TriangleNCT03372057 · OUTCOME
Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
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
- 56 days (2 cycles; 28-day cycles)
What was measured
ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
Analysis population: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
Groups in this outcome
Dose Optimization Phase: Cohort 1
Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
Dose Optimization Phase: Cohort 2
Duvelisib 75 mg PO BID, administered in 28-day cycles.
| Group | Source count |
|---|---|
| Dose Optimization Phase: Cohort 1 | 13 |
| Dose Optimization Phase: Cohort 2 | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Optimization Phase: Cohort 1 | 53.8 | Not reported | 26.7 | 80.9 | Not reported |
| Dose Optimization Phase: Cohort 2 | 53.8 | Not reported | 26.7 | 80.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.7
- upper Limit
- 80.9
- value
- 53.8
- group Id
- OG001
- lower Limit
- 26.7
- upper Limit
- 80.9
- value
- 53.8
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- ORR was defined as the percentage of participants with CR + PR, as assessed by the investigator using the Lugano criteria, for participants receiving the optimal dose of duvelisib for at least one cycle of study therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
- id
- OG000
- title
- Dose Optimization Phase: Cohort 1
- description
- Duvelisib 75 mg PO BID, administered in 28-day cycles.
- id
- OG001
- title
- Dose Optimization Phase: Cohort 2
- param Type
- NUMBER
- population Description
- Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. As pre-specified, efficacy analysis using investigator assessment reported for the Dose Optimization Phase only.
- reporting Status
- POSTED
- time Frame
- 56 days (2 cycles; 28-day cycles)
- title
- Overall Response Rate (ORR) as Assessed by the Investigator Using the Lugano Criteria
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice