Actively Recruiting
Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases
Led by Baptist Health South Florida · Updated on 2026-03-04
46
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
M
Miami Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine the safety and efficacy of using the drug azeliragon combined with stereotactic radiosurgery. Specifically, to determine if this combination will lead to improved response in the brain (tumor shrinking in size) and overall tumor control (how long tumor remains controlled).
CONDITIONS
Official Title
Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of cancer within the past 5 years, or recent biological or pathological confirmation if original diagnosis was over 5 years ago
- Age 18 years or older
- Karnofsky performance status of 50 or higher or ECOG score of 3 or lower
- Brain metastasis with the largest tumor diameter 2 cm or less
- Discontinued corticosteroids at least 5 days prior to stereotactic radiosurgery (unless given as part of this study)
- Not pregnant or breastfeeding; effective contraception required for patients of childbearing potential during and 6 months after treatment
- Prior stereotactic radiosurgery allowed if new untreated brain lesions and at least 2 months since previous cranial radiation
- Adequate blood counts at screening: ANC ≥ 1.0 x 10^9/L, platelets ≥ 75,000/mm^3, hemoglobin ≥ 9 g/dL without transfusion or growth factors
- Liver enzymes and bilirubin within 2.5 times upper limit of normal; creatinine clearance over 60 mL/min
You will not qualify if you...
- Presence of leptomeningeal disease
- Inability to undergo magnetic resonance imaging (MRI)
- Use of Cytochrome P450 2C8 inhibitors as specified in the protocol
- Gastrointestinal conditions interfering with swallowing or absorption
- Females or males unwilling to use highly effective contraception during the trial and for 6 months after last azeliragon dose
- Participation in another interventional clinical trial or investigational agent use within 7 days before starting azeliragon
- Any condition judged by the principal investigator to make the patient unsuitable for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
M
Minesh Mehta, M.D.
CONTACT
K
Kristy Reyes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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