Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- Cholangiocarcinoma
- Metastatic Malignant Solid Neoplasm
- Refractory Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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)...
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.
Tracking Information
- NCT #
- NCT04233567
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Sameek Roychowdhury, M.D. Ohio State University Comprehensive Cancer Center