NCT02052778

A Study of TAS-120 in Patients With Advanced Solid Tumors

Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts: 1. Dose escalation portion to determine the -Maximum Tolerated Dose and/ or Recommended Phase 2 Dose of futibatinib. 2. Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary central nervous system tumors, urothelial carcinoma, breast cancer, gastric cancer. 3. Phase 2 study portion to confirm objective response rate of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

Conditions

• Cholangiocarcinoma
• Urothelial Cancer
• Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors
• Primary CNS Tumors
• Breast Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Futibatinib	oral once daily dosing, 21-day cycle

Timeline

• Start date: 2014-07-21
• Primary completion: 2020-10-01
• Completion: 2024-10-22
• First posted: 2014-02-03
• Last updated: 2025-03-27
• Results posted: 2024-03-20

Locations

58 sites across 13 countries: United States, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study