35 Participants Needed

Erdafitinib for Brain Cancer

Recruiting at 31 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

MI

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

I can understand and am willing to sign the consent form myself or have someone legally authorized to do so on my behalf.
I am HIV positive, on treatment, and my viral load is undetectable.
My high-grade brain tumor has worsened 12 weeks after finishing treatment.
See 14 more

Exclusion Criteria

Pregnant women are excluded from this study
Patients with uncontrolled intercurrent illness
History of allergic reactions attributed to compounds of similar chemical or biologic composition to erdafitinib
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 2 years
Monthly visits for MRI, OCT, and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

2 years
Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Erdafitinib
Trial Overview The trial is testing Erdafitinib, a drug designed to block abnormal proteins in tumor cells which may slow down or shrink the growth of recurrent or progressive brain tumors. It includes imaging tests like MRI and collecting tissue samples to study the drug's effect.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (erdafitinib)Experimental Treatment4 Interventions

Erdafitinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Balversa for:
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Approved in European Union as Balversa for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Erlotinib shows promise for treating brain metastases in non-small cell lung cancer (NSCLC) patients, particularly those with EGFR mutations, as it can penetrate the central nervous system and has demonstrated objective responses in preclinical and retrospective studies.
However, in non-EGFR mutation enriched populations, adding erlotinib to radiotherapy did not improve progression-free or overall survival, indicating that its use remains investigational and may be most beneficial for specific patient groups.
Erlotinib for the treatment of brain metastases in non-small cell lung cancer.Brower, JV., Robins, HI.[2018]
Gefitinib, a medication used for non-small-cell lung cancer (NSCLC), has shown clinical activity in some patients with brain metastases, leading to improvements in neurological and systemic symptoms.
Case studies indicate that gefitinib can result in partial and even complete responses in brain metastases, suggesting the need for larger trials to better understand its efficacy and potential role in treatment, especially in combination with radiotherapy.
Quality-of-life benefits and evidence of antitumour activity for patients with brain metastases treated with gefitinib.Katz, A., Zalewski, P.[2018]
Erlotinib, a drug that targets the epidermal growth factor receptor (EGFR), was well tolerated in a study involving four adult rhesus monkeys, showing a mean terminal half-life of 5.2 hours after intravenous administration.
Both erlotinib and its active metabolite OSI-420 were detectable in cerebrospinal fluid (CSF), but their penetration was limited to less than 5% of total plasma concentrations, although CSF exposure was about 30% of the free drug exposure in plasma.
The plasma and cerebrospinal fluid pharmacokinetics of erlotinib and its active metabolite (OSI-420) after intravenous administration of erlotinib in non-human primates.Meany, HJ., Fox, E., McCully, C., et al.[2015]

Citations

Use of BALVERSA in Central Nervous System CancersOf the 7 patients who reported SD as their best confirmed response to BALVERSA, 4 patients had FGFR-alterations and brain tumors.
Tumour-agnostic efficacy and safety of erdafitinib in patients ...We aimed to evaluate the safety and efficacy of erdafitinib in a phase 2 study of previously treated patients with FGFR-altered advanced solid tumours.
Janssen Presents Initial Results from the Phase 2 ...Data from RAGNAR, the largest tumor-agnostic study reported for a targeted therapy and the first to evaluate FGFR-driven malignancies.
Durable benefit and slowdown in tumor growth dynamics with ...In the next MRI performed 4 months after the start of erdafitinib a 5% increase in tumor size can be seen. Nevertheless, in early June 2023, 3 ...
Erdafitinib Induces Positive Initial Results for FGFR-Driven ...Additionally, median progression-free survival (PFS) was 5.2 months (95% CI, 4.0-5.6), and the median overall survival (OS) was 10.9 months (95% ...
212018Orig1s000 - accessdata.fda.govThe safety profile of erdafitinib is acceptable in this setting. ... The erdafitinib clinical safety database contains pooled data from a ...
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