TriangleNCT02034110 · OUTCOME
Duration of Response (DoR) 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 first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
What was measured
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
Analysis population: ITT/Evaluable population - Primary and expansion cohorts combined. Only responders were included in the analysis.
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) | 23 |
Reported measurements
Investigator assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Cancer (BTC) | 38.9 | Not reported | 24.3 | 59.4 | Not reported |
Independent radiology review
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Biliary Tract Cancer (BTC) | 45.4 | Not reported | 20.1 | 64.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.3
- upper Limit
- 59.4
- value
- 38.9
- title
- Investigator assessment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.1
- upper Limit
- 64.9
- value
- 45.4
- title
- Independent radiology review
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
- 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 cohorts combined. Only responders were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
- title
- Duration of Response (DoR) 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