12.Apr.2016

OCT obtains approval for bioequivalence study in cancer patients

This is an open-label, randomized, replicative, 4-period crossover study to compare pharmacokinetics and bioequivalence of the investigational drug and the comparator in cancer patients.

This local registration study is planned to be conducted at 5 investigational sites with 26 patients to be enrolled. For this purpose, about 40 patients with gastro-intestinal cancer or breast cancer aged from 18 to 65 will be screened. The expected total duration of this clinical trial is about slightly more than one year, including screening, enrollment, and collection and management of clinical data. It is expected that a total duration of involvement of each subject in this study will be 28 days, including screening, treatment and follow-up periods.

Colorectal and breast cancers remain to be one of the most important and significant problems for global healthcare systems. In terms of incidence, colorectal cancer ranks fourth in frequency in men (after lung cancer, stomach cancer and prostate carcinoma) and third in women (after breast and cervical cancers). In recent years, colorectal cancer incidence and mortality rates have increased in Russia.

An active ingredient of the investigational drug has been used in treatment of oncological patients for over the last 10 years and has proved to be effective and safe. High effectiveness of this active substance and considerable costs of existing medications with this active ingredient make the state registration of a more commercially available similar medicinal product very important.

OCT provides a full-cycle service support for this project being responsible for the preparation of all medical documents, selection of investigational sites, enrollment of patients, and work with a bioanalytical lab, data management and preparation of a final report.

OCT has a strong clinical oncology experience and successfully conducted over 30 studies in this therapeutic area, including bioequivalence studies. Such wide experience enables us to provide our sponsors with the best market expertise and the highest quality of studies under strict time constraints.