Proglumide and Chemotherapy for Metastatic Pancreatic Cancer

Description

After the Lead-in study, in the Phase 2 portion, patients will be randomized 1:1 to standard of care chemotherapy using gemcitabine (GEM) and nab-paclitaxel (NAB-P) (GEM 1000 mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days) plus placebo or proglumide at the recommended phase 2 dose (RP2D) for proglumide determined in the Lead-in study. Patients will be monitored for safety and toxicity by laboratory blood testing, physical examinations, neurological check, and cardiac monitoring in the Lead-in study. Dosing of chemotherapy will be managed following USPI recommendations. If dose-related toxicity occurs with proglumide, the medication will be held until the AE resolves. Proglumide will then be re-administered at the prior lower dose.

A research tumor biopsy will be performed before starting therapy. Every 8 weeks radiographic imaging will be done for assess tumor burden according to Standard of Care (SOC). Blood work for safety analysis will be done at 2 weeks, then every 4 weeks, interim vital signs and history is done every 4 weeks. Radiographic imaging and CA19-9 tumor marker will be done every 8 weeks according to SOC. A repeat tumor biopsy will be done at week 8 only for research purposes to examine the tumor microenvironment. A blood sample for research Biomarkers will be collected before starting therapy and every 8 weeks. Patients will be treated for 24 weeks or until progression is documented, unacceptable toxicities develop, or treatment is no longer required