RecruitingPhase 1Phase 2NCT05789589

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

A Phase I/II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases

Sponsor

Baptist Health South Florida

Enrollment

46 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Cancer Metastatic Cancer Metastasis Brain Metastases, Adult Brain Metastases

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called azeliragon, combined with stereotactic radiosurgery (a very precise type of radiation targeting specific brain tumors), can improve outcomes for people with brain metastases. Azeliragon may help make cancer cells more sensitive to radiation. **You may be eligible if...** - You are 18 or older with a confirmed cancer diagnosis - You have brain metastases (cancer that has spread to the brain) with the largest tumor being 2 cm or smaller in diameter - Your overall health status is reasonable (Karnofsky ≥ 50 or ECOG ≤ 3) - You are not currently taking steroids for your brain metastases (or have stopped at least 5 days before treatment) - You are using effective birth control if applicable **You may NOT be eligible if...** - Your brain tumors are larger than 2 cm - You are pregnant or breastfeeding - Your lab values show poor organ function - You are currently on medications that interact significantly with azeliragon Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzeliragon

Dosing will begin on Day 0 with the loading dose and continue daily through Day 7. Starting on Day 8, dosing will resume with the continuous dose until disease progression or 8 weeks. If there is evidence of antitumor effect at 8 weeks, dosing may continue for up 2 two years. All doses are taken orally. There are three levels of dosing, including a starting dose and two lower levels of dosing. Participants will start with the starting dose, and in the event of the dose limiting toxicities, the dose will be reduced as described below. Starting Dose Level: 30 mg twice daily (Loading Dose) or 20 mg once daily (Continuous Dose) Dose Level -1: 15 mg twice daily (Loading Dose) or 10 mg once daily (Continuous Dose) Dose Level -2: 15 mg once daily (Loading Dose) or 5 mg once daily (Continuous Dose)

RADIATIONStereotactic radiosurgery

Patients will undergo standard of care SRS as per the treating facility's policies.

DRUGCorticosteroid

Two corticosteroid regimens are used depending on the study cohort. Cohorts 1 and 2 will receive the loading dose (LD). Only Cohort 1 will receive the corticosteroid taper (CT). LD: Oral (8 mg) or IV bolus dose (10 mg) of dexamethasone or 40 to 80 mg of methylprednisolone on the day of SRS CT: Oral 2-4 mg of dexamethasone twice daily for 5 days and then 2-4 mg daily for 5 days at the discretion of the treating physician (concurrent use of a proton pump inhibitor or H2 receptor antagonists are encouraged during the CT).