Combining azeliragon with stereotactic radiation therapy for 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
This study is testing if adding a new drug called azeliragon to a type of targeted radiation therapy can help people with brain metastases shrink their tumors and improve their treatment outcomes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baptist Health South Florida Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05789589 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of azeliragon when used in conjunction with stereotactic radiosurgery in patients with brain metastases. The study will assess whether this combination can lead to a reduction in tumor size and improved overall tumor control. Participants will receive azeliragon along with corticosteroids and undergo stereotactic radiation therapy as part of their treatment regimen. The trial is designed for patients with confirmed cancer diagnoses and specific eligibility criteria regarding their health status and tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed cancer and brain metastases measuring 2 cm or less.
Not a fit: Patients with larger brain metastases or those who have not discontinued corticosteroids prior to treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could enhance tumor response and control in patients with brain metastases.
How similar studies have performed: While the combination of azeliragon and stereotactic radiosurgery is a novel approach, similar studies have shown promise in treating brain metastases with targeted therapies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Minesh Mehta, M.D. — Miami Cancer Institute at Baptist Health, Inc.
- Study coordinator: Minesh Mehta, M.D.
- Email: mineshm@baptisthealth.net
- Phone: (786) 596-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.