NCT06506955

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

An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	futibatinib	TAS-120 futibatinib monotherapy
DRUG	futibatinib, fulvestrant	TAS-120 futibatinib combination therapy with fulvestrant

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-04-01
• Completion: 2027-04-30
• First posted: 2024-07-18
• Last updated: 2026-04-03

Locations

9 sites across 5 countries: United States, France, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study