This was an open-label phase I clinical study to determine the safety and pharmacokinetics of the investigation drug in patients with solid tumors initiated by a well-known Russian pharmaceutical company.
The investigational product was a recombinant, fully human monoclonal anti-VEGF antibody, IgG1.
The main objective of the current study was to access safety and pharmacokinetics of the investigational drug in patients with solid tumors in the estimated therapeutic range of dosages at single and multiple administration with increasing dose. The safety of the investigational drug was demonstrated in the expected therapeutic range of dosages by determining the maximum tolerated dose (MTD).
The investigational drug was being administrated intravenously in weekly doses, with stepwise increase in dose. The increase in dose would stop when the MTD was reached.
A patient who experienced at least one adverse event (AE) that was defined as DLT was replaced. If two or more patients experienced a DLT the dose level below the one at which the DLT has been observed were considered as MTD and was stated as the dose for further development of the drug.
Since this a dose-escalation study aiming to assess the dose for the further development of the investigational drug, no efficacy assessments is done during this trial except for a baseline CT/MRI taken to be used for the follow-up study.
The study of the safety and pharmacokinetics of the different doses of the investigational drug at single and multiple administration was necessary in order to use the investigational drug in the course of therapy in the subsequent phase II and phase III clinical trials.
Dose escalation design is often applied in oncology studies. OCT has serious experience in this therapeutic area, among others, – more than 40 studies in oncology including 10 trials in patients with breast cancer and other types of solid tumors have been conducted by OCT since 2005 when the company was founded.
For the current study, OCT has been providing full support starting with the preparation of the Study Essential Documents (Study Protocol, Investigator’s Brochure, study manuals, etc.), including full Project Management, clinical monitoring, Data Management and Statistics.
At the moment, OCT team of medical writers are working on the final study report for the competed clinical trial.