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NCT05859334 · ClinicalTrials.gov registry record · Phase 2
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
A Phase 2 study of Recurrent Glioma and Recurrent WHO Grade 4 Glioma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT05859334: Recruiting Phase 2 study of Recurrent Glioma and Recurrent WHO Grade 4 Glioma, sponsored by National Cancer Institute (NCI).
NCT05859334 is a Phase 2 study of Recurrent Glioma and Recurrent WHO Grade 4 Glioma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 67-participant average among 12 other Recurrent Glioma trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05859334, a Phase 2 study of Recurrent Glioma and Recurrent WHO Grade 4 Glioma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 Outcome
Defined as the proportion of patients with either complete response or partial response as per Response Assessment in Neuro-Oncology (RANO) or RANO-low-grade glioma 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
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Optical Coherence Tomography
- DRUG Erdafitinib
Study Locations (20)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Hackensack University Medical Center - Hackensack
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Memorial Hospital East - Shiloh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-01-04 |
| Est. Completion | 2026-10-23 |
| Phase | Phase 2 |
What NCT05859334 shows while recruiting
NCT05859334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 67-participant average among 12 other Recurrent Glioma trials with a reported enrollment target (55% lower).
The record links to 4 conditions, with Recurrent Glioma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05859334 names 20 study sites across 6 states, led by New York, Missouri, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05859334 about?
NCT05859334 is a clinical study titled "Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment". 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...
What is the current status of trial NCT05859334?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-01-04. Estimated completion is 2026-10-23.
What conditions does trial NCT05859334 study?
This clinical trial studies the following conditions: Recurrent Glioma, Recurrent WHO Grade 4 Glioma, Recurrent WHO Grade 2 Glioma, Recurrent WHO Grade 3 Glioma.
What interventions are being tested in trial NCT05859334?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Optical Coherence Tomography (PROCEDURE), Erdafitinib (DRUG).
Who is sponsoring clinical trial NCT05859334?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05859334 being conducted?
This trial has 20 study locations across Colorado, Florida, Illinois, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05859334's enrollment target sits among peer trials
30 6th of 12 higher than 7 of 12 other Recurrent Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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