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Azeliragon + Radiation for Brain Cancer (ADORATION Trial)
Phase 1 & 2
Recruiting
Led By Rupesh Kotecha, 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
ADORATION Trial 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.Check my eligibility
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.See study design
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.
ADORATION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
CNS treatment-related adverse events
Change in QOL using EORTC QLQ-BN20
Change in patient-reported outcomes (PROs)
+5 moreADORATION 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:
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.
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
Find a Location
Who is running the clinical trial?
Cantex Pharmaceuticals Inc.UNKNOWN
Baptist Health South FloridaLead Sponsor
48 Previous Clinical Trials
7,785 Total Patients Enrolled
Miami Cancer InstituteOTHER
5 Previous Clinical Trials
899 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding and will use effective birth control during and for 6 months after treatment.My cancer was confirmed by a doctor within the last 5 years, or I have recent proof it's still active.I have a stomach or intestine condition that affects my eating or digestion.I have cancer that has spread to the lining of my brain and spinal cord.I am 18 years old or older.I can take care of myself but may not be able to do any work.My largest brain tumor is 2 cm or smaller.I am willing to use effective birth control during and 6 months after the trial.I am taking medication that affects how my body processes drugs.I stopped taking corticosteroids 5 days before my scheduled SRS.I had brain radiation over 2 months ago and have new brain lesions not previously treated.My liver and kidney functions are within the required range for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Azeliragon and Stereotactic Radiosurgery (SRS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots available for potential participants in this research?
"According to clinicaltrials.gov, this particular medical trial is no longer recruiting participants. The study was initially uploaded on April 1st 2023 and last modified 16 days later on March 16th 2023. Although it has concluded recruitment, there are still 1515 other studies which are actively seeking candidates at this time in history."
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