Could a Drug-Radiation combo tame brain tumors?
NCT ID NCT05789589
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the drug azeliragon to targeted radiation therapy can safely shrink brain tumors and keep them under control longer. It involves 46 adults with cancer that has spread to the brain. The goal is to improve tumor control without causing serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2023
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Brain metastases are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can colorectal surgery patients go home in two days?
- Can doctors watch brain metastases instead of zapping them?
- Can a personal navigator help young cancer patients through treatment?
- Can a smartwatch predict which cancer patients return to hospital?
- Two-Drug combo aims to stall advanced breast cancer
- Can pulsed radiation extend life in metastatic cervical cancer?