TriangleNCT02052778 · OUTCOME
Phase 2: Disease Control Rate (DCR)
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
- Up to approximately 37.5 months (through cut-off date 29-May-2021)
What was measured
A DCR was defined as the proportion of participants with objective evidence of CR, PR, or SD, except that there was no requirement for a confirmation of an SD response, if it is maintained for at least 6 weeks post treatment initiation. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes might had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the Baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as a reference the smallest sum diameters while on study. DCR was based on IRC.
Analysis population: Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120.
Groups in this outcome
Phase 2
Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
| Group | Source count |
|---|---|
| Phase 2 | 103 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 | 82.5 | Not reported | 73.8 | 89.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.8
- upper Limit
- 89.3
- value
- 82.5
- denoms
- counts
- group Id
- OG000
- value
- 103
- units
- Participants
- description
- A DCR was defined as the proportion of participants with objective evidence of CR, PR, or SD, except that there was no requirement for a confirmation of an SD response, if it is maintained for at least 6 weeks post treatment initiation. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes might had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of the target lesions, taking as a reference the Baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taken as a reference the smallest sum diameters while on study. DCR was based on IRC.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG000
- title
- Phase 2
- param Type
- NUMBER
- population Description
- Efficacy population included all treated iCCA participants with confirmed FGFR2 gene fusions or other FGFR2 rearrangements who had received at least 1 dose of TAS-120.
- reporting Status
- POSTED
- time Frame
- Up to approximately 37.5 months (through cut-off date 29-May-2021)
- title
- Phase 2: Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice