TriangleNCT02323880 · OUTCOME
Progression-free Survival of Selinexor in Surgical 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 months
What was measured
Number of surgical HGG patients with 6-month progression-free survival using the Response Evaluation Criteria in solid tumors criteria (RECIST v1.1) defining best response of progressive disease including at least 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and no prior stable disease, partial response, or complete response.
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: 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 | 3 |
| Part A: Dose Level 1 (DL 1) | 3 |
| Part A: Dose Level -1 (DL -1) | 0 |
| 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: Dose Level -1 (DL -1) | 0 |
| 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: 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: Dose Level -1 (DL -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
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 2
- units
- Participants
- description
- Number of surgical HGG patients with 6-month progression-free survival using the Response Evaluation Criteria in solid tumors criteria (RECIST v1.1) defining best response of progressive disease including at least 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and no prior stable disease, partial response, or complete response.
- 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
- high-grade glioma (HGG) patients
- reporting Status
- POSTED
- time Frame
- Up to 6 months
- title
- Progression-free Survival of Selinexor in Surgical High-grade Glioma (HGG) Patients
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice