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Recruiting Phase 1, Phase 2 NCT05789589

Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases

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Trial Parameters

Condition Cancer
Sponsor Baptist Health South Florida
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 46
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-17
Completion 2027-03-16
Interventions
AzeliragonStereotactic radiosurgeryCorticosteroid

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Brief Summary

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).

Eligibility Criteria

Inclusion Criteria: 1. Patient must have histologically or cytologically confirmed diagnosis of cancer within the past 5 years. If original histologic proof of malignancy is \> 5 years, then biological \[such as presence of tumor markers, circulating tumor (ctDNA), etc.\], or pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis) 2. Age ≥ 18 3. Karnofsky performance status ≥ 50 or Eastern Cooperative Oncology Group (ECOG) ≤ 3 4. Brain metastasis with a maximum tumor diameter of the largest lesion ≤ 2 cm 5. Patients must have discontinued corticosteroids at least 5 days prior to SRS. (Note: This does not apply to corticosteroids administered as part of this protocol.) 6. Patients must not be pregnant (positive pregnancy test) or breast feeding. Effective contraception (men and women) must be used in patients of child-bearing potential during radiotherapy and for 6 months after. 7. Patients who have received prior SRS are eligible

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