Study treatment
LNA-i-miR-221
Patients were enrolled in five dose-escalating cohorts. The initial study protocol included daily intravenous (IV) infusions on day 1 to 4 followed by a 24-day wash-out, before a second treatment cycle on day 29 to 32. Following completion of the first cohort, the study protocol was amended to reduce the treatment plan to a single treatment course and ensure patients adherence to protocol. Individuals included from cohort II to cohort V underwent 4 days of LNA-i-miR-221 administration on day 1 to 4, followed by 24 days observation.LNA-i-miR-221 dose levels were determined using a modified Fibonacci 3 + 3 dose-escalation scheme with 3 patients enrolled in each cohort 