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

Launched by BAPTIST HEALTH SOUTH FLORIDA · Mar 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat patients with brain metastases, which are cancer tumors that have spread to the brain. Researchers want to find out if combining a medication called azeliragon with a specific type of radiation therapy known as stereotactic radiosurgery can help shrink these tumors more effectively and keep them under control for a longer time. The trial is currently recruiting participants who are adults aged 18 and older, have been diagnosed with cancer within the last five years, and have brain metastases that meet certain size criteria.

To be eligible, participants must be in reasonably good health, meaning they can perform daily activities without significant difficulty. They should not be pregnant or breastfeeding and must use effective birth control if they can have children. Those who have had previous radiation for brain tumors may still qualify if they have new, untreated lesions. Participants can expect regular health assessments and monitoring throughout the trial to ensure their safety. This study could provide valuable information on a new treatment option for those facing brain metastases.

Gender

ALL

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, provided that there are new non-irradiated brain lesions and that the patient is ≥ 2 months post prior cranial radiation therapy
• 8. Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment):
• • Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L
• • Platelet count ≥ 75,000/mm\^3 (75 × 10\^9/L)
• • Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support
• • 9. Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L; Platelet count ≥ 75,000/mm\^3 (75 × 10\^9/L); Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support
• 10. Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment):
• • Aspartate aminotransferase (AST; SGOT), alanine transaminase (ALT; SGPT) ≤ 2.5 × upper limit of normal range (ULN). Total bilirubin ≤ 1.5 × ULN.
• • Estimated creatinine clearance of \> 60 mL/min (per Cockcroft-Gault formula)
• Exclusion Criteria:
• • 1. Patients with leptomeningeal disease
• • 2. Patients unable to undergo magnetic resonance imaging (MRI)
• • 3. Patients receiving Cytochrome P450 (CYP) 2C8 inhibitors as indicated in the protocol
• • 4. Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
• • 5. Females of childbearing potential who are sexually active or males with female partners of childbearing potential, where either the female or the male is unwilling to use a highly effective method of contraception during the trial and for 6 months after the last administration of azeliragon.
• • 6. Patients with concurrent participation in another interventional clinical trial or use of another investigational agent within 7 days of starting azeliragon. Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
• • 7. Any patient that in the opinion of the principal investigator is not an appropriate candidate for this trial