TriangleNCT01336634 · OUTCOME
Progression Free Survival (PFS) Based on Local Investigator Assessment
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 study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 113 months
What was measured
Progression Free Survival (PFS) was defined as the time from study treatment start date to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.
Analysis population: All Treated Population (ATP). Only participants with an evaluable PFS events were included in the analysis.
Groups in this outcome
Cohort A (Dabrafenib Monotherapy)
Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD
Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
| Group | Source count |
|---|---|
| Cohort A (Dabrafenib Monotherapy) | 65 |
| Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 48 |
| Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 28 |
| Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Dabrafenib Monotherapy) | 5.4 | Not reported | 2.8 | 6.9 | Not reported |
| Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 10.2 | Not reported | 6.9 | 16.7 | Not reported |
| Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD | 10.8 | Not reported | 7.0 | 14.5 | Not reported |
| Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD | 11.0 | Not reported | 3.0 | 18.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 6.9
- value
- 5.4
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 16.7
- value
- 10.2
- group Id
- OG002
- lower Limit
- 7.0
- upper Limit
- 14.5
- value
- 10.8
- group Id
- OG003
- lower Limit
- 3.0
- upper Limit
- 18.7
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 48
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 18
- units
- Participants
- description
- Progression Free Survival (PFS) was defined as the time from study treatment start date to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
- id
- OG000
- title
- Cohort A (Dabrafenib Monotherapy)
- description
- Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
- id
- OG001
- title
- Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
- description
- Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
- id
- OG002
- title
- Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
- description
- Crossover - Double Combination (Dabrafenib+Trametinib): Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
- id
- OG003
- title
- Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD
- param Type
- MEDIAN
- population Description
- All Treated Population (ATP). Only participants with an evaluable PFS events were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 113 months
- title
- Progression Free Survival (PFS) Based on Local Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice