Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05859334
Phase
PHASE2
Status
Recruiting

Conditions

  • Recurrent Glioma
  • Recurrent WHO Grade 2 Glioma
  • Recurrent WHO Grade 3 Glioma
  • Recurrent WHO Grade 4 Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and/or tissue samples
  • Erdafitinib — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Optical Coherence Tomography — PROCEDURE
    Undergo OCT

Study Details

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.

Key Dates

Start date
Jan 4, 2024
Status verified
Mar 2026
Primary completion
Oct 23, 2026
Completion
Oct 23, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (erdafitinib)
    Patients receive erdafitinib PO 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 MRI, OCT, and collection of blood samples throughout the trial. Additionally, patients may optionally undergo collection of tissue samples on study.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 2 years ]

Locations (27)

FacilityCityStateZIPSite coordinators
UCHealth University of Colorado HospitalAuroraColorado80045
Site Public Contact
720-848-0650
Denise M. Damek (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral GablesFlorida33146
Site Public Contact
305-243-2647
Macarena I. De La Fuente (PRINCIPAL_INVESTIGATOR)
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield BeachFlorida33442
Site Public Contact
305-243-2647
Macarena I. De La Fuente (PRINCIPAL_INVESTIGATOR)
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Site Public Contact
305-243-2647
Macarena I. De La Fuente (PRINCIPAL_INVESTIGATOR)
Memorial Hospital EastShilohIllinois62269
Site Public Contact
314-747-9912
Omar H. Butt (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376
Site Public Contact
800-600-3606
Omar H. Butt (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141
Site Public Contact
800-600-3606
Omar H. Butt (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136
Site Public Contact
800-600-3606
Omar H. Butt (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center-South CountySt LouisMissouri63129
Site Public Contact
800-600-3606
Omar H. Butt (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Site Public Contact
800-600-3606
Omar H. Butt (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920
Site Public Contact
212-639-7592
Thomas J. Kaley (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Site Public Contact
551-996-2897
Deric M. Park (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748
Site Public Contact
212-639-7592
Thomas J. Kaley (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering BergenMontvaleNew Jersey07645
Site Public Contact
212-639-7592
Thomas J. Kaley (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering CommackCommackNew York11725
Site Public Contact
212-639-7592
Thomas J. Kaley (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Site Public Contact
212-639-7592
Thomas J. Kaley (PRINCIPAL_INVESTIGATOR)
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016
Site Public Contact
Jose R. McFaline Figueroa (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Site Public Contact
212-639-7592
Thomas J. Kaley (PRINCIPAL_INVESTIGATOR)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032
Site Public Contact
212-342-5162
Aya Haggiagi (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering NassauUniondaleNew York11553
Site Public Contact
212-639-7592
Thomas J. Kaley (PRINCIPAL_INVESTIGATOR)
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Site Public Contact
336-713-6771
Roy E. Strowd (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
M D Anderson Cancer CenterHoustonTexas77030
Site Public Contact
877-632-6789
Ashley E. Aaroe (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Site Public Contact
888-424-2100
Howard Colman (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718
Site Public Contact
800-622-8922
Ankush Bhatia (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
Site Public Contact
800-622-8922
Ankush Bhatia (PRINCIPAL_INVESTIGATOR)

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