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

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT05789589
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • Brain Metastases, Adult
  • Cancer
  • Metastasis
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azeliragon — DRUG
    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)
  • Stereotactic radiosurgery — RADIATION
    Patients will undergo standard of care SRS as per the treating facility's policies.
  • Corticosteroid — DRUG
    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).

Study Details

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).

Key Dates

Start date
Nov 17, 2023
Status verified
Mar 2026
Primary completion
Mar 16, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Azeliragon and Stereotactic Radiosurgery (SRS)
    In the Phase 1 portion of the study, three treatment regimens will be systematically evaluated: 1. Azeliragon + SRS + loading corticosteroid dose (LD) + corticosteroid taper (CT) 2. Azeliragon + SRS + loading corticosteroid dose (LD) 3. Azeliragon + SRS The starting cohort will receive Regimen #2, and depending on the tolerability, participants will be allocated to subsequent cohorts as follows: if Regimen #2 is not well tolerated, participants will be allocated to Regimen #1; if #2 is well tolerated, participants will be allocated to Regimen #3. Once a Regimen has been identified as safe and tolerable, it will be used for the Phase 2 portion of the study.

Primary Outcome Measure

Total Dose-Limiting Toxicities (DLTs) [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Minesh Mehta, M.D.
[email protected]
786-596-2000
Kristy M Reyes
[email protected]
(786) 596-2000
Minesh Mehta, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Miami Cancer Institute at Baptist Health, Inc.· Miami, FL

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