TriangleNCT01266967 · OUTCOME
Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks)
What was measured
OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PR) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.
Analysis population: V600E Population: all participants with BRAF V600E mutation-positive melanoma who received at least one dose of study treatment
Groups in this outcome
GSK2118436 150 mg: No Prior Local Therapy
Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
GSK2118436 150 mg: Prior Local Therapy
Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
| Group | Source count |
|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 74 |
| GSK2118436 150 mg: Prior Local Therapy | 65 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 4 | Not reported | Not reported | Not reported | Not reported |
| GSK2118436 150 mg: Prior Local Therapy | 1 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GSK2118436 150 mg: No Prior Local Therapy | 26 | Not reported | Not reported | Not reported | Not reported |
| GSK2118436 150 mg: Prior Local Therapy | 23 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 29.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 52.6
- estimate Comment
- The estimated value represents the percentage of participants with OIR.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- percentage of participants
- param Value
- 41
- statistical Method
- Exact Test
- tested Non Inferiority
- false
- ci Lower Limit
- 25.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 49.8
- estimate Comment
- The estimated value represents the percentage of participants with OIR.
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- percentage of participants
- param Value
- 37
- statistical Method
- Exact Test
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 29.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 52.6
- estimate Comment
- The estimated value represents the percentage of participants with OIR.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- percentage of participants
- param Value
- 41
- statistical Method
- Exact Test
- tested Non Inferiority
- false
- ci Lower Limit
- 25.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 49.8
- estimate Comment
- The estimated value represents the percentage of participants with OIR.
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- percentage of participants
- param Value
- 37
- statistical Method
- Exact Test
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 23
- title
- PR
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PR) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.
- groups
- description
- Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
- id
- OG000
- title
- GSK2118436 150 mg: No Prior Local Therapy
- description
- Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
- id
- OG001
- title
- GSK2118436 150 mg: Prior Local Therapy
- param Type
- NUMBER
- population Description
- V600E Population: all participants with BRAF V600E mutation-positive melanoma who received at least one dose of study treatment
- reporting Status
- POSTED
- time Frame
- From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks)
- title
- Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice