TriangleNCT03465722 · OUTCOME
Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 24 Months
What was measured
To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib. A complete response (CR) per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response (PR) is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR
Analysis population: Intent-to-Treat Population that included all patients randomized to study.
Groups in this outcome
Avapritinib
300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
Regorafinib
160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
| Group | Source count |
|---|---|
| Avapritinib | 240 |
| Regorafinib | 236 |
Reported measurements
Source class 1
Responder
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avapritinib | 41 | Not reported | Not reported | Not reported | Not reported |
| Regorafinib | 17 | Not reported | Not reported | Not reported | Not reported |
Non-Responder
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avapritinib | 199 | Not reported | Not reported | Not reported | Not reported |
| Regorafinib | 219 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 17
- title
- Responder
- measurements
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 219
- title
- Non-Responder
- denoms
- counts
- group Id
- OG000
- value
- 240
- group Id
- OG001
- value
- 236
- units
- Participants
- description
- To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib. A complete response (CR) per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response (PR) is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR
- groups
- description
- 300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
- id
- OG000
- title
- Avapritinib
- description
- 160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
- id
- OG001
- title
- Regorafinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intent-to-Treat Population that included all patients randomized to study.
- reporting Status
- POSTED
- time Frame
- 24 Months
- title
- Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice