Enrollment
pneumonitis, nausea, fatigue, anemia, dehydration
DEHYDRATION, PNEUMONITIS, ANEMIA
Between August 2016 to January 2019, a total of 24 patients were screened and 18 patients were enrolled and treated on study (Baseline characteristics of all enrolled patients.(Dose expansion phase began in April 2018 and was halted after 2 patients were enrolled. One patient was hospitalized for anemia and pneumonitis attributed to gemcitabine during cycle 2 of the triplet combination, and later died. The other patient withdrew from the study due to treatment-related fatigue, nausea, and dehydration during cycle 1. Due to these concerns, after an internal review, RP2D of ulixertinib was adjusted to 450 mg BID in combination with GnP. Six additional patients were then treated. However, these patients were unable to complete 2 cycles of treatment due to clinical progression (