TriangleNCT02684058 · OUTCOME
HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria
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
- Up to approx. 3.2 years and up to approx. 4.8 years
What was measured
Time from first documented response (PR or CR) until disease progression or death as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
Analysis population: Participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment with a confirmed CR or PR as per investigator assessment using RANO criteria
Groups in this outcome
HGG Cohort: Dabrafenib and Trametinib
Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
| Group | Source count |
|---|---|
| HGG Cohort: Dabrafenib and Trametinib | 25 |
Reported measurements
Up to approx. 3.2 years
| Group | Source count |
|---|---|
| HGG Cohort: Dabrafenib and Trametinib | 24 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HGG Cohort: Dabrafenib and Trametinib | 26.6 | Not reported | 14.9 | NA | Not estimable (NA) due to the insufficient number of participants with events |
Up to approx. 4.8 years
| Group | Source count |
|---|---|
| HGG Cohort: Dabrafenib and Trametinib | 25 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HGG Cohort: Dabrafenib and Trametinib | 32.7 | Not reported | 14.9 | NA | Not estimable (NA) due to the insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable (NA) due to the insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 14.9
- upper Limit
- NA
- value
- 26.6
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- title
- Up to approx. 3.2 years
- categories
- measurements
- comment
- Not estimable (NA) due to the insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 14.9
- upper Limit
- NA
- value
- 32.7
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- title
- Up to approx. 4.8 years
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- Time from first documented response (PR or CR) until disease progression or death as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants in the HGG cohort received dabrafenib (orally, twice daily and dosed based on weight and age) and trametinib (orally, once daily in combination with the first daily dose of dabrafenib and dosed based on weight)
- id
- OG000
- title
- HGG Cohort: Dabrafenib and Trametinib
- param Type
- MEDIAN
- population Description
- Participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment with a confirmed CR or PR as per investigator assessment using RANO criteria
- reporting Status
- POSTED
- time Frame
- Up to approx. 3.2 years and up to approx. 4.8 years
- title
- HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice