Phase 1 Study of Gemcitabine and Nab-paclitaxel With or Without Pitavastatin for Maintenance Treatment of Unresectable Pancreatic Cancer

What this Trial Is About

Researchers are conducting a phase 1, open-label clinical trial to find the recommended dose for phase 2 of Gemcitabine combined with Nab-paclitaxel, with or without Pitavastatin, in people with unresectable pancreatic adenocarcinoma. This trial focuses on individuals who are already receiving Gemcitabine treatment for their disease. The trial is led by the University of California, Irvine, and aims to understand the best dosing to move forward in treatment development. Participants receive Pitavastatin orally once daily on days 1-28 of each 4-week cycle, alongside their ongoing Gemcitabine and Nab-paclitaxel treatment. The study includes three dosing levels of Pitavastatin 1 mg, 2 mg, and 4 mg. The trial is non-randomized and open-label, meaning all participants know which dose they receive. This dosing schedule helps researchers assess safety and optimal dosing for future studies. During the trial, participants will undergo various assessments including monitoring for adverse events, evaluating tumor response using RECIST 1.1 criteria, and tracking progression-free survival over two years. Researchers will also collect lab tests and physical exams to check organ function and overall health. The main goal is to determine the recommended dose for phase 2 while ensuring participant safety throughout the study period, which may last up to two years.

PhIbRandomGemcitabine(G)w/or w/Out Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)