Study on Erdafitinib for Patients with Advanced Solid Tumors and FGFR Gene Changes

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04083976

Provider View

This clinical trial is testing the effectiveness of the drug erdafitinib in treating adults and children with advanced solid tumors that have specific changes in the FGFR gene. The study focuses on how well the tumors respond to the treatment.

Patient Parameters

Program Overview

The aim of this study is to see how well the drug erdafitinib works in shrinking tumors in adults and children with advanced solid tumors that have changes in the FGFR gene. These changes can be mutations or gene fusions. The study will look at the overall response rate, which means how many patients see their tumors shrink or disappear after treatment. Currently, the study is only enrolling children.

Description

Erdafitinib is a drug that targets and blocks certain proteins (FGFR 1-4) that help cancer cells grow. It has shown promise in treating cancers like bladder cancer and bile duct cancer that have specific FGFR changes. This study is testing erdafitinib in patients with various types of advanced solid tumors that have these FGFR changes, regardless of the type of cancer.

The study has three parts: a screening phase to determine eligibility, a treatment phase where participants receive erdafitinib, and a follow-up phase to monitor participants after treatment ends. The study will continue until the last participant has completed treatment and follow-up, or until all pediatric participants have been followed for at least six months after treatment, whichever comes first.

Eligibility Criteria

Inclusion Criteria

  • Have a solid tumor that cannot be removed by surgery, has spread locally, or has spread to other parts of the body, and has changes in the FGFR gene.
  • Have a tumor that can be measured by scans or tests.
  • Have tried at least one other treatment for advanced cancer, or be a child or teenager with a newly diagnosed tumor that has no standard treatment options.
  • Have cancer that has gotten worse and needs a change in treatment before joining the study.

Exclusion Criteria

  • Have had chemotherapy, targeted therapy, or experimental cancer treatment recently (within 15 days or up to 30 days, depending on the drug).
  • Have specific FGFR mutations that make the cancer resistant to treatment.
  • Have bladder cancer.
  • Have blood cancers like leukemia or lymphoma.
  • For lung cancer patients only: have certain gene changes in EGFR, ALK, ROS1, NTRK, BRAF V600E, or KRAS.
  • Have other active cancers that need treatment.

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