TriangleNCT01871805 · OUTCOME
Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I
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
- Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
What was measured
Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
Analysis population: Phase I RE population comprised all Phase I participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.
Groups in this outcome
Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
Alectinib Other Than 600 mg (Fasted/Fed): Phase I
Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 760, or 900 mg on Cycle 1 Day -3 and then received 300, 460, 760, or 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
| Group | Source count |
|---|---|
| Alectinib 600 mg (Fed): Phase I (20/40/150 mg) | 13 |
| Alectinib Other Than 600 mg (Fasted/Fed): Phase I | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib 600 mg (Fed): Phase I (20/40/150 mg) | 69.2 | Not reported | 38.57 | 90.91 | Not reported |
| Alectinib Other Than 600 mg (Fasted/Fed): Phase I | 55.9 | Not reported | 37.89 | 72.81 | Not reported |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0251
- p Value Comment
- Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
- statistical Method
- Exact Clopper-Pearson CI, 2 sided
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0203
- p Value Comment
- Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
- statistical Method
- Exact Clopper-Pearson CI, 2 sided
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0251
- p Value Comment
- Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
- statistical Method
- Exact Clopper-Pearson CI, 2 sided
- group Ids
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0203
- p Value Comment
- Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.
- statistical Method
- Exact Clopper-Pearson CI, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.57
- upper Limit
- 90.91
- value
- 69.2
- group Id
- OG001
- lower Limit
- 37.89
- upper Limit
- 72.81
- value
- 55.9
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG000
- title
- Alectinib 600 mg (Fed): Phase I (20/40/150 mg)
- description
- Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 240, 300, 460, 760, or 900 mg on Cycle 1 Day -3 and then received 300, 460, 760, or 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG001
- title
- Alectinib Other Than 600 mg (Fasted/Fed): Phase I
- param Type
- NUMBER
- population Description
- Phase I RE population comprised all Phase I participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.
- reporting Status
- POSTED
- time Frame
- Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)
- title
- Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice