Biliary Tract CancerNCT06793709
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
An observational study of Biliary Tract Cancer, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
The primary purpose of this study is to investigate the safety of Tasfygo. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Tract Cancer
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 10 Jul 2025to 20 Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with FGFR2 fusion positive unresectable biliary tract cancer with prior chemotherapy who will receive Tasfygo tablet as per daily practice and package insert will be enrolled.
Who may be able to join
- 1. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eisai Inquiry Service contact
About this study
Official title: 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
The primary purpose of this study is to investigate the safety of Tasfygo.
- Conditions
- Biliary Tract Cancer
- Being tested
- No Intervention
- Keywords
- Tasfygo, FGFR2 fusion, Cancer
- Medical subject headings
- Biliary Tract Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Tasfygo tablet 35 milligrams (mg) | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Drug Reactions
Measured: Up to 1 year
Secondary outcomes (1)
Percentage of Participants With Best Overall Response (BOR) Based on Physician's Assessment
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start10 Jul 2025
- Primary completion20 Nov 2032 (estimated)
- Study completion20 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793709
- Sponsor's protocol ID
- E7090-M081-501
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06793709
- Acronym / sponsor ID
- E7090-M081-501
- Conditions
- Biliary Tract Cancer
- Keywords
- Tasfygo, FGFR2 fusion, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 20 Nov 2032 (estimated)
- Study completion
- 20 Nov 2032 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to investigate the safety of Tasfygo.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tasfygo tablet 35 milligrams (mg) | – | Other: No Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with FGFR2 fusion positive unresectable biliary tract cancer with prior chemotherapy who will receive Tasfygo tablet as per daily practice and package insert will be enrolled.
Key inclusion criteria (1 listed)
- 1. Participants with unresectable biliary tract cancer with FGFR2 fusion gene positivity who are naïve to Tasfygo tablet and progressed after chemotherapy.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Tasfygo tablet 35 milligrams (mg) |
Primary outcome
Number of Participants With Adverse Drug Reactions
Time frame: Up to 1 year
1 secondary outcome
Percentage of Participants With Best Overall Response (BOR) Based on Physician's Assessment
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eisai Inquiry Service contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer, run by Eisai Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eisai Inquiry Service (eisai-chiken_hotline@hhc.eisai.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Drug Reactions (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.