Advanced CholangiocarcinomaNCT04507503
Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
A study testing TAS-120 in people with Advanced Cholangiocarcinoma, run by Taiho Oncology, Inc. at 16 sites in United States.
Trial summary
The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cholangiocarcinoma
- What is being tested?
- TAS-120
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 16 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- >18 years of age.
- Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory.
- Patient has failed standard therapy or standard therapy is not tolerated.
- Has measurable or non-measurable lesion(s).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function.
Who cannot join
- History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.
- History and/or current evidence of clinically significant ectopic mineralization/calcification.
- History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.
- A serious illness or medical condition(s)
- Pregnant or breast-feeding female
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
Banner MD Anderson
Gilbert, Arizona, 85234
Aurora Cancer care
Grafton, Wisconsin, 53024
MD Anderson
Houston, Texas, 77030
University of Kansas Cancer Center
Lee's Summit, Missouri, 64064
Mount Sinai Center of Florida
Miami Beach, Florida, 33140
Advent Health Orlando
Orlando, Florida, 32804
Providence Portland Medical Center
Portland, Oregon, 97213
Utah Cancer Specialists
Salt Lake City, Utah, 84106
University of California, San Francisco (UCSF)
San Francisco, California, 94143
UCLA Division of Hematology-Oncology
Santa Monica, California, 90404
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
Read the detailed description
This is an open-label study to provide expanded access to TAS-120 prior to its commercial availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements who have failed standard therapy or who are unable to tolerate standard therapy.
- Conditions
- Advanced Cholangiocarcinoma
- Being tested
- TAS-120
- Keywords
- Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-120Drug
Also called Futibatinib
Futibatinib 20mg QD orally on a 28 days cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507503
- Sponsor's protocol ID
- TAS-120-401
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
- ClinicalTrials.gov ID
- NCT04507503
- Acronym / sponsor ID
- TAS-120-401
- Conditions
- Advanced Cholangiocarcinoma
- Keywords
- Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- First posted
- 11 Aug 2020 (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 objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
Detailed description
This is an open-label study to provide expanded access to TAS-120 prior to its commercial availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements who have failed standard therapy or who are unable to tolerate standard therapy.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written informed consent.
- >18 years of age.
- Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory.
- Patient has failed standard therapy or standard therapy is not tolerated.
- Has measurable or non-measurable lesion(s).
Key exclusion criteria (5 listed)
- History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.
- History and/or current evidence of clinically significant ectopic mineralization/calcification.
- History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.
- A serious illness or medical condition(s)
- Pregnant or breast-feeding female
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 |
|---|---|---|
| TAS-120Also: FutibatinibFutibatinib 20mg QD orally on a 28 days cycle | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAS-120 in people with Advanced Cholangiocarcinoma, run by Taiho Oncology, Inc. at 16 sites in United States.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 10 Mar 2026.