Phase I trial enrollment completed

This is an open-label, multicenter, non-randomized phase I study in oncological patients.

This clinical study is aimed to assess the safety, acceptability, toxicity and pharmacokinetics of the investigational drug which is intended to be used for preparation of emulsions for infusions. The study is designed to determine the maximum tolerated dose.

Patients were successively enrolled into cohorts starting from the cohort with the lowest investigated dose level. 30 patients were planned to take part in the study. In order to account for screening dropouts, 35 patients were expected to be enrolled (men and women, 18 to 75 years of age). The duration of participation in the study for each patient will not exceed 36 days.

The whole study period will last for about 11 months. 

Breast cancer is the most common oncological disease in many countries. In developed countries breast cancer is the most common type of cancer (26% of all cases of cancer) and the leading cause of cancer death among women. Since 1990, the incidence of breast cancer is increasing annually by 1.5%. In Russia breast cancer ranks first among all malignant neoplasms in women since 1985 and is accounted for 19.8% of all cancer cases since 2004 with the growth rate of 35.6% over 10 years.

In this project OCT provides a full range of services related to the organization and conduct of the study, except for regulatory support.

The OCT team is well aware of all challenges associated with breast cancer trials. Our company has successfully completed more than 15 studies in this indication. Oncological research projects make up a considerable part of all the studies conducted by OCT. The company’s portfolio also includes infectious and respiratory diseases, cardiology, surgery, rheumatology, etc. To learn more about our experience in phase I-IV and BE studies, please follow this link.