TriangleNCT02737501 · OUTCOME
Confirmed Intracranial ORR (iORR)
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
- Baseline up to end of treatment (Up to 36 months)
What was measured
ORR was defined as percentage of participants who achieved CR or PR in the central nervous system (CNS) in randomized participants with intracranial CNS metastasis at baseline. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.
Analysis population: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
Groups in this outcome
Randomized Phase: Brigatinib 90 mg QD/180 QD
Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
Randomized Phase: Crizotinib 250 mg BID
Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
Crossover Phase: Brigatinib 90 mg QD/180 mg QD
Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
| Group | Source count |
|---|---|
| Randomized Phase: Brigatinib 90 mg QD/180 QD | 47 |
| Randomized Phase: Crizotinib 250 mg BID | 49 |
| Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomized Phase: Brigatinib 90 mg QD/180 QD | 66.0 | Not reported | 50.69 | 79.14 | Not reported |
| Randomized Phase: Crizotinib 250 mg BID | 14.3 | Not reported | 5.94 | 27.24 | Not reported |
| Crossover Phase: Brigatinib 90 mg QD/180 mg QD | 35.7 | Not reported | 21.55 | 51.97 | Not reported |
Source statistical analyses
- ci Lower Limit
- 4.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 39.11
- estimate Comment
- Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of prior chemotherapy for Locally advanced or metastatic disease at study entry (current strata).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 13.56
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 4.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 39.11
- estimate Comment
- Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of prior chemotherapy for Locally advanced or metastatic disease at study entry (current strata).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 13.56
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.69
- upper Limit
- 79.14
- value
- 66.0
- group Id
- OG001
- lower Limit
- 5.94
- upper Limit
- 27.24
- value
- 14.3
- group Id
- OG002
- lower Limit
- 21.55
- upper Limit
- 51.97
- value
- 35.7
- denoms
- counts
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 42
- units
- Participants
- description
- ORR was defined as percentage of participants who achieved CR or PR in the central nervous system (CNS) in randomized participants with intracranial CNS metastasis at baseline. CR is defined as disappearance of all extranodal target and non-target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis for target lesions and all lymph nodes must be non-pathological in size (\<10 mm short axis), normalization of tumor marker level for non-target lesions. PR is at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
- id
- OG000
- title
- Randomized Phase: Brigatinib 90 mg QD/180 QD
- description
- Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
- id
- OG001
- title
- Randomized Phase: Crizotinib 250 mg BID
- description
- Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
- id
- OG002
- title
- Crossover Phase: Brigatinib 90 mg QD/180 mg QD
- param Type
- NUMBER
- population Description
- ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment (Up to 36 months)
- title
- Confirmed Intracranial ORR (iORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice