type
- MEDIAN
- population Description
- All eligible patients
- reporting Status
- POSTED
- time Frame
- Up to 2 days
- title
- Area Under the Drug Concentration Curve of Selinexor
- type
- PRIMARY
- unit Of Measure
- h*ng/ml
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Preserved source evidence · Not medical advice