Actively Recruiting
A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion
Led by National Cancer Institute (NCI) · Updated on 2026-06-02
30
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating erdafitinib, a kinase inhibitor, in patients with recurrent or progressive IDH-wild type gliomas that have an FGFR-TACC gene fusion. These gliomas have returned or worsened after initial treatment. Erdafitinib works by blocking an abnormal FGFR protein that signals tumor cells to multiply, potentially slowing tumor growth or shrinking tumors. The study is a phase II clinical trial aiming to assess erdafitinib's anti-tumor activity, safety, and effects on survival. Participants receive erdafitinib orally once daily for 28-day cycles, continuing until the disease progresses or unacceptable side effects occur. The trial includes a dose-escalation phase followed by a dose-expansion phase. Throughout the study, patients undergo magnetic resonance imaging (MRI), optical coherence tomography (OCT), and blood sample collections. Tissue sample collection is optional. After completing the study treatment, participants are followed up every three months for two years. During the trial, researchers monitor tumor response using imaging and collect biological samples to understand treatment effects. They measure outcomes such as objective response rate, progression-free survival at six months, overall survival, and treatment safety through reported adverse events. The study duration includes treatment cycles plus a two-year follow-up period to evaluate long-term outcomes and safety.
CONDITIONS
Brief 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-WT gliomas (grade 2-4) per WHO 2016 or 2021 classification
- Tumor tissue positive for FGFR-TACC gene fusion by local CLIA-approved next generation sequencing assay
- Disease must be recurrent or progressive glioma after at least one prior treatment including surgery, radiation, or chemotherapy
- For grade 3 or 4 glioma with progression less than 12 weeks post-chemoradiotherapy, progression defined by new enhancement outside radiation field or histologic evidence of viable tumor
- For grade 3 or 4 glioma with progression 12 weeks or more post-chemoradiotherapy, progression defined by new lesions, size increase, or increased T2/FLAIR lesions on corticosteroids
- For grade 2 glioma, progression defined by new lesions, increased enhancement, or 25% increase in T2/FLAIR lesions on corticosteroids
- Measurable disease by MRI as per RANO or RANO-LGG criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky score 60% or higher
- Adequate blood counts and organ function including neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, creatinine clearance, and normal phosphate levels
- Recovery from prior surgery, radiation, or chemotherapy toxic effects
- HIV patients on effective therapy with undetectable viral load within 6 months
- Controlled hepatitis B or cured hepatitis C infections
- New York Heart Association Functional Classification class 2B or better
- Use of adequate contraception for women of childbearing potential and men
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving other investigational agents
- History of allergic reactions to compounds similar to erdafitinib
- Use of moderate CYP2C9 or strong CYP3A4 inducers
- Uncontrolled intercurrent illnesses
- Pregnant or breastfeeding women
- Current central serous retinopathy or retinal pigment epithelial detachment
- Prolonged QTc interval (>480 ms) on ECG at screening
- Previous treatment with FGFR inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive erdafitinib orally once daily on days 1-28 of each 28-day cycle. They also undergo MRI, OCT, and blood sample collection throughout the trial. Tissue sample collection is optional.
Visits occur every 28 days for treatment and ongoing assessments
Duration - Up to 2 years
Participants are followed up every 3 months for 2 years after completing treatment to monitor health and survival.
Quarterly visits every 3 months
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
Suspended
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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