Actively Recruiting
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
30
Participants Needed
27
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older
- Histologically confirmed IDH-wild type glioma (grade 2-4) according to WHO 2016 or 2021 classification
- Tumor tissue positive for FGFR-TACC gene fusion by local next generation sequencing
- Disease must be recurrent or progressive glioma after at least one prior anti-tumor treatment including surgery, radiation, or chemotherapy
- Specific progression criteria for grade 3 or 4 gliomas based on timing after chemoradiotherapy and imaging or pathology
- Specific progression criteria for grade 2 gliomas based on new lesions or increase in non-enhancing lesions
- Measurable disease on MRI as per RANO or RANO-LGG criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, or Karnofsky score of 60% or higher
- Adequate blood counts: neutrophils ≥1000/uL, hemoglobin >8 g/dL, platelets ≥100 x 10^9/L
- Liver function within specified limits unless related to Gilbert's disease or disease involvement
- Creatinine clearance greater than 30 mL/min
- Normal serum phosphate level
- Recovery from toxic effects of prior treatments
- HIV patients on effective therapy with undetectable viral load within 6 months are eligible
- Patients with controlled hepatitis B or cured hepatitis C are eligible
- New York Heart Association Functional Classification class 2B or better
- Women of childbearing potential and men must agree to use contraception during and one month after the study
- Ability to understand and sign informed consent (or legal representative able to consent)
You will not qualify if you...
- Receiving any other investigational agents
- History of allergic reactions to drugs similar to erdafitinib
- Use of medications that are moderate CYP2C9 inducers or strong CYP3A4 inducers
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding women
- Current central serous retinopathy or retinal pigment epithelial detachment
- Corrected QT interval prolongation (QTc > 480 ms) on ECG at screening
- Prior treatment with FGFR inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
2
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
3
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
4
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
5
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
6
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
7
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
10
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
11
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
12
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
13
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
14
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
15
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
16
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
17
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
18
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
19
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
20
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
21
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
22
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
23
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Active, Not Recruiting
24
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
25
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
26
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
27
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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