The aim of this study was to compare pharmacokinetics and pharmacodynamics of the biosimilar with those of the reference drug and to demonstrate its therapeutic efficacy.
A total of more than 120 subjects were screened and randomized in twelve investigational sites in Russia. The trial was divided into two enrollment stages; the first one included an interim analysis upon reaching the enrollment of 24 subjects, which was followed by the second stage of enrollment. OCT team also prepared the interim report alongside the ongoing enrollment process. A final report is currently prepared for submission.
As part of this project, OCT was responsible for medical writing, project management, monitoring, data management and biostatistics, pharmacovigilance, full regulatory support, most part of logistics-related activities, and working with a central laboratory.
OCT’s current clinical experience includes more than 50 oncology trials of different phases. Its longstanding expertise and close cooperation with investigational sites along with in-depth knowledge of this type of clinical trials provide for high enrollment rates and high quality of clinical data and performance.