TriangleNCT01871805 · OUTCOME
Percentage of Participants With Disease Control According to RECIST v1.1 by Investigator: Phase II
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
Disease control rate assessed according to RECIST v1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. 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. 95% CI for rate was constructed using Clopper-Pearson method.
Analysis population: Phase II RE population
Groups in this outcome
Alectinib 600 mg (Fed): Phase II
Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
| Group | Source count |
|---|---|
| Alectinib 600 mg (Fed): Phase II | 87 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib 600 mg (Fed): Phase II | 66.7 | Not reported | 55.75 | 76.42 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 55.75
- upper Limit
- 76.42
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 87
- units
- Participants
- description
- Disease control rate assessed according to RECIST v1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. 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. 95% CI for rate was constructed using Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
- id
- OG000
- title
- Alectinib 600 mg (Fed): Phase II
- param Type
- NUMBER
- population Description
- Phase II RE population
- 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 Disease Control According to RECIST v1.1 by Investigator: Phase II
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice