Study Design and Participants
ascites, GnP, PDAC
BRAIN METASTASES, ASCITES
This was a single institution, phase Ib, open-label study conducted at Washington University in St Louis, MO, USA to evaluate the safety and tolerability of ulixertinib plus GnP for patients with untreated metastatic PDAC under institutional review board approval (IRB# 201601098). The trial comprised a dose de-escalation portion and an expansion cohort at the RP2D. All patients provided written informed consent, and the study was conducted in accordance with the Declaration of Helsinki. Eligible patients were at least 18 years old and had histologically proven untreated metastatic PDAC. Inclusion criteria required ECOG < 1 with normal bone marrow and organ function (absolute neutrophil count >1500/μL, platelets >10 000/μL, hemoglobin >9 gm/dL, total bilirubin <ULN, AST, and ALT <2.5 × ULN, creatinine <1.5 × ULN or GFR >50 mL/minutes, cardiac left ventricular ejection fraction >50% and QTc < 470 ms. Exclusion criteria included CNS or brain metastases, significant ascites requiring therapeutic paracentesis or gastrointestinal conditions that could impair absorption of ulixertinib or HIV positivity.