Clinical trial NCT05789589: Effect of Azeliragon Combined With Stereotactic Radiation Therapy in Patients With Brain Metastases
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
Conditions: Cancer
Metastasis
Metastatic Cancer
Brain Metastases
Brain Metastases, Adult
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).
Interventions:
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.<br/>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.<br/>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)
name: Azeliragon
other_name: PF-04494700
TTP488
type: Drug
description: Patients will undergo standard of care SRS as per the treating facility's policies.
name: Stereotactic radiosurgery
type: Radiation
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).<br/>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).
name: Corticosteroid
other_name: dexamethasone
methylprednisolone
type: Drug
Study arms:
design_group_description: In the Phase 1 portion of the study, three treatment regimens will be systematically evaluated:<br/>1. Azeliragon + SRS + loading corticosteroid dose (LD) + corticosteroid taper (CT)<br/>2. Azeliragon + SRS + loading corticosteroid dose (LD)<br/>3. Azeliragon + SRS<br/>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.<br/>Once a Regimen has been identified as safe and tolerable, it will be used for the Phase 2 portion of the study.
design_group_title: Azeliragon and Stereotactic Radiosurgery (SRS)
design_group_type: Experimental
Sponsor: Baptist Health South Florida, Inc.
Collaborators: Miami Cancer Institute, Inc.
Cantex Pharmaceuticals, Inc.
Drug name mappings:
name: Azeliragon
lang: EN