Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.

May 27, 2026 updated by: Taiho Oncology, Inc.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Strasbourg, France, 67033
        • Institut De Cancerologie Strasbourg
  • South Korea
      • Seoul, South Korea, 3722
        • Severance Hospital
  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitari, Vall d'Hebron
      • Madrid, Spain, 28050
        • Centro Integral Oncologico
  • United Kingdom
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Foundation Trust
      • London, United Kingdom, W1T 7HA
        • University College London Hospitals NHS Foundation Trust
  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco (UCSF)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

• Has met any discontinuation criteria within the antecedent futibatinib study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAS-120 (futibatinib) monotherapy
TAS-120 tablets, oral, cycle length is defined as per antecedent study design
Drug: futibatinib
TAS-120 futibatinib monotherapy
Other Names:
  • TAS-120
Experimental: TAS-120 (futibatinib) combination therapy with fulvestrant
TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design
Drug: futibatinib, fulvestrant
TAS-120 futibatinib combination therapy with fulvestrant
Other Names:
  • TAS-120 + fulvestrant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAS120-404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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