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Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases (ADORATION)

Primary Purpose

Cancer, Metastasis, Metastatic Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Azeliragon
Stereotactic radiosurgery
Corticosteroid
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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 × 109/L Platelet count ≥ 75,000/mm3 (75 × 109/L) Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; Platelet count ≥ 75,000/mm3 (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) 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

Sites / Locations

  • Miami Cancer Institute at Baptist Health, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Azeliragon and Stereotactic Radiosurgery (SRS)

Arm Description

In the Phase 1 portion of the study, three treatment regimens will be systematically evaluated: Azeliragon + SRS + loading corticosteroid dose (LD) + corticosteroid taper (CT) Azeliragon + SRS + loading corticosteroid dose (LD) 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 16, 2023
Last Updated
October 5, 2023
Sponsor
Baptist Health South Florida
Collaborators
Miami Cancer Institute, Cantex Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05789589
Brief Title
Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases
Acronym
ADORATION
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
Collaborators
Miami Cancer Institute, Cantex Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Metastasis, Metastatic Cancer, Brain Metastases, Brain Metastases, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azeliragon and Stereotactic Radiosurgery (SRS)
Arm Type
Experimental
Arm Description
In the Phase 1 portion of the study, three treatment regimens will be systematically evaluated: Azeliragon + SRS + loading corticosteroid dose (LD) + corticosteroid taper (CT) Azeliragon + SRS + loading corticosteroid dose (LD) 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.
Intervention Type
Drug
Intervention Name(s)
Azeliragon
Other Intervention Name(s)
TTP488, PF-04494700
Intervention Description
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)
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiosurgery
Intervention Description
Patients will undergo standard of care SRS as per the treating facility's policies.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
dexamethasone, methylprednisolone
Intervention Description
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).
Primary Outcome Measure Information:
Title
Total Dose-Limiting Toxicities (DLTs)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
CNS treatment-related adverse events
Description
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.
Time Frame
24 months
Title
Early brain metastases response rate
Description
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.
Time Frame
8 weeks
Title
Intracranial objective response rate
Description
Response and progression will be evaluated using RANO-BM. The percent of patients with CR, PR, or stable disease (SD) will be calculated.
Time Frame
6 months
Title
Intracranial objective response rate
Description
Response and progression will be evaluated using RANO-BM. The percent of patients with CR, PR, or SD will be calculated.
Time Frame
12 months
Title
Lesion-specific local tumor control rate
Description
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.
Time Frame
6 months
Title
Lesion-specific local tumor control rate
Description
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.
Time Frame
12 months
Title
Neurocognitive outcomes battery
Description
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.
Time Frame
24 months
Title
Change in patient-reported outcomes (PROs)
Description
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.
Time Frame
Baseline to 24 months
Title
Change in quality of life (QOL) using EORTC QLQ-C30
Description
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.
Time Frame
Baseline to 24 months
Title
Change in QOL using EORTC QLQ-BN20
Description
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.
Time Frame
Baseline to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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 × 109/L Platelet count ≥ 75,000/mm3 (75 × 109/L) Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; Platelet count ≥ 75,000/mm3 (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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupesh Kotecha, M.D.
Phone
(786) 596-2000
Email
rupeshk@baptisthealth.net
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Carolina Avendaño
Phone
(786) 527-8863
Email
mariaave@baptisthealth.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, M.D.
Organizational Affiliation
Miami Cancer Institute at Baptist Health, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yazmin Odia, M.D.
Organizational Affiliation
Miami Cancer Institute at Baptist Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Cancer Institute at Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, M.D.
Phone
786-596-2000
Email
rupeshk@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Maria Carolina Avendaño
Phone
(786) 527-8863
Email
mariaave@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Rupesh Kotecha, M.D.
First Name & Middle Initial & Last Name & Degree
Yazmin Odia, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25326491
Citation
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.
Results Reference
background
PubMed Identifier
34482312
Citation
van 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.
Results Reference
background
PubMed Identifier
33681944
Citation
Yang 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.
Results Reference
background
PubMed Identifier
31028960
Citation
Davis 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.
Results Reference
background
PubMed Identifier
30334619
Citation
Riuzzi 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.
Results Reference
background
PubMed Identifier
32159297
Citation
Chiappalupi 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.
Results Reference
background
Links:
URL
http://cancer.baptisthealth.net/
Description
Miami Cancer Institute

Learn more about this trial

Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases

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