TriangleNCT01072175 · OUTCOME
Part D: Duration of Response as Assessed by the Investigator
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
- First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 7 years)
What was measured
Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
Analysis population: ITT Population. Only those participants who had CR or PR were considered.
Groups in this outcome
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
Part D: Dabrafenib 75 mg + Trametinib 2 mg
Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
Part D: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
| Group | Source count |
|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 12 |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 16 |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 43 |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg | 8.2 | Not reported | 3.5 | 14.8 | Not reported |
| Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg | 10.1 | Not reported | 5.6 | NA | NA: Not estimable due to insufficient number of participants with events |
| Part D: Dabrafenib 75 mg + Trametinib 2 mg | 5.9 | Not reported | 3.7 | 9.0 | Not reported |
| Part D: Dabrafenib 150 mg + Trametinib 2 mg | 14.3 | Not reported | 8.8 | 67.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- 14.8
- value
- 8.2
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 10.1
- group Id
- OG002
- lower Limit
- 3.7
- upper Limit
- 9.0
- value
- 5.9
- group Id
- OG003
- lower Limit
- 8.8
- upper Limit
- 67.8
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 43
- group Id
- OG003
- value
- 39
- units
- Participants
- description
- Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG000
- title
- Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
- id
- OG001
- title
- Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part D: Dabrafenib 75 mg + Trametinib 2 mg
- description
- Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
- id
- OG003
- title
- Part D: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- MEDIAN
- population Description
- ITT Population. Only those participants who had CR or PR were considered.
- reporting Status
- POSTED
- time Frame
- First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 7 years)
- title
- Part D: Duration of Response as Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice