A Phase I/II Open Label Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients Refractory to Prior Treatment of Metastatic Pancreatic Cancer
Cantex Pharmaceuticals
Summary
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient must have histologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas for which potential curative measures, such as resection of an isolated metastasis, are not available. 2. Patient should have previously been treated with a Gemcitabine/Abraxane or FOLFIRINOX- based regimen. 3. Toxicity from prior chemotherapy other than alopecia has recovered to Grade ≤ 1 (CTCAE 1.0) or are at baseline (such as stable G2 neuropathy). 4. Male or non-pregnant and non-lactating female and ≥ 18 to ≤ 80 years of age. 5. Patient has adequate biological pa…
Interventions
- DrugAzeliragon
Azeliragon is an orally administered inhibitor of Receptor for Advanced Glycation Endproducts (RAGE) which is formulated as a 5mg hard gelatin capsule.
Locations (6)
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California
- Boca Raton Regional Hospital, Lynn Cancer InstituteBoca Raton, Florida
- Williamette Valley Cancer Institute and Research CenterEugene, Oregon
- AHN Cancer Institute - Allegheny General HospitalPittsburgh, Pennsylvania
- Prisma Health - UpstateGreenville, South Carolina
- Texas Oncology - Northeast TexasTyler, Texas