TriangleNCT02052778 · OUTCOME
Phase 1: Dose Expansion: 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 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohort
What was measured
A DCR was defined as the proportion of participants with objective evidence of CR, PR, or stable disease (SD), except that there was no requirement for a confirmation of an SD, 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. For Cohorts 1 to 6: DCR was based on IRC and for pooled Sub-cohort: DCR was based on investigator review.
Analysis population: Efficacy population included all participants who had received at least 1 dose of TAS-120. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1 and 2.
Groups in this outcome
Phase 1: Dose Expansion Cohort 1
Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors 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.
Phase 1: Dose Expansion: Cohort 2
Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations 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.
Phase 1: Dose Expansion: Cohort 3
Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations 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.
Phase 1: Dose Expansion: Cohort 4
Participants with breast or gastric cancer with harboring FGFR2 amplification 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.
Phase 1: Dose Expansion: Cohort 5
Participants with tumor types harboring FGFR gene fusions or activating mutations 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.
Phase 1: Dose Expansion: Cohort 6
Participants who were not included in Cohorts 1 to 5 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.
Phase 1: Dose Expansion: Pooled Sub-cohort
Participants with iCCA and other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 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 1: Dose Expansion Cohort 1 | 57 |
| Phase 1: Dose Expansion: Cohort 2 | 34 |
| Phase 1: Dose Expansion: Cohort 3 | 15 |
| Phase 1: Dose Expansion: Cohort 4 | 13 |
| Phase 1: Dose Expansion: Cohort 5 | 24 |
| Phase 1: Dose Expansion: Cohort 6 | 27 |
| Phase 1: Dose Expansion: Pooled Sub-cohort | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Dose Expansion Cohort 1 | 66.7 | Not reported | 52.9 | 78.6 | Not reported |
| Phase 1: Dose Expansion: Cohort 2 | 23.5 | Not reported | 10.7 | 41.2 | Not reported |
| Phase 1: Dose Expansion: Cohort 3 | 33.3 | Not reported | 11.8 | 61.6 | Not reported |
| Phase 1: Dose Expansion: Cohort 4 | 38.5 | Not reported | 13.9 | 68.4 | Not reported |
| Phase 1: Dose Expansion: Cohort 5 | 54.2 | Not reported | 32.8 | 74.4 | Not reported |
| Phase 1: Dose Expansion: Cohort 6 | 22.2 | Not reported | 8.6 | 42.3 | Not reported |
| Phase 1: Dose Expansion: Pooled Sub-cohort | 66.7 | Not reported | 46.0 | 83.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52.9
- upper Limit
- 78.6
- value
- 66.7
- group Id
- OG001
- lower Limit
- 10.7
- upper Limit
- 41.2
- value
- 23.5
- group Id
- OG002
- lower Limit
- 11.8
- upper Limit
- 61.6
- value
- 33.3
- group Id
- OG003
- lower Limit
- 13.9
- upper Limit
- 68.4
- value
- 38.5
- group Id
- OG004
- lower Limit
- 32.8
- upper Limit
- 74.4
- value
- 54.2
- group Id
- OG005
- lower Limit
- 8.6
- upper Limit
- 42.3
- value
- 22.2
- group Id
- OG006
- lower Limit
- 46.0
- upper Limit
- 83.5
- value
- 66.7
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 27
- group Id
- OG006
- value
- 27
- units
- Participants
- description
- A DCR was defined as the proportion of participants with objective evidence of CR, PR, or stable disease (SD), except that there was no requirement for a confirmation of an SD, 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. For Cohorts 1 to 6: DCR was based on IRC and for pooled Sub-cohort: DCR was based on investigator review.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors 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 1: Dose Expansion Cohort 1
- description
- Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations 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
- OG001
- title
- Phase 1: Dose Expansion: Cohort 2
- description
- Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations 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
- OG002
- title
- Phase 1: Dose Expansion: Cohort 3
- description
- Participants with breast or gastric cancer with harboring FGFR2 amplification 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
- OG003
- title
- Phase 1: Dose Expansion: Cohort 4
- description
- Participants with tumor types harboring FGFR gene fusions or activating mutations 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
- OG004
- title
- Phase 1: Dose Expansion: Cohort 5
- description
- Participants who were not included in Cohorts 1 to 5 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
- OG005
- title
- Phase 1: Dose Expansion: Cohort 6
- description
- Participants with iCCA and other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
- id
- OG006
- title
- Phase 1: Dose Expansion: Pooled Sub-cohort
- param Type
- NUMBER
- population Description
- Efficacy population included all participants who had received at least 1 dose of TAS-120. Data was planned to be collected and analyzed on pooled population of participants who received 16 mg of TAS-120 in the sub-cohorts 1 and 2.
- reporting Status
- POSTED
- time Frame
- Up to approximately 50.5 months (through cut-off date 29-May-2021) for Cohorts 1 to 6; up to approximately 27.5 months (through cut-off date 30-Jun-2019) for pooled sub-cohort
- title
- Phase 1: Dose Expansion: Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice