TriangleNCT02323880 · OUTCOME
Number of Dose Limiting Toxicities of Selinexor
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 28 days
What was measured
The number of toxicity evaluable patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level.
Analysis population: Toxicity evaluable 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) | 12 |
| 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) | 7 |
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Dose Level 1 (DL 1) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part A: Dose Level -1 (DL -1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part A: Weekly Dose Level 1 (WDL 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: Weekly Dose Level -1 (WDL -1) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Weekly Dose Level -1 (WDL -1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part PK: Dose Level -1 (DL -1) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part PK: Weekly Dose Level -1 (WDL -1) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- units
- Participants
- description
- The number of toxicity evaluable patients experiencing a dose limiting toxicity at least possibly attributable to selinexor by study part, schema, and dose level.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Toxicity evaluable patients
- reporting Status
- POSTED
- time Frame
- Up to 28 days
- title
- Number of Dose Limiting Toxicities of Selinexor
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice