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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule.
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States
RECRUITINGBoca Raton Regional Hospital, Lynn Cancer Institute
Boca Raton, Florida, United States
RECRUITINGWilliamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Recommended Phase 2 Dose
Assessment of the recommended phase 2 dose (RP2D) of azeliragon in patients with metastatic pancreatic cancer.
Time frame: 8 weeks
AE and SAE Frequency
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
Time frame: 8 weeks
Pain after treatment initiation
Pain as determined by Brief Pain Assessment at 2, 4, 6 and 8 weeks after initiation of treatment.
Time frame: 8 weeks
Average daily opioid consumption.
Change in average daily total opioid consumption (in mg of morphine equivalent doses) at Weeks 2, 4, 6, and 8.
Time frame: 8 weeks
Plasma CA19-9 levels
Change in plasma CA19-9 levels.
Time frame: 8 weeks
Disease Control
Disease control as indicated by Complete Response + Partial Response + Stable Disease at 2 months and longer as determined by RECIST criteria, provided CT or MRI scans were performed consistent with standard of care.
Time frame: 8 weeks
Overall survival
Measurement of time from first dose of azeliragon until death from any cause.
Time frame: 8 weeks
Change in Eastern Cooperative Oncology Group (ECOG) status.
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AHN Cancer Institute - Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGPrisma Health - Upstate
Greenville, South Carolina, United States
RECRUITINGTexas Oncology - Northeast Texas
Tyler, Texas, United States
RECRUITINGMeasurement of change in grading of patient status based on descriptions in the ECOG performance status scale. Grading scale has a minimum value of 0 and maximum value of 5, with 0 being the best outcome and 5 being the worst.
Time frame: 8 weeks
Serum albumin
Change from baseline in serum albumin concentration.
Time frame: 8 weeks
Body Weight
Change from baseline in body weight.
Time frame: 8 weeks