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New hope for bile duct cancer patients: expanded access to targeted drug futibatinib

NCT ID NCT04507503

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved This study
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program provides futibatinib (TAS-120) to adults with advanced bile duct cancer that has a specific FGFR2 gene change and who have no other treatment options. Participants take one 20 mg pill daily. The goal is to give access to this drug while it is being studied further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Futibatinib (TAS-120)
What this could lead to
If it works, this could offer a treatment option for people with advanced bile duct cancer who have a specific gene change and have run out of standard therapies.
What could go wrong
This is an expanded access program, not a formal trial, so it provides access rather than proving effectiveness. The drug may not work for everyone and can have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provide written informed consent. 2. \>18 years of age. 3. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory. 4. Patient has failed standard therapy or standard therapy is not tolerated. 5. Has measurable or non-measurable lesion(s). 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Adequate organ function. Exclusion Criteria: 1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis. 2. History and/or current evidence of clinically significant ectopic mineralization/calcification. 3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination. 4. A serious illness or medical condition(s) 5. Pregnant or breast-feeding female

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cholangiocarcinoma

Contacts and locations

Locations

  • Advent Health Orlando

    Orlando, Florida, 32804, United States

  • Aurora Cancer care

    Grafton, Wisconsin, 53024, United States

  • Banner MD Anderson

    Gilbert, Arizona, 85234, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mount Sinai Center of Florida

    Miami Beach, Florida, 33140, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231, United States

  • UCLA Division of Hematology-Oncology

    Santa Monica, California, 90404, United States

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94143, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Kansas Cancer Center

    Lee's Summit, Missouri, 64064, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

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