Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Follo… (NCT05859334) | Clinical Trial Compass
RecruitingPhase 2
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
United States30 participantsStarted 2024-01-04
Plain-language summary
This phase II trial tests how well erdafitinib works in controlling IDH-wild type (WT), FGFR-TACC gene fusion positive gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals tumor cells to multiply. This may help keep tumor cells from growing and may kill them. Giving erdafitinib may help to slow the growth of, or to shrink, tumor cells in patients with recurrent or progressive IDH-wild type gliomas with FGFR-TACC gene fusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be \>= 18 years of age
* Patient must have histologically confirmed IDH-WT gliomas (grade 2-4) as per World Health Organization (WHO) 2016 or 2021 classification
* Tumor tissue should be positive for FGFR-TACC gene fusion as per any local next generation sequencing (NGS) (Clinical Laboratory Improvement Act \[CLIA\]-approved) assay described in background section
* The disease should be recurrent or progressive glioma after initial anti-tumor treatment with at least 1 line of treatment including surgical resection, radiation therapy and/or chemotherapy
* For patients with WHO grade 3 or 4 glioma and progressive disease \< 12 weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:
* New enhancement outside of the radiation field (beyond the high-dose region or 80% isodose line)
* If there is unequivocal evidence of viable tumor on histopathologic sampling (e.g., solid tumor areas. i.e., \> 70% tumor cell nuclei in areas), high or progressive increase in Ki-67 proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor)
* For patients with WHO grade 3 or 4 glioma and progressive disease \>= 12 weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:
* New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids
* Increas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Erdafitinib is being tested here for brain tumors that have come back after treatment — given that my specific glioma grade is one of the ones this trial covers, does my tumor have the kind of genetic or molecular profile that this drug is actually designed to target?
2Since this is a Phase 2 trial, the main thing they're measuring is whether the tumor visibly shrinks or responds — what does that mean for what we actually know so far about how safe and effective erdafitinib is for people like me, compared to other options I might have?
3My tumor has already come back once — would it make sense to try a different standard retreatment approach before considering an experimental drug trial, or is my situation one where a trial like this might be worth prioritizing sooner?
4This trial is actively enrolling right now, which means there may still be open spots — but are there specific eligibility requirements, like prior treatments I've had to have already tried or certain test results I'd need, that could affect whether this would even be an option worth pursuing?
5What would participating in this trial actually look like day-to-day — how often would I need to come in for treatment or monitoring, and is that realistic given my current health and situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.