Study on Erdafitinib for Cancers with FGFR Mutations or Fusions

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06351371

Provider View

This clinical trial is testing the effectiveness of erdafitinib, a medication that targets specific genetic changes in cancer cells, in treating patients with tumors that have FGFR mutations or fusions. The study aims to see if erdafitinib can help stop cancer growth and reduce tumor size.

Patient Parameters

Program Overview

This study is exploring how well erdafitinib, a drug that blocks abnormal proteins in cancer cells, works in treating patients with advanced cancers that have specific genetic changes called FGFR mutations or fusions. By blocking these proteins, erdafitinib may help stop cancer cells from growing and potentially kill them. The trial involves taking erdafitinib daily in 28-day cycles, along with regular check-ups, scans, and blood tests to monitor the treatment's effects.

Description

The main goal of this study is to see how many patients experience a reduction in tumor size after taking erdafitinib. Researchers will also look at how long patients live without their cancer getting worse and identify any genetic markers that might predict how well the treatment works.

Participants will take erdafitinib by mouth once a day for 28 days, with cycles repeating as long as the treatment is effective and side effects are manageable. Throughout the study, patients will have regular blood tests, scans, and possibly tumor biopsies to track their progress. After finishing the treatment, patients will have follow-up visits every three months for two years, then every six months for one year.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the MATCH Master Protocol before joining this study.
  • Must have a specific genetic change in their cancer called an FGFR mutation or fusion.
  • Must have a recent electrocardiogram (ECG) showing no major heart issues.
  • Cannot have allergies to erdafitinib or similar drugs.
  • Cannot have current eye problems affecting the cornea or retina.
  • Cannot be taking medications that raise calcium or phosphate levels in the blood.
  • Cannot have a history of high phosphate levels in the blood.
  • Cannot have taken certain strong medications that affect liver enzymes within two weeks before starting the study.
  • Cannot have previously used FGFR-targeted treatments, except for certain non-selective ones.
  • Cannot have kidney or hormone issues affecting calcium or phosphate balance.
  • Cannot have bladder or urinary tract cancer; these patients should join other specific studies.
  • Must have good kidney function.
  • Cannot have high phosphate levels that cannot be controlled before starting treatment.
  • Cannot have serious heart conditions or recent heart events.
  • Cannot have problems with wound healing.
  • Women of childbearing potential must use effective birth control during the study and for four months after. Men must use condoms with spermicide and not donate sperm during the study and for five months after.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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