Study on Azeliragon and Stereotactic Radiation Therapy for Patients with Brain Metastases
Sponsor: Baptist Health South Florida
Sponsor score: 0
Inactive
ClinicalTrials ID:NCT05789589
This clinical trial is testing whether combining the drug azeliragon with a precise form of radiation therapy can safely and effectively shrink brain tumors and control their growth in patients with brain metastases.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using the drug azeliragon together with a targeted radiation treatment called stereotactic radiosurgery can help shrink brain tumors and keep them under control for longer periods. Researchers aim to determine the safety and effectiveness of this combination treatment in patients with brain metastases.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with cancer within the last 5 years, or have recent confirmation of cancer if diagnosed more than 5 years ago.
- Aged 18 years or older.
- Have a performance status score indicating ability to carry out daily activities with some assistance.
- Have a brain tumor with the largest lesion measuring 2 cm or less.
- Must have stopped taking corticosteroids at least 5 days before starting radiation therapy, unless part of the study treatment.
- Not pregnant or breastfeeding, and agree to use effective birth control during treatment and for 6 months after.
- Eligible if previously treated with stereotactic radiosurgery, as long as there are new brain lesions and at least 2 months have passed since the last treatment.
- Have adequate blood counts and organ function as shown by specific blood tests taken within 14 days before joining the study.
Exclusion Criteria
- Have cancer that has spread to the membranes surrounding the brain and spinal cord.
- Unable to have an MRI scan.
- Taking certain medications that interfere with the study drug.
- Have digestive issues that affect swallowing or absorbing medication.
- Not willing to use effective birth control if of childbearing potential or have a partner who is.
- Participating in another treatment-focused clinical trial or using another experimental drug within 7 days of starting the study drug.
- Considered unsuitable for the trial by the lead researcher.
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