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

NCT06506955 · tracked via the Priya Life Science UK tracker

Sponsor

Taiho Oncology, Inc.

Phase

Phase 2/3

Started

2024-10-01

Last updated

2026-07-28

Condition(s) studied

Advanced/Metastatic Cancer

Investigational drug(s) / intervention(s)

futibatinibfutibatinib, fulvestrant

futibatinib: TAS-120 futibatinib monotherapy

futibatinib, fulvestrant: TAS-120 futibatinib combination therapy with fulvestrant

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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. — 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

Trial sites (9)

Facility	City	Region
University of California, San Francisco (UCSF)	San Francisco	California
Institut Paoli-Calmettes	Marseille	France
Institut De Cancerologie Strasbourg	Strasbourg	France
Severance Hospital	Seoul	South Korea
Hospital Universitari, Vall d'Hebron	Barcelona	Spain
Centro Integral Oncologico	Madrid	Spain
Royal Marsden NHS Foundation Trust	London	United Kingdom
Sarah Cannon Research Institute UK	London	United Kingdom
University College London Hospitals NHS Foundation Trust	London	United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06506955 on ClinicalTrials.gov ↗ ← All trials in the UK