NCT04233567

Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

A Phase II Study of Oral Infigratinib in Adult Patients With Advanced or Metastatic Solid Tumors With FGFR1-3 Gene Fusions or Other FGFR Genetic Alterations

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Sameek Roychowdhury · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well infigratinib works in treating solid tumors that have spread to other places in the body (advanced or metastatic) in patients with FGFR gene mutations such as FGFR1-3 gene fusions or other FGFR genetic alterations. Mutations are any changes in the genetic material (DNA) of a cell. FGFR proteins are involved in cell division, cell maturation, formation of new blood vessels, wound healing, and bone growth, development, and maintenance. FGFR mutations can cause the FGFR protein to become over-active in diseases such as cancer. Infigratinib may stop the growth of tumor cells by blocking FGFR proteins in these tumors.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of single agent infigratinib in patients with advanced or metastatic solid tumors of any histologic classification with FGFR1-3 gene fusions/translocations or other FGFR genetic alterations (with and without prior therapy with different FGFR inhibitor). II. To understand response rate and potential for infigratinib to benefit patients who have FGFR alterations including point mutations, insertions/deletions and amplifications in different solid tumor types. SECONDARY OBJECTIVES: I. To further evaluate the efficacy of single agent infigratinib. II. To characterize the safety and tolerability of single agent infigratinib. II. To evaluate benefit of infigratinib in patients who have received one prior FGFR inhibitor. EXPLORATORY OBJECTIVES: I. To detect biomarkers of resistance to infigratinib treatment through tumor sequencing. II. To develop a circulating tumor deoxyribonucleic acid (DNA) (ctDNA) or liquid biopsy assay optimized for monitoring response to infigratinib and detecting emerging resistance mutations to infigratinib. OUTLINE: Patients receive infigratinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who complete study treatment for any reason other than disease progression are followed for 30 days, every 8 weeks until disease progression, and then every 4 months for 1 year. All other patients are followed for 30 days, and then every 4 months for 1 year.

Conditions

• Advanced Malignant Solid Neoplasm
• Cholangiocarcinoma
• Metastatic Malignant Solid Neoplasm
• Refractory Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Infigratinib	Given PO

Timeline

• Start date: 2020-01-16
• Primary completion: 2023-12-12
• Completion: 2024-12-12
• First posted: 2020-01-18
• Last updated: 2026-02-24
• Results posted: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study