Erdafitinib for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether erdafitinib, a medication that blocks certain proteins, can help control brain tumors called gliomas. It targets gliomas with a specific gene fusion (FGFR-TACC) that have returned or worsened after previous treatment. Erdafitinib may slow or shrink these tumors by inhibiting their growth. Suitable candidates for this trial have recurrent or progressive gliomas with the FGFR-TACC gene fusion and have already undergone standard treatments like surgery or chemotherapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from a potentially effective therapy.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but you cannot take medications that are moderate CYP2C9 inducers or strong CYP3A4 inducers. It's important to discuss your current medications with the trial team to ensure there are no interactions with erdafitinib.
Is there any evidence suggesting that erdafitinib is likely to be safe for humans?
Previous studies have shown that erdafitinib has a safety profile similar to its use in treating other cancers, such as advanced bladder cancer. Research indicates that most patients tolerated it well, experiencing side effects similar to those observed previously. Common side effects included vision changes, dry mouth, and tiredness, while serious side effects were less common. Since erdafitinib is already approved for other conditions, some understanding of its safety exists. However, as this trial is in an early stage, safety in brain cancer patients remains under investigation.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for brain cancer, which often include surgery, radiation, and chemotherapy, erdafitinib targets cancer cells through a different mechanism. Erdafitinib is a fibroblast growth factor receptor (FGFR) inhibitor, which means it specifically blocks signals that certain cancer cells need to grow and multiply. This targeted approach can potentially lead to more effective treatment with fewer side effects compared to traditional options. Researchers are excited about erdafitinib because it offers a new way to tackle brain cancer by honing in on a specific pathway used by cancer cells, which could be a game-changer for patients with tumors that have these FGFR alterations.
What evidence suggests that erdafitinib might be an effective treatment for brain cancer?
Research has shown that erdafitinib, which participants in this trial will receive, may help treat certain brain tumors. In some studies, patients with brain tumors featuring FGFR changes, similar to those in this trial, experienced halted cancer growth. Another study found that erdafitinib slowed tumor growth in patients with FGFR-related cancers. On average, patients went about 5.2 months without their cancer worsening and lived for about 10.9 months overall. These results suggest that erdafitinib could help manage tumor growth in patients with this specific type of brain cancer.12346
Who Is on the Research Team?
Macarena I De La Fuente
Principal Investigator
University Health Network Princess Margaret Cancer Center LAO
Are You a Good Fit for This Trial?
Adults with specific brain cancers called IDH-wild type gliomas that have returned or worsened, despite previous treatments. Participants must be over 18 and have tumors with a particular gene fusion (FGFR-TACC). The cancer should show growth on scans and not be due to other conditions like radiation effects or infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
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. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
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