Phase 1b pitavastatin HMG‑CoA reductase inhibitor plus gemcitabine/nab‑paclitaxel in uPDAC.

This Phase 1b, open-label, randomized maintenance study at University of California, Irvine tests whether adding pitavastatin (a small‑molecule HMG‑CoA reductase inhibitor that suppresses the mevalonate/cholesterol pathway) to ongoing gemcitabine + nab‑paclitaxel can be safely continued and helps control unresectable pancreatic ductal adenocarcinoma after initial disease stability. Participants have metastatic, recurrent, or unresectable PDAC and must have already received gemcitabine-based therapy for about 2 months without progression, with no more than 2 prior systemic lines. The intervention compares gemcitabine (a nucleoside analog that inhibits DNA synthesis) plus nab‑paclitaxel (albumin‑bound paclitaxel; a microtubule stabilizer/mitotic inhibitor) with versus without pitavastatin dosing daily in 28‑day cycles, aiming to define a recommended Phase 2 dose and generate early activity signals. The scientific angle is repurposing a widely used lipid drug to potentially modulate tumor cell signaling/membrane biology and improve chemo durability in a maintenance setting. Today’s care for unresectable/advanced PDAC is multi-agent first-line chemotherapy (often modified FOLFIRINOX or gemcitabine/nab‑paclitaxel), then sequential regimens and clinical trials when the cancer progresses.