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

NCT06506955 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: TAS120-404
• Study Type: interventional
• Target: 15
• Locations: 5 countries
• Sites: 9

Brief 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.

Conditions

Advanced/Metastatic Cancer

Keywords

Futibatinib; TAS-120; FGFR; Cholangiocarcinoma; Breast cance; Urothelial Carcinom

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 5 years

Study Arms (2)

TAS-120 (futibatinib) monotherapy

EXPERIMENTAL

TAS-120 tablets, oral, cycle length is defined as per antecedent study design

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

Drug: futibatinib, fulvestrant

Interventions

futibatinib DRUG

TAS-120 futibatinib monotherapy

Also known as: TAS-120

TAS-120 (futibatinib) monotherapy

futibatinib, fulvestrant DRUG

TAS-120 futibatinib combination therapy with fulvestrant

Also known as: TAS-120 + fulvestrant

TAS-120 (futibatinib) combination therapy with fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (9)

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Institut De Cancerologie Strasbourg

Strasbourg, 67033, France

Location

Severance Hospital

Seoul, 3722, South Korea

Location

Hospital Universitari, Vall d'Hebron

Barcelona, 8035, Spain

Location

Centro Integral Oncologico

Madrid, 28050, Spain

Location

Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, W1T 7HA, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Cholangiocarcinoma

Interventions

futibatinib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 18, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); GB (3); US (1); KR (1); ES (2)