Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Taiho Oncology, Inc.
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing futibatinib, an oral medication, in patients with specific genetic changes in their cancer. It aims to block proteins that help cancer grow, targeting those who may not respond well to typical treatments. Futibatinib has shown selective antitumor activity in various tumors.
Eligibility Criteria
This trial is for adults with advanced solid tumors, gastric or gastro-esophageal junction cancer, and certain blood cancers that have specific FGFR genetic changes. Participants must have measurable disease and should have tried standard treatments without success. They can't join if they've had prior FGFR inhibitor treatment or significant eye, mineral balance disorders, or unstable brain metastases.Inclusion Criteria
I have had at least 2 treatments for my advanced cancer.
My stomach or GEJ cancer worsened after the last treatment.
My cancer has returned or worsened after standard treatment.
My cancer is a type of blood cancer with a specific genetic change.
I am fully active or restricted in physically strenuous activity but can do light work.
My cancer is advanced or has spread, and tests show FGFR1-4 changes.
My cancer in the stomach or gastroesophageal junction is advanced and has a specific genetic feature (FGFR2 amplification).
Exclusion Criteria
I have been treated with an FGFR inhibitor before.
Participant Groups
The study tests the drug Futibatinib's effectiveness and safety in three groups: those with solid tumors (excluding primary brain tumors) having FGFR1-4 rearrangements; those with gastric cancer with FGFR2 amplification; and blood cancers with FGFR1 rearrangements.
3Treatment groups
Experimental Treatment
Group I: Futibatinib (Cohort C)Experimental Treatment1 Intervention
Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement
Group II: Futibatinib (Cohort B)Experimental Treatment1 Intervention
Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification
Group III: Futibatinib (Cohort A)Experimental Treatment1 Intervention
Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements
Futibatinib is already approved in United States for the following indications:
🇺🇸 Approved in United States as Lytgobi for:
- Treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Wisconsin Cancer CenterMadison, WI
Mary Crowley Cancer Research CentersDallas, TX
MultiCare Health System Institute for Research and InnovationAuburn, WA
University of Iowa Hospital and ClinicsIowa City, IA
More Trial Locations
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Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor