Safety of LNA-i-miR-221
LNA-i-miR-221, toxicity
ADVERSE EVENTS
The primary endpoint of this study was the safety of LNA-i-miR-221. During the study no clinically significant changes in vital signs (heart rate and blood pressure) from baseline were noted. Additionally, no clinically significant changes in physical examination or ECG findings from baseline were reported during the study. Patients’ Performance Status ECOG scores during the study remained within the range 0–2. Furthermore, no clinically significant changes from baseline were noted in safety laboratory findings during the study.Safety results are reported in Tables Overview of adverse eventsn = number of subjects, m = number of eventsPercentages are based on the number of subjects within each cohortListing of adverse events. Safety analysis setn = number of subjectspercetages are based on the number of subjects within each cohortAn additional primary aim of this study was to assess the MTD of LNA-i-miR-221 and the RP2D. To this end, patients were progressively enrolled into five dose-escalation cohorts. LNA-i-miR-221 was well tolerated at all dose levels, with no grade 3–4 dose-limiting toxicity (DLT) observed in any cohort.