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Clinical Trials in South Korea / NCT06506955
Active, not recruiting Phase 2/3

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

NCT06506955 · tracked via the Priya Life Science South Korea 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)

futibatinib →futibatinib, 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
No
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)

FacilityCityRegionStatus
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

More Taiho Oncology, Inc. trials in South Korea

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. Recruiting
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement Recruiting
A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection Active, not recruiting
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) Active, not recruiting
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 South Korea