Procedures
toxicity, tumor
ADVERSE EVENT, TUMOR
In the dose de-escalation phase, patients first received a 2-week lead-in of ulixertinib monotherapy according to a modified Fibonacci design with 3 decreasing dose levels (600 mg, 450 mg and 300 mg BID, at least one hour before food or 2 hours after food) to determine the RP2D. Patients experiencing excessive toxicity during the lead-in were replaced and were not to be considered evaluable for further toxicity assessment with combination treatment. Adverse events including severity and relationship to treatment were tabulated. Pre- and on-treatment tumor biopsies were performed during this period. After the 2-week ulixertinib lead-in, gemcitabine and nab-paclitaxel starting at 1000 mg/m