TriangleNCT02639546 · OUTCOME
PFS as Determined by the Investigator Using RANO Criteria for Participants With HGG (Phase I) and RECIST v1.1 for Partcipants With LGG (Phase I and II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)
What was measured
Tumor assessment was performed using RANO for participants with HGG and RECIST v1.1 for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.
Analysis population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
Groups in this outcome
High Grade Glioma
Participants with High Grade Glioma.
Low Grade Glioma
Participants with Low Grade Glioma.
| Group | Source count |
|---|---|
| High Grade Glioma | 5 |
| Low Grade Glioma | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| High Grade Glioma | 1.0 | Not reported | 0.6 | NA | The upper limit could not be calculated from the data due to insufficient number of participants with events. |
| Low Grade Glioma | 22.0 | Not reported | 9.3 | NA | The upper limit could not be calculated from the data due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit could not be calculated from the data due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- NA
- value
- 1.0
- comment
- The upper limit could not be calculated from the data due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 9.3
- upper Limit
- NA
- value
- 22.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 32
- units
- Participants
- description
- Tumor assessment was performed using RANO for participants with HGG and RECIST v1.1 for participants with LGG. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with High Grade Glioma.
- id
- OG000
- title
- High Grade Glioma
- description
- Participants with Low Grade Glioma.
- id
- OG001
- title
- Low Grade Glioma
- param Type
- MEDIAN
- population Description
- The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
- reporting Status
- POSTED
- time Frame
- From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)
- title
- PFS as Determined by the Investigator Using RANO Criteria for Participants With HGG (Phase I) and RECIST v1.1 for Partcipants With LGG (Phase I and II)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice