CancerPhase 1/2ADORATIONNCT05789589
Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases
A Phase 1/2 study testing Azeliragon, Stereotactic radiosurgery and Corticosteroid in people with Cancer and Metastasis, run by Baptist Health South Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Metastasis, Metastatic Cancer
- What is being tested?
- Azeliragon, Stereotactic radiosurgery and Corticosteroid
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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):
- 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
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
About this study
Official title: 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
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).
- Conditions
- Cancer, Metastasis, Metastatic Cancer, Brain Metastases, Brain Metastases, Adult
- Being tested
- Azeliragon, Stereotactic radiosurgery, Corticosteroid
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzeliragonDrug
Also called TTP488, PF-04494700
Dosing will begin on Day 0 with the loading dose and continue daily through Day 7. Starting on Day 8, dosing will resume with the continuous dose until disease progression or 8 weeks. If there is evidence of antitumor effect at 8 weeks, dosing may continue for up 2 two years.
All doses are taken orally. There are three levels of dosing, including a starting dose and two lower levels of dosing. Participants will start with the starting dose, and in the event of the dose limiting toxicities, the dose will be reduced as described below.
Starting Dose Level: 30 mg twice daily (Loading Dose) or 20 mg once daily (Continuous Dose) Dose Level -1: 15 mg twice daily (Loading Dose) or 10 mg once daily (Continuous Dose) Dose Level -2: 15 mg once daily (Loading Dose) or 5 mg once daily (Continuous Dose)
Stereotactic radiosurgeryRadiation
Patients will undergo standard of care SRS as per the treating facility's policies.
CorticosteroidDrug
Also called dexamethasone, methylprednisolone
Two corticosteroid regimens are used depending on the study cohort. Cohorts 1 and 2 will receive the loading dose (LD). Only Cohort 1 will receive the corticosteroid taper (CT).
LD: Oral (8 mg) or IV bolus dose (10 mg) of dexamethasone or 40 to 80 mg of methylprednisolone on the day of SRS CT: Oral 2-4 mg of dexamethasone twice daily for 5 days and then 2-4 mg daily for 5 days at the discretion of the treating physician (concurrent use of a proton pump inhibitor or H2 receptor antagonists are encouraged during the CT).
| Study group | Role | What they receive |
|---|---|---|
| Azeliragon and Stereotactic Radiosurgery (SRS) | Experimental | In the Phase 1 portion of the study, three treatment regimens will be systematically evaluated:
1. Azeliragon + SRS + loading corticosteroid dose (LD) + corticosteroid taper (CT)
2. Azeliragon + SRS + loading corticosteroid dose (LD)
3. Azeliragon + SRS
The starting cohort will receive Regimen #2, and depending on the tolerability, participants will be allocated to subsequent cohorts as follows: if Regimen #2 is not well tolerated, participants will be allocated to Regimen #1; if #2 is well tolerated, participants will be allocated to Regimen #3.
Once a Regimen has been identified as safe and tolerable, it will be used for the Phase 2 portion of the study. Receives: Drug: Azeliragon; Radiation: Stereotactic radiosurgery; Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Dose-Limiting Toxicities (DLTs)
A DLT of the azeliragon and corticosteroid regimen is defined as any central nervous system (CNS)-specific Grade ≥ 2 toxicity requiring corticosteroid treatment or any Grade ≥ 3 events that are not clearly due to the underlying disease or extraneous causes. DLTs will be considered up to four weeks after SRS.
Measured: 4 weeks
Secondary outcomes (10)
CNS treatment-related adverse events
Participants are evaluated for treatment-related adverse events (AEs). The total count of treatment-related AEs for all participants and those specifically in the central nervous system will be calculated. CNS treatment-related adverse events will be reported as percent of total treatment-related AEs.
Measured: 24 months
Early brain metastases response rate
Response and progression will be evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis (RANO-BM). The percent of patients with a complete response (CR) or partial response (PR) will be categorized individually and then together will be used to compare to the historical comparator of 24% with SRS alone.
Measured: 8 weeks
Intracranial objective response rate
Response and progression will be evaluated using RANO-BM. The percent of patients with CR, PR, or stable disease (SD) will be calculated.
Measured: 6 months
Intracranial objective response rate
Response and progression will be evaluated using RANO-BM. The percent of patients with CR, PR, or SD will be calculated.
Measured: 12 months
Lesion-specific local tumor control rate
Local failure will be defined using the following criteria: For lesions measuring more than 5 mm in the baseline (volumetric) scan: At least 50% increase in the product of the two largest perpendicular diameters (compared to the smallest product measured for the same lesion). For lesions measuring 5 mm or less in the baseline (volumetric) scan: At least 100% increase in the product of the two largest perpendicular diameters (compared to the smallest product measured for the same lesion). Radiation necrosis will not be considered tumor progression.
Lesion-specific tumor control rate is defined as the percent of lesions that do not meet criteria for local failure as defined above.
Measured: 6 months
Lesion-specific local tumor control rate
Local failure will be defined using the following criteria: For lesions measuring more than 5 mm in the baseline (volumetric) scan: At least 50% increase in the product of the two largest perpendicular diameters (compared to the smallest product measured for the same lesion). For lesions measuring 5 mm or less in the baseline (volumetric) scan: At least 100% increase in the product of the two largest perpendicular diameters (compared to the smallest product measured for the same lesion). Radiation necrosis will not be considered tumor progression.
Lesion-specific tumor control rate is defined as the percent of lesions that do not meet criteria for local failure as defined above.
Measured: 12 months
Neurocognitive outcomes battery
The following tests are included:
- Hopkins Verbal Learning Test (HVLT)
- Controlled Oral Word Association Test (COWAT)
- Trail Making Test Part A
- Trail Making Test Part B
- Grooved Pegboard
HVLT raw scores are derived for Total Recall, Delayed Recall, and Retention (% retained). COWAT is measured by summing the number of acceptable words produced for three separate letters during one minute each. The trail making tests are measured by the time they take to complete. The grooved pegboard is scored by the amount of time it takes to place the pegs correctly in the pegboard. Higher scores on HVLT and COWAT and faster times on the trail making and pegboard indicate better neurocognitive function. All tests are then standardized based on published norms and transformed so that higher values represent improved cognition.
The endpoint is defined as a decline of greater than 1 standard deviation from baseline on at least 1 of the 5 neurocognitive tests.
Measured: 24 months
Change in patient-reported outcomes (PROs)
PROs will be assessed using the MD Anderson Symptom Inventory for brain tumors (MDASI-BT), a validated assessment in people with brain metastases. It is a 28-item questionnaire that includes 13 symptom severity items, 6 symptom interference items, and 9 brain-tumor specific symptom items. Experience of each item "in the last 24 hours" is rated on a 10-point Likert scale where a higher score indicates worse outcomes.
Ratings are averaged into several subscale scores: mean core symptom severity, mean brain tumor symptom severity, and mean interference. The change score from baseline to 24 months will be calculated by subtracting the 12-month overall score from the baseline overall score. Positive values indicate improved outcomes and negative values indicate worse outcomes.
Measured: Baseline to 24 months
Change in quality of life (QOL) using EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 consists of 30 items and measures an individual's functioning and symptoms for all cancer types. Questions are grouped into 5 multi-item functional scales; 3 multi-item symptom scales; a 2-item global health status scale; 5 single items assessing additional symptoms commonly reported by cancer patients, and 1 item on the financial impact of the disease.
Raw QLQ-C30 scores are transformed to standardized scores (0 to 100); a higher score represents a better level of functioning or a worse level of symptoms. A Summary Score is calculated from the mean of 13 of the 15 scales (excluding Global Quality of Life and Financial Impact scales). The symptom scales are reversed to obtain uniform direction of all scales.
The change score from baseline to 24 months will be calculated by subtracting the 24-month score from the baseline score. Negative values indicate improved QOL.
Measured: Baseline to 24 months
Change in QOL using EORTC QLQ-BN20
EORTC QLQ-BN 20 consists of 20 items and measures the functioning and symptoms of patients with intracranial malignant disease. Questions can be grouped into 3 multi-item functional scales (visual disorder, motor dysfunction, communication deficit), 7 single items (headaches, seizures, drowsiness, itchy skin, hair loss, weakness of legs and bladder control) and 1 multi-item scale on future uncertainty.
Scoring is on a scale of 0 to 80, with higher scores indicating worse symptoms. The change score from baseline to 24 months will be calculated by subtracting the 24-month score from the baseline score. Positive values indicate improved symptoms.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start17 Nov 2023
- Primary completion16 Mar 2027 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Miami Cancer Institute, Cantex Pharmaceuticals Inc.
- Responsible party
- Sponsor
- Investigators
- Minesh Mehta, M.D., Principal investigator, Miami Cancer Institute at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789589
- Sponsor's protocol ID
- 2022-KOT-002
- Acronym
- ADORATION
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Zhang L, Zhang IY, Liang J, Wang H, Ouyang M, Wu S, da Fonseca ACC, Weng L, Yamamoto Y, Yamamoto H, Natarajan R, Badie B. RAGE expression in tumor-associated macrophages promotes angiogenesis in glioma. Cancer Res. 2014 Dec 15;74(24):7285-7297. doi: 10.1158/0008-5472.CAN-14-1240. Epub 2014 Oct 17.
PubMed 25326491van Grinsven EE, Nagtegaal SHJ, Verhoeff JJC, van Zandvoort MJE. The Impact of Stereotactic or Whole Brain Radiotherapy on Neurocognitive Functioning in Adult Patients with Brain Metastases: A Systematic Review and Meta-Analysis. Oncol Res Treat. 2021;44(11):622-636. doi: 10.1159/000518848. Epub 2021 Sep 3.
PubMed 34482312Yang L, Liu Y, Wang Y, Li J, Liu N. Azeliragon ameliorates Alzheimer's disease via the Janus tyrosine kinase and signal transducer and activator of transcription signaling pathway. Clinics (Sao Paulo). 2021 Mar 8;76:e2348. doi: 10.6061/clinics/2021/e2348. eCollection 2021.
PubMed 33681944Davis HM, Essex AL, Valdez S, Deosthale PJ, Aref MW, Allen MR, Bonetto A, Plotkin LI. Short-term pharmacologic RAGE inhibition differentially affects bone and skeletal muscle in middle-aged mice. Bone. 2019 Jul;124:89-102. doi: 10.1016/j.bone.2019.04.012. Epub 2019 Apr 24.
PubMed 31028960Riuzzi F, Sorci G, Sagheddu R, Chiappalupi S, Salvadori L, Donato R. RAGE in the pathophysiology of skeletal muscle. J Cachexia Sarcopenia Muscle. 2018 Dec;9(7):1213-1234. doi: 10.1002/jcsm.12350. Epub 2018 Oct 18.
PubMed 30334619Chiappalupi S, Sorci G, Vukasinovic A, Salvadori L, Sagheddu R, Coletti D, Renga G, Romani L, Donato R, Riuzzi F. Targeting RAGE prevents muscle wasting and prolongs survival in cancer cachexia. J Cachexia Sarcopenia Muscle. 2020 Aug;11(4):929-946. doi: 10.1002/jcsm.12561. Epub 2020 Mar 11.
PubMed 32159297
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05789589
- Acronym / sponsor ID
- ADORATION / 2022-KOT-002
- Conditions
- Cancer, Metastasis, Metastatic Cancer, Brain Metastases, Brain Metastases, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Miami Cancer Institute, Cantex Pharmaceuticals Inc.
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azeliragon and Stereotactic Radiosurgery (SRS) | Experimental | Drug: Azeliragon, Radiation: Stereotactic radiosurgery, Drug: CorticosteroidIn the Phase 1 portion of the study, three treatment regimens will be systematically evaluated: 1. Azeliragon + SRS + loading corticosteroid dose (LD) + corticosteroid taper (CT) 2. Azeliragon + SRS + loading corticosteroid dose (LD) 3. Azeliragon + SRS The starting cohort will receive Regimen #2, and depending on the tolerability, participants will be allocated to subsequent cohorts as follows: if Regimen #2 is not well tolerated, participants will be allocated to Regimen #1; if #2 is well tolerated, participants will be allocated to Regimen #3. Once a Regimen has been identified as safe and tolerable, it will be used for the Phase 2 portion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzeliragonAlso: TTP488, PF-04494700Dosing will begin on Day 0 with the loading dose and continue daily through Day 7. Starting on Day 8, dosing will resume with the continuous dose until disease progression or 8 weeks. If there is evidence of antitumor effect at 8 weeks, dosing may continue for up 2 two years. All doses are taken orally. There are three levels of dosing, including a starting dose and two lower levels of dosing. Participants will start with the starting dose, and in the event of the dose limiting toxicities, the dose will be reduced as described below. Starting Dose Level: 30 mg twice daily (Loading Dose) or 20 mg once daily (Continuous Dose) Dose Level -1: 15 mg twice daily (Loading Dose) or 10 mg once daily (Continuous Dose) Dose Level -2: 15 mg once daily (Loading Dose) or 5 mg once daily (Continuous Dose) | Drug | Azeliragon and Stereotactic Radiosurgery (SRS) |
| Stereotactic radiosurgeryPatients will undergo standard of care SRS as per the treating facility's policies. | Radiation | Azeliragon and Stereotactic Radiosurgery (SRS) |
| CorticosteroidAlso: dexamethasone, methylprednisoloneTwo corticosteroid regimens are used depending on the study cohort. Cohorts 1 and 2 will receive the loading dose (LD). Only Cohort 1 will receive the corticosteroid taper (CT). LD: Oral (8 mg) or IV bolus dose (10 mg) of dexamethasone or 40 to 80 mg of methylprednisolone on the day of SRS CT: Oral 2-4 mg of dexamethasone twice daily for 5 days and then 2-4 mg daily for 5 days at the discretion of the treating physician (concurrent use of a proton pump inhibitor or H2 receptor antagonists are encouraged during the CT). | Drug | Azeliragon and Stereotactic Radiosurgery (SRS) |
Primary outcome
Total Dose-Limiting Toxicities (DLTs)
Time frame: 4 weeks
A DLT of the azeliragon and corticosteroid regimen is defined as any central nervous system (CNS)-specific Grade ≥ 2 toxicity requiring corticosteroid treatment or any Grade ≥ 3 events that are not clearly due to the underlying disease or extraneous causes. DLTs will be considered up to four weeks after SRS.
10 secondary outcomes
CNS treatment-related adverse events
Time frame: 24 months
Early brain metastases response rate
Time frame: 8 weeks
Intracranial objective response rate
Time frame: 6 months
Intracranial objective response rate
Time frame: 12 months
Lesion-specific local tumor control rate
Time frame: 6 months
Lesion-specific local tumor control rate
Time frame: 12 months
Neurocognitive outcomes battery
Time frame: 24 months
Change in patient-reported outcomes (PROs)
Time frame: Baseline to 24 months
Change in quality of life (QOL) using EORTC QLQ-C30
Time frame: Baseline to 24 months
Change in QOL using EORTC QLQ-BN20
Time frame: Baseline to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 25326491Chen X, Zhang L, Zhang IY, Liang J, Wang H, Ouyang M, Wu S, da Fonseca ACC, Weng L, Yamamoto Y, Yamamoto H, Natarajan R, Badie B. RAGE expression in tumor-associated macrophages promotes angiogenesis in glioma. Cancer Res. 2014 Dec 15;74(24):7285-7297. doi: 10.1158/0008-5472.CAN-14-1240. Epub 2014 Oct 17.
- Background: PubMed 34482312van Grinsven EE, Nagtegaal SHJ, Verhoeff JJC, van Zandvoort MJE. The Impact of Stereotactic or Whole Brain Radiotherapy on Neurocognitive Functioning in Adult Patients with Brain Metastases: A Systematic Review and Meta-Analysis. Oncol Res Treat. 2021;44(11):622-636. doi: 10.1159/000518848. Epub 2021 Sep 3.
- Background: PubMed 33681944Yang L, Liu Y, Wang Y, Li J, Liu N. Azeliragon ameliorates Alzheimer's disease via the Janus tyrosine kinase and signal transducer and activator of transcription signaling pathway. Clinics (Sao Paulo). 2021 Mar 8;76:e2348. doi: 10.6061/clinics/2021/e2348. eCollection 2021.
- Background: PubMed 31028960Davis HM, Essex AL, Valdez S, Deosthale PJ, Aref MW, Allen MR, Bonetto A, Plotkin LI. Short-term pharmacologic RAGE inhibition differentially affects bone and skeletal muscle in middle-aged mice. Bone. 2019 Jul;124:89-102. doi: 10.1016/j.bone.2019.04.012. Epub 2019 Apr 24.
- Background: PubMed 30334619Riuzzi F, Sorci G, Sagheddu R, Chiappalupi S, Salvadori L, Donato R. RAGE in the pathophysiology of skeletal muscle. J Cachexia Sarcopenia Muscle. 2018 Dec;9(7):1213-1234. doi: 10.1002/jcsm.12350. Epub 2018 Oct 18.
- Background: PubMed 32159297Chiappalupi S, Sorci G, Vukasinovic A, Salvadori L, Sagheddu R, Coletti D, Renga G, Romani L, Donato R, Riuzzi F. Targeting RAGE prevents muscle wasting and prolongs survival in cancer cachexia. J Cachexia Sarcopenia Muscle. 2020 Aug;11(4):929-946. doi: 10.1002/jcsm.12561. Epub 2020 Mar 11.
- Miami Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minesh Mehta, M.D. principal investigator
Miami Cancer Institute at Baptist Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Azeliragon, Stereotactic radiosurgery and Corticosteroid in people with Cancer and Metastasis, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Dose-Limiting Toxicities (DLTs) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05789589, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.