Study of Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cantex Pharmaceuticals
Study ID
NCT05766748
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Azeliragon — DRUG
    Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule.

Study Details

This is an open label study to determine the safety and preliminary evidence of a therapeutic effect of azeliragon in patients refractory to prior treatment of metastatic pancreatic cancer.

Key Dates

Start date
Jun 1, 2023
Status verified
Jun 2024
Primary completion
Feb 28, 2025
Completion
May 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    Azeliragon will be orally administered to 5 groups of 6 subjects, with escalation of dosing occurring with each subsequent group. Dose Level 1 is a loading dose of 15mg once daily for 6 days, followed by a dose of 5mg once daily for the rest of the study. Dose Level 2 is a loading dose of 15mg twice daily for 6 days, followed by a dose of 10mg once daily for the rest of the study. Dose Level 3 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 20mg once daily for the rest of the study. Dose Level 4 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 15mg twice daily for the rest of the study. Dose Level 5 is a loading dose of 30mg twice daily for 6 days, followed by a dose of 25mg twice daily for the rest of the study. Escalation will continue until stopping rules are met or the highest defined dose level is reached. The trial will be closed to accrual if the first dose level is deemed intolerable.

Primary Outcome Measure

Recommended Phase 2 Dose [ Time Frame: 8 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048
Andrew Hendifar, MD
[email protected]
310-423-2217
Boca Raton Regional Hospital, Lynn Cancer InstituteBoca RatonFlorida33486
Warren Brenner, MD
[email protected]
561-955-6400
Williamette Valley Cancer Institute and Research CenterEugeneOregon97401
Marc Uemura, MD
[email protected]
541-683-5001
AHN Cancer Institute - Allegheny General HospitalPittsburghPennsylvania15212
Nathan Bahary, MD
[email protected]
412-359-6391
Prisma Health - UpstateGreenvilleSouth Carolina29605
Ki Chung, MD
[email protected]
864-455-3600
Texas Oncology - Northeast TexasTylerTexas75702
Donald Richards, MD
[email protected]
903-579-9800

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CABoca Raton Regional Hospital, Lynn Cancer Institute· Boca Raton, FLWilliamette Valley Cancer Institute and Research Center· Eugene, ORAHN Cancer Institute - Allegheny General Hospital· Pittsburgh, PAPrisma Health - Upstate· Greenville, SCTexas Oncology - Northeast Texas· Tyler, TX

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