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.
PRIMARY OBJECTIVE: I. To assess the preliminary anti-tumor activity of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion as measured by the best response at any time during treatment in terms of objective response rate (ORR). SECONDARY OBJECTIVES: I. To determine the safety and tolerability of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion. II. To assess the overall survival (OS) of erdafitinib in patients with recurrent or progressive IDH-WT glioma with FGFR-TACC gene fusion. III. To assess the progression free survival (PFS) at 6 months of patient with IDH-WT glioma with FGFR-TACC gene fusion treated with erdafitinib. OUTLINE: This is a dose-escalation study of erdafitinib followed by a dose-expansion study. Patients receive erdafitinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI), optical coherence tomography (OCT), and collection of blood samples throughout the trial. After study completion, patients are followed up every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Undergo collection of blood samples
Given PO
Undergo MRI
Undergo OCT
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGUM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
RECRUITINGUM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
RECRUITINGUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Objective response rate
Defined as the proportion of patients with either complete response or partial response as per Response Assessment in Neuro-Oncology criteria. The response rate will be estimated along with the corresponding 95% confidence interval using the binomial exact method. Univariable and multivariable logistic regression models will be used to estimate the associations between study covariates and response status. Odds ratios and corresponding 95% confidence intervals and p-values will be reported.
Time frame: Up to 2 years
Incidence of dose-limiting toxicities
Analyzed based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 28 days
Incidence of adverse events (AEs) and serious AEs
Analyzed based on NCI CTCAE version 5.0.
Time frame: Up to 2 years
Progression-free survival
Kaplan-Meier method will be used to estimate survival rates for pre-specified time points along with 95% confidence intervals. Hazard ratios (HRs) will be estimated using Cox proportional hazards regression model to examine the associations of study covariates with time-to-event outcomes along with corresponding 95% confidence intervals and p-values if these are estimable.
Time frame: Time between date of enrollment and date of progression or date of death from any cause, assessed at 6 months
Overall survival
Kaplan-Meier method will be used to estimate survival rates for pre-specified time points along with 95% confidence intervals. HRs will be estimated using Cox proportional hazards regression model to examine the associations of study covariates with time-to-event outcomes along with corresponding 95% confidence intervals and p-values if these are estimable.
Time frame: Time between the date of enrollment and date of death from any cause, censored at the last date of follow-up, assessed up to 2 years
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Memorial Hospital East
Shiloh, Illinois, United States
RECRUITINGSiteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
RECRUITINGSiteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGSiteman Cancer Center-South County
St Louis, Missouri, United States
RECRUITINGSiteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
RECRUITING...and 17 more locations