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 — PROCEDUREUndergo collection of blood and/or tissue samples
- Erdafitinib — DRUGGiven PO
- Magnetic Resonance Imaging — PROCEDUREUndergo MRI
- Optical Coherence Tomography — PROCEDUREUndergo 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | Site Public Contact 720-848-0650 Denise M. Damek (PRINCIPAL_INVESTIGATOR) |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | Site Public Contact 305-243-2647 Macarena I. De La Fuente (PRINCIPAL_INVESTIGATOR) |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | Site Public Contact 305-243-2647 Macarena I. De La Fuente (PRINCIPAL_INVESTIGATOR) |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | Site Public Contact 305-243-2647 Macarena I. De La Fuente (PRINCIPAL_INVESTIGATOR) |
| Memorial Hospital East | Shiloh | Illinois | 62269 | Omar H. Butt (PRINCIPAL_INVESTIGATOR) |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | Omar H. Butt (PRINCIPAL_INVESTIGATOR) |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | Omar H. Butt (PRINCIPAL_INVESTIGATOR) |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | Omar H. Butt (PRINCIPAL_INVESTIGATOR) |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Omar H. Butt (PRINCIPAL_INVESTIGATOR) |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Omar H. Butt (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | Site Public Contact 212-639-7592 Thomas J. Kaley (PRINCIPAL_INVESTIGATOR) |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Site Public Contact 551-996-2897 Deric M. Park (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | Site Public Contact 212-639-7592 Thomas J. Kaley (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | Site Public Contact 212-639-7592 Thomas J. Kaley (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | Site Public Contact 212-639-7592 Thomas J. Kaley (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | Site Public Contact 212-639-7592 Thomas J. Kaley (PRINCIPAL_INVESTIGATOR) |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | Site Public Contact Jose R. McFaline Figueroa (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Site Public Contact 212-639-7592 Thomas J. Kaley (PRINCIPAL_INVESTIGATOR) |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | Aya Haggiagi (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | Site Public Contact 212-639-7592 Thomas J. Kaley (PRINCIPAL_INVESTIGATOR) |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Site Public Contact 336-713-6771 Roy E. Strowd (PRINCIPAL_INVESTIGATOR) |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | - |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | - |
| M D Anderson Cancer Center | Houston | Texas | 77030 | Ashley E. Aaroe (PRINCIPAL_INVESTIGATOR) |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | Howard Colman (PRINCIPAL_INVESTIGATOR) |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Madison | Wisconsin | 53718 | Ankush Bhatia (PRINCIPAL_INVESTIGATOR) |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | Ankush Bhatia (PRINCIPAL_INVESTIGATOR) |
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