TriangleNCT02323880 · OUTCOME
Radiographic Response of Selinexor in High-grade Glioma (HGG) Patients
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 6 years 11 months
What was measured
Number of HGG patients with radiographic response by study part, schema, and dose level.
Analysis population: high-grade glioma (HGG) 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: 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: 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 | 3 |
| Part A: Dose Level 1 (DL 1) | 3 |
| 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) | 9 |
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Dose Level 1 (DL 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Weekly Dose Level 1 (WDL 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Weekly Dose Level -1 (WDL -1) | 0 | 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: 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
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- Number of HGG patients with radiographic response 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
- 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
- 35 mg/m\^2 Selinexor once weekly, on days 1, 8, 15, and 22 of a 28-day cycle
- id
- OG005
- title
- Part PK: Weekly Dose Level -1 (WDL -1)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- high-grade glioma (HGG) patients
- reporting Status
- POSTED
- time Frame
- Up to 6 years 11 months
- title
- Radiographic Response of Selinexor in High-grade Glioma (HGG) Patients
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice