TriangleNCT02525692 · OUTCOME
Percent of Patients With Probability of Progression-Free Survival at 6 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Progression-free survival assessments were conducted 6 months following treatment initiation.
What was measured
Progression-free survival rate at 6 months was defined as the percentage of patients who exhibit progression-free survival for \>6 months.
Analysis population: Note: In Arm B, one participant with recurrent H3 K27M-mutant glioblastoma and non-measurable disease experienced complete regression of enhancing lesions for \>1.5 years was censored from analysis due to use of anastrozole at baseline and throughout the study.
Groups in this outcome
Arm A
Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences. Patients received 625 mg oral ONC201 once every 3 weeks.
Arm B
Patients with first recurrence of histologically confirmed WHO Grade IV glioma. Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
Arm C
Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
Arm D
Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed). Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
Arm E
Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
Arm F
Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status. Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
| Group | Source count |
|---|---|
| Arm A | 17 |
| Arm B | 19 |
| Arm C | 8 |
| Arm D | 30 |
| Arm E | 3 |
| Arm F | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A | 11.8 | Not reported | 2.0 | 31.2 | Not reported |
| Arm B | 0 | Not reported | NA | NA | Not calculated due to insufficient number of participants with events. |
| Arm C | NA | Not reported | NA | NA | Not calculated. By design, all patients in this cohort had surgery shortly after initiation of dordaviprone (ONC201) with no preceding post-baseline assessment; hence, all patients are censored for PFS at baseline. |
| Arm D | 14.5 | Not reported | 4.6 | 29.8 | Not reported |
| Arm E | 0 | Not reported | NA | NA | Not calculated due to insufficient number of participants with events. |
| Arm F | 14.3 | Not reported | 0.7 | 46.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 31.2
- value
- 11.8
- comment
- Not calculated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- Not calculated. By design, all patients in this cohort had surgery shortly after initiation of dordaviprone (ONC201) with no preceding post-baseline assessment; hence, all patients are censored for PFS at baseline.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 4.6
- upper Limit
- 29.8
- value
- 14.5
- comment
- Not calculated due to insufficient number of participants with events.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG005
- lower Limit
- 0.7
- upper Limit
- 46.5
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- Progression-free survival rate at 6 months was defined as the percentage of patients who exhibit progression-free survival for \>6 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences. Patients received 625 mg oral ONC201 once every 3 weeks.
- id
- OG000
- title
- Arm A
- description
- Patients with first recurrence of histologically confirmed WHO Grade IV glioma. Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
- id
- OG001
- title
- Arm B
- description
- Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
- id
- OG002
- title
- Arm C
- description
- Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed). Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
- id
- OG003
- title
- Arm D
- description
- Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection. Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
- id
- OG004
- title
- Arm E
- description
- Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status. Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
- id
- OG005
- title
- Arm F
- param Type
- NUMBER
- population Description
- Note: In Arm B, one participant with recurrent H3 K27M-mutant glioblastoma and non-measurable disease experienced complete regression of enhancing lesions for \>1.5 years was censored from analysis due to use of anastrozole at baseline and throughout the study.
- reporting Status
- POSTED
- time Frame
- Progression-free survival assessments were conducted 6 months following treatment initiation.
- title
- Percent of Patients With Probability of Progression-Free Survival at 6 Months
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice