TriangleNCT02323880 · OUTCOME
Pharmacodynamics of Selinexor
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Ratio of XPO1 mRNA expression
- Interval / dispersion
- Full Range
- Time frame
- Up to 28 days
What was measured
Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
Analysis population: There were 0 (zero) patients from Part A: Dose Level 1 (Pre-amendment #1). Participation in the PD studies was optional. The subjects who had matched pre- and post-treatment blood samples were analyzed; not all the subjects had samples collected for PD analysis.
Groups in this outcome
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 (DL 1) | 1 |
| Part A: Dose Level -1 (DL -1) | 2 |
| Part A: Weekly Dose Level 1 (WDL 1) | 2 |
| Part A: Weekly Dose Level -1 (WDL -1) | 2 |
| Part B: Weekly Dose Level -1 (WDL -1) | 4 |
| Part PK: Dose Level -1 (DL -1) | 1 |
| Part PK: Weekly Dose Level -1 (WDL -1) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Dose Level 1 (DL 1) | 7.1 | Not reported | 7.1 | 7.1 | Not reported |
| Part A: Dose Level -1 (DL -1) | 4 | Not reported | 3.5 | 4.5 | Not reported |
| Part A: Weekly Dose Level 1 (WDL 1) | 5.5 | Not reported | 4.2 | 6.7 | Not reported |
| Part A: Weekly Dose Level -1 (WDL -1) | 1.7 | Not reported | 0.2 | 3.2 | Not reported |
| Part B: Weekly Dose Level -1 (WDL -1) | 4.6 | Not reported | 1.2 | 5.3 | Not reported |
| Part PK: Dose Level -1 (DL -1) | 7.9 | Not reported | 7.9 | 7.9 | Not reported |
| Part PK: Weekly Dose Level -1 (WDL -1) | 5.4 | Not reported | 5.0 | 5.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.1
- upper Limit
- 7.1
- value
- 7.1
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- 4.5
- value
- 4
- group Id
- OG002
- lower Limit
- 4.2
- upper Limit
- 6.7
- value
- 5.5
- group Id
- OG003
- lower Limit
- 0.2
- upper Limit
- 3.2
- value
- 1.7
- group Id
- OG004
- lower Limit
- 1.2
- upper Limit
- 5.3
- value
- 4.6
- group Id
- OG005
- lower Limit
- 7.9
- upper Limit
- 7.9
- value
- 7.9
- group Id
- OG006
- lower Limit
- 5.0
- upper Limit
- 5.9
- value
- 5.4
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- units
- Participants
- description
- Median (min,max) ratio of XPO1 mRNA expression after treatment to pre-treatment by study part, schema, and dose
- 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) on Weeks 1-3, Week 4 rest, on a 28 day course (Amendment 1)
- id
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- title
- Part PK: Weekly Dose Level -1 (WDL -1)
- param Type
- MEDIAN
- population Description
- There were 0 (zero) patients from Part A: Dose Level 1 (Pre-amendment #1). Participation in the PD studies was optional. The subjects who had matched pre- and post-treatment blood samples were analyzed; not all the subjects had samples collected for PD analysis.
- reporting Status
- POSTED
- time Frame
- Up to 28 days
- title
- Pharmacodynamics of Selinexor
- type
- SECONDARY
- unit Of Measure
- Ratio of XPO1 mRNA expression
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice