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Kinase Inhibitor
Erdafitinib for Brain Cancer
Phase 2
Recruiting
Led By Macarena I De La Fuente
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will test a drug (erdafitinib) to see if it can help slow/shrink IDH-WT gliomas with an abnormal FGFR protein.
Who is the study for?
Adults with specific brain cancers called IDH-wild type gliomas that have returned or worsened, despite previous treatments. Participants must be over 18 and have tumors with a particular gene fusion (FGFR-TACC). The cancer should show growth on scans and not be due to other conditions like radiation effects or infections.Check my eligibility
What is being tested?
The trial is testing Erdafitinib, a drug designed to block abnormal proteins in tumor cells which may slow down or shrink the growth of recurrent or progressive brain tumors. It includes imaging tests like MRI and collecting tissue samples to study the drug's effect.See study design
What are the potential side effects?
Erdafitinib can cause side effects such as fatigue, diarrhea, dry skin, changes in nail and hair health, mouth sores, decreased appetite, altered taste sensation, muscle pain and could potentially affect liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Incidence of adverse events (AEs) and serious AEs
Incidence of dose-limiting toxicities (DLTs)
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (erdafitinib)Experimental Treatment4 Interventions
Patients receive erdafitinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI, OCT, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Optical Coherence Tomography
2016
Completed Phase 2
~1510
Biospecimen Collection
2004
Completed Phase 2
~1700
Erdafitinib
2017
Completed Phase 2
~150
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,669 Previous Clinical Trials
40,926,286 Total Patients Enrolled
322 Trials studying Glioblastoma
23,080 Patients Enrolled for Glioblastoma
Macarena I De La FuentePrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the clinical trial populated by participants?
"That is correct. Clinicaltrials.gov has indicated that this study, which was initially released on July 19th 2024, is actively recruiting patients. 35 individuals must be recruited from one medical centre for the trial to move forward."
Answered by AI
Has erdafitinib been officially sanctioned by the FDA?
"This Phase 2 trial does not have data backing its efficacy yet, so the safety rating of erdafitinib was assessed as a 2."
Answered by AI
Are there still vacancies available for participants in this research?
"Affirmative. Clinicaltrials.gov affirms that the trial, initially posted on July 19th 2024, is still in search of 35 people to partake at a single site. The post was last updated 11/15/2023"
Answered by AI
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