TriangleNCT01072175 · OUTCOME
Part B: Progression-free Survival (PFS) as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma
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 date of first dose to the earliest date of disease progression (PD) or death due to any cause (up to approximately 8 years)
What was measured
PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. 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. BRAFi-naïve were the participants with BRAF-mutation positive melanoma who had not received prior therapy with a BRAF-inhibitor..
Analysis population: All Treated Population.
Groups in this outcome
Part B: Dabrafenib 75 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
Part B: Dabrafenib 150 mg + Trametinib 2 mg
Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
| Group | Source count |
|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 6 |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 22 |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 25 |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Dabrafenib 75 mg + Trametinib 1 mg | 8.7 | Not reported | 3.4 | NA | NA: Not estimable due to insufficient number of participants with events |
| Part B: Dabrafenib 150 mg + Trametinib 1 mg | 8.2 | Not reported | 4.3 | 11.0 | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 1.5 mg | 5.4 | Not reported | 3.5 | 12.8 | Not reported |
| Part B: Dabrafenib 150 mg + Trametinib 2 mg | 10.8 | Not reported | 3.6 | 18.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 3.4
- upper Limit
- NA
- value
- 8.7
- group Id
- OG001
- lower Limit
- 4.3
- upper Limit
- 11.0
- value
- 8.2
- group Id
- OG002
- lower Limit
- 3.5
- upper Limit
- 12.8
- value
- 5.4
- group Id
- OG003
- lower Limit
- 3.6
- upper Limit
- 18.6
- value
- 10.8
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 24
- units
- Participants
- description
- PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. 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. BRAFi-naïve were the participants with BRAF-mutation positive melanoma who had not received prior therapy with a BRAF-inhibitor..
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
- id
- OG000
- title
- Part B: Dabrafenib 75 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG001
- title
- Part B: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
- id
- OG002
- title
- Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
- description
- Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
- id
- OG003
- title
- Part B: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- MEDIAN
- population Description
- All Treated Population.
- reporting Status
- POSTED
- time Frame
- From the date of first dose to the earliest date of disease progression (PD) or death due to any cause (up to approximately 8 years)
- title
- Part B: Progression-free Survival (PFS) as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice