TriangleNCT01871805 · OUTCOME
Duration of Response (DOR) 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
- MEDIAN
- Unit
- months
- 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
DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (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. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley 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. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
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) | 9 |
| Alectinib Other Than 600 mg (Fasted/Fed): Phase I | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib 600 mg (Fed): Phase I (20/40/150 mg) | 12.2 | Not reported | 4.9 | 20.9 | Not reported |
| Alectinib Other Than 600 mg (Fasted/Fed): Phase I | 11.0 | Not reported | 6.3 | 14.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.9
- upper Limit
- 20.9
- value
- 12.2
- group Id
- OG001
- lower Limit
- 6.3
- upper Limit
- 14.8
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (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. Refer "Outcome Measure 2" for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley 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
- MEDIAN
- population Description
- Phase I RE population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.
- 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
- Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice