Azeliragon for Glioblastoma

Recruiting at 7 trial locations

Overseen By Stephen G Marcus, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cantex Pharmaceuticals

Must not be taking: CYP 2C8 inhibitors

Disqualifiers: Prior invasive malignancy, Recurrent disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a pill called azeliragon along with radiation therapy for a fast-growing brain cancer called 'unmethylated' glioblastoma. This type of cancer doesn't respond well to standard chemotherapy. The pill might help radiation work better and slow down the cancer's growth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are taking CYP 2C8 inhibitors. It's best to discuss your specific medications with the trial team.

Research Team

Stephen G Marcus, MD

Principal Investigator

Cantex Pharmaceuticals

Eligibility Criteria

Adults with a specific brain cancer called glioblastoma that hasn't spread, who haven't had certain other cancers or treatments, and whose major organs are functioning well. They must have had surgery for tumor removal but not just a needle biopsy. Participants need to be able to follow the study plan and agree to use birth control if they can have children.

Inclusion Criteria

I have fully recovered from any surgery or its complications before joining the study.

My diagnosis is IDH-wildtype glioblastoma, WHO grade 4.

Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities (legally authorized representative permitted)

Exclusion Criteria

Patients with any condition (e.g., psychological, geographical, etc.) that does not permit compliance with the protocol

I do not have a serious infection or health condition that would stop me from following the study treatment.

I have a stomach or intestine condition that affects my eating or digestion.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Treatment

Participants receive daily oral azeliragon in combination with radiation therapy

6-8 weeks

Daily visits for radiation therapy

Continued Treatment

Continued administration of azeliragon after completion of radiation therapy

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• Azeliragon

Trial Overview The trial is testing Azeliragon combined with radiation therapy as an initial treatment for glioblastoma without MGMT promoter methylation. It's in phase 2, which means it's checking safety and how well it might work after showing promise in earlier research.

Participant Groups

Group I: Daily oral azeliragon Experimental Treatment 1 Intervention

Azeliragon to be administered once daily for several days before, during, and after radiation therapy.

Who Is Running the Clinical Trial?

Cantex Pharmaceuticals

Lead Sponsor

Trials

14

Recruited

390+

Medpace, Inc.

Industry Sponsor

Trials

98

Recruited

30,400+

Dr. August J. Troendle

Medpace, Inc.

Chief Executive Officer since 1992

MD from the University of Maryland, School of Medicine; MBA from Boston University

Dr. Reinilde Heyrman

Medpace, Inc.

Chief Medical Officer since 2017

MD