TriangleNCT02034110 · OUTCOME
Progression Free Survival (PFS) in the Biliary Tract Cancer (BTC) Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- 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 92 months (cut-off date for end of study = 10-Dec-21)
What was measured
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as 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.
Analysis population: ITT/Evaluable population - Primary and expansion cohort combined
Groups in this outcome
Biliary Tract Cancer (BTC)
All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
| Group | Source count |
|---|---|
| Biliary Tract Cancer (BTC) | 43 |
Reported measurements
Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Cancer (BTC) | 39.0 | Not reported | 24.1 | 41.0 | Not reported |
Independent radiology review
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Cancer (BTC) | 32.6 | Not reported | 23.6 | 56.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.1
- upper Limit
- 41.0
- value
- 39.0
- title
- Investigator assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.6
- upper Limit
- 56.0
- value
- 32.6
- title
- Independent radiology review
- denoms
- counts
- group Id
- OG000
- value
- 43
- units
- Participants
- description
- Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
- id
- OG000
- title
- Biliary Tract Cancer (BTC)
- param Type
- MEDIAN
- population Description
- ITT/Evaluable population - Primary and expansion cohort combined
- 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 92 months (cut-off date for end of study = 10-Dec-21)
- title
- Progression Free Survival (PFS) in the Biliary Tract Cancer (BTC) Cohort
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice