The study was a phase I-IIa clinical study on the investigational anticancer drug in patients with advanced cancer. The design was a prospective, open label, single-armed, dose-finding phase I-IIa study.
In Russia only, breast cancer, lung cancer, gastric cancer, ovarian cancer, etc. take away more than 300,000 lives annually. By the time of the initiation of the Russian Federation, the study was already running in Sweden. The goal was to enroll 6-8 patients in ovarian cancer and the same number of subjects in breast cancer. Having vast experience in oncology studies and well-developed contact with the investigators, OCT has enrolled the needed number of patients at two sites within the period of 3.5 months. A total of 16 patients were enrolled in two sites as was projected in 3.5 months.
In the phase I part of the study, patients with solid tumors were participating. This was the part conducted in Sweden. In the phase IIa part, patients with breast or ovarian cancer took part; these patients were enrolled at sites in Russia under the management of OCT.
The primary objectives of the study were to define the recommended phase II doses and to confirm it as well as to investigate tumour responses. There were three treatment cycles in the study, and yet another three cycles for those patients, who had an objective response to the therapy and also tolerable toxicity. Tumour response was evaluated according to the RECIST criteria.
In this study, OCT was responsible for regulatory issues (including the collection of documents from the study sites, submission of documents for the clinical trial approval to the local regulatory authorities and local ethics committees, approval obtainment, etc.), logistics aspects (import of the investigational product, distribution of the product to the sites, etc.) monitoring activities at the study sites through the whole study as well as full local management of the trial in the sites.