OCT is launching preparation activities for a multi-center phase I/II study in patients with myelosuppression caused by chemotherapy.
Myelosuppression is a process, under which the production of blood cells decreases. Normal blood contains many cells. These include white blood cells aimed at fighting infections and red blood cells, the function of which is to carry oxygen.
Myelosuppression is usually caused during cancer treatment, namely, chemotherapy. Many drugs used for chemotherapy may suppress the bone marrow for some time. X rays in therapy may also destroy. Myelosuppression can also be caused by cancer cells. Usually, the peak of myelosuppression occurs on day 7-14, and restoration – on day 21-28 after chemotherapy start.
The current study will be conducted in five groups of patients having neutropenia at a time of myelotoxic chemotherapy of breast cancer.
OCT have broad experience in oncology studies, among which there are several big breast cancer trials. OCT also conducted a study in severe neutropenia in women with breast cancer. There were 9 sites in Russia and 5 sites in Bulgaria. This multinational study involved Russia, Poland, Latvia, Romania, Serbia, Hungary and Bulgaria. OCT team enrolled 156 patients in 2 countries in 6 months versus 123 patients in 5 other countries.
OCT experience in turns into such good aspects for the current trial as selecting qualified and experienced sites for the study with high recruitment rates.
At the same time, early-stage studies (namely, phase I and phase I/II) are considered to be the most risky in terms of possible effects (both positive and negative), especially if speaking about oncology studies. Often, such studies are conducted for patients in cohorts: the first cohort take the medicinal product in one dose, then, in case of no serious adverse reactions, the second cohort take the medicine in a slightly higher dose, etc. Safety boards can be organized in such studies in order to evaluate the impact of the drug on a patient before moving forward. SAE and SUSAR events, if any, are thoroughly monitored, controlled and tracked during such trials.