Advanced/Metastatic CancerPhase 2/3NCT06506955
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
A Phase 2/3 study testing futibatinib and futibatinib, fulvestrant in people with Advanced/Metastatic Cancer, run by Taiho Oncology, Inc. at 9 sites in 5 countries.
Trial summary
This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Cancer
- What is being tested?
- futibatinib and futibatinib, fulvestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 1 Oct 2024to 30 Apr 2027
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
- Ability to take medications orally (PO) (feeding tube is not permitted).
Who cannot join
- Has met any discontinuation criteria within the antecedent futibatinib study.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United Kingdom3 sites
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Sarah Cannon Research Institute UK
London, W1G 6AD
University College London Hospitals NHS Foundation Trust
London, W1T 7HA
France2 sites
Institut Paoli-Calmettes
Marseille, 13009
Institut De Cancerologie Strasbourg
Strasbourg, 67033
Spain2 sites
Hospital Universitari, Vall d'Hebron
Barcelona, 8035
Centro Integral Oncologico
Madrid, 28050
United States1 site
University of California, San Francisco (UCSF)
San Francisco, California, 94143
About this study
Official title: An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
Read the detailed description
TAS-120-404 is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
Patients who are still receiving futibatinib as monotherapy or as combination therapy, are deriving clinical benefit with no undue risk as assessed by the investigator, and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate.
- Conditions
- Advanced/Metastatic Cancer
- Being tested
- futibatinib, futibatinib, fulvestrant
- Keywords
- Futibatinib, TAS-120, FGFR, Cholangiocarcinoma, Breast cance, Urothelial Carcinom
- Medical subject headings
- Neoplasm Metastasis, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
futibatinibDrug
Also called TAS-120
TAS-120 futibatinib monotherapy
futibatinib, fulvestrantDrug
Also called TAS-120 + fulvestrant
TAS-120 futibatinib combination therapy with fulvestrant
| Study group | Role | What they receive |
|---|---|---|
| TAS-120 (futibatinib) monotherapy | Experimental | TAS-120 tablets, oral, cycle length is defined as per antecedent study design Receives: Drug: futibatinib |
| TAS-120 (futibatinib) combination therapy with fulvestrant | Experimental | TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design Receives: Drug: futibatinib, fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0.
To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Oct 2024
- Primary completionApr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic CancerStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506955
- Sponsor's protocol ID
- TAS120-404
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
- ClinicalTrials.gov ID
- NCT06506955
- Acronym / sponsor ID
- TAS120-404
- Conditions
- Advanced/Metastatic Cancer
- Keywords
- Futibatinib, TAS-120, FGFR, Cholangiocarcinoma, Breast cance, Urothelial Carcinom
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Jul 2024 (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.
This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
Detailed description
TAS-120-404 is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
Patients who are still receiving futibatinib as monotherapy or as combination therapy, are deriving clinical benefit with no undue risk as assessed by the investigator, and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-120 (futibatinib) monotherapy | Experimental | Drug: futibatinibTAS-120 tablets, oral, cycle length is defined as per antecedent study design |
| TAS-120 (futibatinib) combination therapy with fulvestrant | Experimental | Drug: futibatinib, fulvestrantTAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written informed consent.
- Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
- Ability to take medications orally (PO) (feeding tube is not permitted).
Key exclusion criteria (1 listed)
- Has met any discontinuation criteria within the antecedent futibatinib study.
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 |
|---|---|---|
| futibatinibAlso: TAS-120TAS-120 futibatinib monotherapy | Drug | TAS-120 (futibatinib) monotherapy |
| futibatinib, fulvestrantAlso: TAS-120 + fulvestrantTAS-120 futibatinib combination therapy with fulvestrant | Drug | TAS-120 (futibatinib) combination therapy with fulvestrant |
Primary outcome
Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0.
Time frame: through study completion, an average of 5 years
To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk
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 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing futibatinib and futibatinib, fulvestrant in people with Advanced/Metastatic Cancer, run by Taiho Oncology, Inc. at 9 sites in 5 countries.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, France, Spain, United States, South Korea. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0. (time frame: through study completion, an average of 5 years). 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 28 Jul 2026.