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

NCT04233567 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-02-24

Study results available
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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.

Conditions

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

Interventions

DRUG

Infigratinib

Given PO

Sponsors & Collaborators

  • Sameek Roychowdhury

    lead OTHER

Principal Investigators

  • Sameek Roychowdhury, M.D. · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2023-12-12
Completion
2024-12-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233567 on ClinicalTrials.gov