Assessment and monitoring
tumor
ADVERSE EVENTS, TUMOR
The study began with a screening visit. Mandatory tumor assessment via computed tomography (CT) scan imaging was performed at enrolment and at cycle completion. Follow-up imaging was performed for evaluation of responses or clinical benefit. We selected to systematically perform CTscan for uniform clean data interpretation. CT assessment was performed on the 30th ± 1 day, as reported on V.E.S. (Visit Evaluation Schedule), except for patients belonging to the 1st cohort, whose CT evaluation was carried on 56th ± 1 day (the cohort has been completed before trial amendment). Patients returned to the clinic within 7 days from the baseline visit to receive the first infusion of LNA-i-miR-221 (day 1). Patients were admitted to the Phase I Center in-patients ward during days 1–4 due to the daily infusion of LNA-i-miR-221, the need of intensive monitoring, and the requirement of post-infusion blood and urine sampling.Patients returned to the clinic at day 6, 8, 15, and 22 for clinical evaluation and blood collection. Final assessment and safety follow-up was performed on day 30 ± 1. At the same day, CT scan imaging was performed. Patients were scheduled for subsequent monthly visits. Imaging data were assessed according to the RECIST 1.1 criteria (version 2009) to determine anti-tumor activity. At each visit patient’s concomitant medications and adverse events (AEs) were registered.