RECRUITING

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

Talk to us

Conditions

CancerMetastasisMetastatic CancerBrain MetastasesBrain Metastases, Adult

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-11-17
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05789589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Age ≥ 18
  3. 3. Karnofsky performance status ≥ 50 or Eastern Cooperative Oncology Group (ECOG) ≤ 3
  4. 4. Brain metastasis with a maximum tumor diameter of the largest lesion ≤ 2 cm
  5. 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. 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. 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. 8. Patient has adequate biological parameters as demonstrated by the following blood counts at Screening (obtained ≤ 14 days prior to enrollment):
  9. * Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L
  10. * Platelet count ≥ 75,000/mm\^3 (75 × 10\^9/L)
  11. * Hemoglobin (Hgb) ≥ 9 g/dL without transfusion or growth factor support
  12. 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
  13. 10. Patient has the following blood chemistry levels at Screening (obtained ≤ 14 days prior to enrollment):
  14. * Aspartate aminotransferase (AST; SGOT), alanine transaminase (ALT; SGPT) ≤ 2.5 × upper limit of normal range (ULN). Total bilirubin ≤ 1.5 × ULN.
  15. * Estimated creatinine clearance of \> 60 mL/min (per Cockcroft-Gault formula)
  1. 1. Patients with leptomeningeal disease
  2. 2. Patients unable to undergo magnetic resonance imaging (MRI)
  3. 3. Patients receiving Cytochrome P450 (CYP) 2C8 inhibitors as indicated in the protocol
  4. 4. Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
  5. 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. 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. 7. Any patient that in the opinion of the principal investigator is not an appropriate candidate for this trial

Contacts and Locations

Study Contact

Minesh Mehta, M.D.
CONTACT
(786) 596-2000
mineshm@baptisthealth.net
Antoinette M Pimentel
CONTACT
(786) 596-2000
antoinette.pimentel@baptisthealth.net

Principal Investigator

Minesh Mehta, M.D.
PRINCIPAL_INVESTIGATOR
Miami Cancer Institute at Baptist Health, Inc.
Yazmin Odia, M.D.
PRINCIPAL_INVESTIGATOR
Miami Cancer Institute at Baptist Health, Inc.

Study Locations (Sites)

Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

  • Minesh Mehta, M.D., PRINCIPAL_INVESTIGATOR, Miami Cancer Institute at Baptist Health, Inc.
  • Yazmin Odia, M.D., PRINCIPAL_INVESTIGATOR, Miami Cancer Institute at Baptist Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17
Study Completion Date2027-08

Study Record Updates

Study Start Date2023-11-17
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer
  • Metastasis
  • Metastatic Cancer
  • Brain Metastases
  • Brain Metastases, Adult