TriangleNCT03673501 · OUTCOME
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
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 confirmed CR or PR to disease progression (up to 1.74 years)
What was measured
ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Analysis population: The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Groups in this outcome
Ripretinib
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
| Group | Source count |
|---|---|
| Ripretinib | 163 |
| Sunitinib | 164 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ripretinib | 23.9 | Not reported | 17.6 | 31.2 | Not reported |
| Sunitinib | 14.6 | Not reported | 9.6 | 21.0 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0333
- statistical Comment
- Strata: intolerance to imatinib treatment
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0333
- statistical Comment
- Strata: intolerance to imatinib treatment
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.6
- upper Limit
- 31.2
- value
- 23.9
- group Id
- OG001
- lower Limit
- 9.6
- upper Limit
- 21.0
- value
- 14.6
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 164
- units
- Participants
- description
- ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
- id
- OG000
- title
- Ripretinib
- description
- Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
- id
- OG001
- title
- Sunitinib
- param Type
- NUMBER
- population Description
- The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
- reporting Status
- POSTED
- time Frame
- From confirmed CR or PR to disease progression (up to 1.74 years)
- title
- Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice