TriangleNCT02034110 · OUTCOME
Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
What was measured
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Analysis population: ITT/Evaluable population - Primary and expansion cohort combined
Groups in this outcome
Adenocarcinoma of the Small Intestine (ASI)
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 |
|---|---|
| Adenocarcinoma of the Small Intestine (ASI) | 3 |
Reported measurements
Investigator assessment @ up to 78 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adenocarcinoma of the Small Intestine (ASI) | 67 | Not reported | 9.4 | 99.2 | Not reported |
Investigator assessment @ up to 92 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Adenocarcinoma of the Small Intestine (ASI) | 67 | Not reported | 9.4 | 99.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 67
- title
- Investigator assessment @ up to 78 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.4
- upper Limit
- 99.2
- value
- 67
- title
- Investigator assessment @ up to 92 months
- denoms
- counts
- group Id
- OG000
- value
- 3
- units
- Participants
- description
- Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- 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
- Adenocarcinoma of the Small Intestine (ASI)
- param Type
- NUMBER
- population Description
- ITT/Evaluable population - Primary and expansion cohort combined
- reporting Status
- POSTED
- time Frame
- From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
- title
- Overall Response Rate (ORR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice