Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma
Status:
Withdrawn
Trial end date:
2026-07-01
Target enrollment:
Participant gender:
Summary
This is a Phase I open labelled study to treat patients with metastatic pancreatic cancer
with combination therapy using standard of care first line therapy with gemcitabine and
nab-paclitaxel given days 1, 8, and 15 every 28 days, and proglumide. This is a phase 1 study
with 3+3 design, enrolling3-12 patients over 2 planned dose levels of proglumide(maximum 6
patients per dose level). Proglumide will be tested at the daily dose of 1200 mg orally (PO)
given as 400mg three times daily (TID) (dose level 1) or 1600 mg orally(PO) given as 800 mg
twice a day (BID) (dose level 2). All cycles are 28 days. Patients will be monitored for
safety and toxicity by laboratory blood testing and physical examinations.