Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases (NCT05789589) | Clinical Trial Compass
SuspendedPhase 1/2
Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases
Stopped: Funding
United States46 participantsStarted 2023-11-17
Plain-language summary
To determine the safety and efficacy of using the drug azeliragon combined with stereotactic radiosurgery. Specifically, to determine if this combination will lead to improved response in the brain (tumor shrinking in size) and overall tumor control (how long tumor remains controlled).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
. Age ≥ 18
. Karnofsky performance status ≥ 50 or Eastern Cooperative Oncology Group (ECOG) ≤ 3
. Brain metastasis with a maximum tumor diameter of the largest lesion ≤ 2 cm
. 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.)
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently listed as 'suspended' — can you find out why enrollment has been stopped, and whether that suspension is related to any safety concerns with combining azeliragon and stereotactic radiation?
2Since this is a Phase 1/2 trial primarily measuring dose-limiting toxicities, what does that mean for how much is already known about whether this combination is safe for people with brain metastases like mine?
3Stereotactic radiation is already a standard treatment for brain metastases — would it make more sense for me to pursue that on its own first, rather than waiting to see if this trial resumes?
4Azeliragon is not a widely used drug — can you explain what it does and what side effects have been seen in earlier studies that might be relevant to what I'd experience if this trial does reopen?
5If this trial remains suspended, are there other active clinical trials or established treatment combinations for brain metastases that we should be considering right now instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment):
Exclusion criteria
. Patients with leptomeningeal disease
. Patients unable to undergo magnetic resonance imaging (MRI)
. Patients receiving Cytochrome P450 (CYP) 2C8 inhibitors as indicated in the protocol
. 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 azeliragon.
. 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.
. Any patient that in the opinion of the principal investigator is not an appropriate candidate for this trial