Erdafitinib for Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. You cannot be on other anti-cancer agents, investigational drugs, or certain medications that affect specific liver enzymes (CYP3A4 and CYP2C9). If you're on corticosteroids, you need to be on a stable or decreasing dose for at least 7 days before joining the trial.
What data supports the effectiveness of the drug Erdafitinib (Balversa) for cancer treatment?
Is erdafitinib safe for humans?
What makes the drug erdafitinib unique for treating cancer?
Erdafitinib is unique because it is an oral drug that specifically targets and inhibits fibroblast growth factor receptors (FGFRs), which are often altered in certain cancers like urothelial carcinoma. This makes it particularly effective for patients with FGFR alterations who have not responded well to other treatments like chemotherapy.12478
What is the purpose of this trial?
This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with FGFR mutations that have spread to other places in the body and have come back or do not respond to treatment. Erdafitinib may stop the growth of cancer cells with FGFR mutations by blocking some of the enzymes needed for cell growth.
Research Team
Alice Lee
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for children and young adults aged 12 months to 21 years with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have FGFR mutations. Participants must be able to swallow tablets, have not been treated with erdafitinib before, and meet specific health criteria like normal bilirubin levels and kidney function.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive erdafitinib orally once daily on days 1-28 of each cycle, repeating every 28 days for up to 26 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Exploratory Genomic Profiling
Evaluation of changes in tumor genomics over time through circulating tumor DNA
Treatment Details
Interventions
- Erdafitinib
Erdafitinib is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
- Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor