NCT06724926
Concurrent Azeliragon With Craniospinal Irradiation
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentNYU Langone HealthInvestigator-initiated
~21 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:AzeliragonCSI
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients with Dose-Limiting Toxicities (DLTs) at Dose Level 1
Measured over Up to Week 4
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Jonathan Yang, MD, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patient with solid tumor malignancy or high grade glioma with leptomeningeal metastasis established radiographically and/or through cerebrospinal fluid (CSF) cytology
Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastasis
Patients with Karnofsky Performance Status of 60 or greater.
Male or non-pregnant and non-lactating female and ≥ 18 years of age.
Patients with absolute neutrophil count (ANC) ≥ 1.0 × 109/L, platelet count ≥ 75,000/mm3 (75 × 109/L), and hemoglobin (Hgb) ≥ 8 g/dL. Transfusion or growth factor support is allowed.
Patients with aspartate aminotransferase (AST) \[serum glutamic-oxaloacetic transaminase(SGOT)\], alanine aminotransferase (ALT) \[serum glutamic-pyruvic transaminase (SGPT)\] ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are present, then ≤ 5 x ULN is acceptable, total bilirubin ≤ 1.5 × ULN, and estimated creatinine clearance of \> 30 mL/min (per Cockroft-Gault formula).
Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Exclusion
Patient has a life expectancy, per investigator assessment, of less than 2 months.
Patients unable to complete the English quality of life questionnaires
Patient with extensive systemic disease and who declined standard systemic treatment options
Patient who is unable to undergo magnetic resonance imaging (MRI) brain and spine with gadolinium contrast
Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerance
Active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy.
Patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity.
Patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication.
Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
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 study drug.
Pregnant or lactating women
What this trial measures
- Number of Patients with Dose-Limiting Toxicities (DLTs) at Dose Level 1Up to Week 4
DLTs assess using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
- Number of Patients with DLTs at Dose Level -1Up to Week 4
DLTs assess using CTCAE v 5.0.
- Number of Patients with DLTs at Dose Level -2Up to Week 4
DLTs assess using CTCAE v 5.0.