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Azeliragon + Radiation for Brain Cancer (ADORATION Trial)

Phase 1 & 2

Recruiting

Led By Minesh Mehta, M.D.

Research Sponsored by Baptist Health South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a drug and radiation combo would shrink brain tumors and keep them controlled for longer.

Who is the study for?

This trial is for adults with small brain tumors from cancer spread, who are not pregnant or breastfeeding and agree to use contraception. They should have a certain level of physical function, no recent steroids or other clinical trials, and meet specific blood count and chemistry levels.

What is being tested?

The study tests the safety and effectiveness of azeliragon in combination with focused radiation therapy (stereotactic radiosurgery) on patients with brain metastases to see if it can shrink tumors and control their growth better.

What are the potential side effects?

Potential side effects may include typical reactions from radiation like headaches, fatigue, hair loss at treatment site, nausea; plus any unknown risks associated with azeliragon which could affect organs processed by liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total Dose-Limiting Toxicities (DLTs)

Secondary study objectives

CNS treatment-related adverse events

Change in QOL using EORTC QLQ-BN20

Change in patient-reported outcomes (PROs)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Azeliragon and Stereotactic Radiosurgery (SRS)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Corticosteroid

2005

Completed Phase 4

~2210

Stereotactic radiosurgery

2015

Completed Phase 2

~180