TriangleNCT02052778 · OUTCOME
Phase 1: Dose Expansion: Progression-free Survival (PFS)
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
- up to approximately 27.5 months (through cut-off date 30-Jun-2019)
What was measured
A PFS was defined as the time (in months) from the day of the first dose to the date of first documented disease progression or death (due to any cause), whichever occurred first. Participants who died without a reported disease progression were considered to have progressed on the date of their death, participants who did not progress or die were censored on the date of their last tumor assessment, participants who had no on-study assessments and did not die were censored on the first dosing date, and participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. PFS assessment per protocol was by IRC assessment for Cohorts 1 to 6 and for pooled Sub-cohort: PFS 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 | 4.1 | Not reported | 2.7 | 6.9 | Not reported |
| Phase 1: Dose Expansion: Cohort 2 | 1.9 | Not reported | 1.3 | 4.9 | Not reported |
| Phase 1: Dose Expansion: Cohort 3 | 1.8 | Not reported | 1.3 | 4.7 | Not reported |
| Phase 1: Dose Expansion: Cohort 4 | 1.3 | Not reported | 0.9 | 4.1 | Not reported |
| Phase 1: Dose Expansion: Cohort 5 | 3.5 | Not reported | 1.7 | 6.8 | Not reported |
| Phase 1: Dose Expansion: Cohort 6 | 2.7 | Not reported | 1.4 | 2.7 | Not reported |
| Phase 1: Dose Expansion: Pooled Sub-cohort | 6.9 | Not reported | 4.6 | 10.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.7
- upper Limit
- 6.9
- value
- 4.1
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- 4.9
- value
- 1.9
- group Id
- OG002
- lower Limit
- 1.3
- upper Limit
- 4.7
- value
- 1.8
- group Id
- OG003
- lower Limit
- 0.9
- upper Limit
- 4.1
- value
- 1.3
- group Id
- OG004
- lower Limit
- 1.7
- upper Limit
- 6.8
- value
- 3.5
- group Id
- OG005
- lower Limit
- 1.4
- upper Limit
- 2.7
- value
- 2.7
- group Id
- OG006
- lower Limit
- 4.6
- upper Limit
- 10.8
- value
- 6.9
- 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 PFS was defined as the time (in months) from the day of the first dose to the date of first documented disease progression or death (due to any cause), whichever occurred first. Participants who died without a reported disease progression were considered to have progressed on the date of their death, participants who did not progress or die were censored on the date of their last tumor assessment, participants who had no on-study assessments and did not die were censored on the first dosing date, and participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. PFS assessment per protocol was by IRC assessment for Cohorts 1 to 6 and for pooled Sub-cohort: PFS 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
- MEDIAN
- 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 27.5 months (through cut-off date 30-Jun-2019)
- title
- Phase 1: Dose Expansion: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice