A Phase II Study of Erdafitinib in Patients Whose Tumors Have an FGFR Alteration

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Full Title

A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations

Purpose

Alterations in a protein called FGFR can make cancers grow more rapidly, leading to the development and spread of cancer cells. The purpose of this study is to assess the safety and effectiveness of the investigational drug erdafitinib in adults with advanced cancers containing alterations in the FGFR protein.

Erdafitinib blocks the activity of the FGFR alteration, which may slow or stop the growth of cancer cells. The FDA has approved erdafitinib as a treatment for some cancers of the bladder and/or urinary tract that have an FGFR alteration, but the drug has not been approved as a treatment for any other cancers. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an inoperable, locally advanced, or metastatic solid tumor containing an FGFR alteration.
  • Patients’ cancers must persist despite at least one prior regimen of therapy for advanced disease.
  • At least 30 days must pass between the completion of prior therapy and entry into the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gopakumar Iyer at 646-888-4737.

Protocol

20-069

Phase

II

Investigator

Co-Investigators