TriangleNCT02052778 · OUTCOME
Phase 1: Dose Expansion: Number of Participants With Any Adverse Events (AEs) and Any Serious AEs (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose up to approximately 50.5 months (through cut-off date 29-May-2021)
What was measured
An AE was defined as any untoward medical condition that occurred in a participant from the time the informed consent form (ICF) was signed and does not necessarily had a causal relationship with the use of the product. An SAE was an AE that falls into one or more of the following categories: a. resulted in death, b. was life threatening, c. required inpatient hospitalization or prolongation of existing hospitalization, d. resulted in persistent or significant disability or incapacity, e. was a congenital anomaly/birth defect, f. other important medical event.
Analysis population: Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120.
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: Sub-cohort 1
Participants with iCCA 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.
Phase 1: Dose Expansion: Sub-cohort 2
Participants with 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: Sub-cohort 1 | 19 |
| Phase 1: Dose Expansion: Sub-cohort 2 | 8 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Dose Expansion Cohort 1 | 57 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 2 | 34 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 3 | 15 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 4 | 13 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 5 | 23 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 6 | 26 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Sub-cohort 1 | 18 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Sub-cohort 2 | 5 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Dose Expansion Cohort 1 | 27 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 2 | 13 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 3 | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 4 | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 5 | 13 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Cohort 6 | 14 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Sub-cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Dose Expansion: Sub-cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 26
- group Id
- OG006
- value
- 18
- group Id
- OG007
- value
- 5
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- SAEs
- 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
- 19
- group Id
- OG007
- value
- 8
- units
- Participants
- description
- An AE was defined as any untoward medical condition that occurred in a participant from the time the informed consent form (ICF) was signed and does not necessarily had a causal relationship with the use of the product. An SAE was an AE that falls into one or more of the following categories: a. resulted in death, b. was life threatening, c. required inpatient hospitalization or prolongation of existing hospitalization, d. resulted in persistent or significant disability or incapacity, e. was a congenital anomaly/birth defect, f. other important medical event.
- 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 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: Sub-cohort 1
- description
- Participants with 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
- OG007
- title
- Phase 1: Dose Expansion: Sub-cohort 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120.
- reporting Status
- POSTED
- time Frame
- From the first dose up to approximately 50.5 months (through cut-off date 29-May-2021)
- title
- Phase 1: Dose Expansion: Number of Participants With Any Adverse Events (AEs) and Any Serious AEs (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice