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A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene Positivity Who Progressed After Chemotherapy

Post-marketing Observational Study of Tasfygo Tablet 35 mg to Evaluate the Safety of Tasfygo in Patients With Unresectable Biliary Tract Cancer With FGFR2 Fusion Gene Positivity Who Progressed After Chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06793709
Enrollment
60
Registered
2025-01-27
Start date
2025-07-10
Completion date
2032-11-20
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Cancer

Keywords

Tasfygo, FGFR2 fusion, Cancer

Brief summary

The primary purpose of this study is to investigate the safety of Tasfygo.

Interventions

OTHERNo Intervention

This is a non-interventional study.

Sponsors

Eisai Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1\. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.

Exclusion criteria

Not applicable.

Design outcomes

Primary

MeasureTime frame
Number of Participants With Adverse Drug ReactionsUp to 1 year

Secondary

MeasureTime frame
Percentage of Participants With Best Overall Response (BOR) Based on Physician's AssessmentUp to 1 year

Countries

Japan

Contacts

CONTACTEisai Inquiry Service
eisai-chiken_hotline@hhc.eisai.co.jp

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026