Study on Erdafitinib for Treating Cancers with FGFR Gene Amplifications

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06308822

Provider View

This clinical trial is testing the effectiveness of the drug erdafitinib in treating patients with cancers that have extra copies of the FGFR gene. Erdafitinib works by blocking a protein that helps cancer cells grow.

Patient Parameters

Program Overview

The purpose of this study is to see how well the drug erdafitinib works in treating patients with advanced cancers that have more copies of the FGFR gene than normal. Erdafitinib is a type of medication called a kinase inhibitor, which blocks the action of a protein that signals cancer cells to multiply. Patients will take erdafitinib by mouth once a day in 28-day cycles, as long as the cancer does not progress or cause unacceptable side effects. Throughout the study, patients will have CT and MRI scans, and may also have blood tests and tumor biopsies. After finishing the treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 1 year.

Description

The main goal of this study is to find out how many patients experience a reduction in their cancer with erdafitinib treatment. The study also aims to see how many patients are alive and have no cancer progression after 6 months of treatment, and to measure the time until the cancer progresses or the patient passes away. Researchers will also look for other markers that might predict how well the treatment works or why it might stop working, using various tests on tumor samples and imaging scans.

Patients will take erdafitinib by mouth once a day for 28 days, with each cycle repeating every 28 days unless the cancer progresses or side effects become too severe. During the study, patients will have regular CT and MRI scans, and may also have blood tests and tumor biopsies. After completing the study treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 1 year.

Eligibility Criteria

Inclusion Criteria

  • Must meet eligibility criteria from the main MATCH Protocol before joining this study.
  • Must have extra copies of the FGFR gene as determined by the MATCH Protocol.
  • Must have a recent ECG with no significant heart issues.
  • Cannot have allergies to erdafitinib or similar drugs.
  • Cannot have current eye disorders affecting the cornea or retina.
  • Cannot be using medications that raise calcium or phosphate levels in the blood.
  • Cannot have a history of high phosphate levels.
  • Cannot have used certain strong medications affecting liver enzymes recently.
  • Cannot have used FGFR-targeted inhibitors before, except for certain non-selective ones.
  • Cannot have kidney or hormone issues affecting calcium or phosphate balance.
  • Cannot have bladder or urothelial cancer; these patients should join other specific studies.
  • Must have good kidney function.
  • Cannot have high phosphate levels despite treatment.
  • Cannot have serious heart conditions or recent heart events.
  • Cannot have poor wound healing or open wounds.
  • Women of childbearing potential must use effective birth control during and after the study. Men must use condoms with spermicide and not donate sperm during and after the study.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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