11.Aug.2015

OCT applies for approval of a phase III multinational clinical trial in breast cancer patients

OCT applies for approval of a phase III multinational clinical trial of a drug aimed at treating breast cancer patients

We are happy to announce that OCT has applied to the Ministry of Healthcare of the Russian Federation for approval of phase III multinational clinical trial of a drug aimed at treating patients with locally advanced or metastatic breast cancer after failure of previous anthracycline-containing chemotherapy.

This is a prospective, multinational, multicenter, open-label, third party-blinded, randomized, active-controlled, parallel-group study conducted in order to compare the antitumor effect and safety of the study drug and the comparator drug. Both drugs have the same route of administration (intravenous infusion, for 6 cycles).

The clinical trial is expected to be conducted in Latvia, Ukraine and Russia. In this study a total of 235 subjects will be screened to achieve the target enrollment number of 200 subjects which will be randomized into two arms with 1:1 allocation ratio (100 patients in each arm).

A total of 9 investigational sites are expected to screen 105 subjects in order to randomize 90 patients. The study is expected to be initiated on 1 October 2015 and to be completed by 30 June 2017.

According to the World Health Organization, from 800 thousand to 1 million of new cases of breast cancer are reported annually. This type of cancer is the second leading cause of cancer deaths in women. In Russia, as of 2010, breast cancer had the highest rates of malignant neoplasms both in morbidity (20.5 %) and mortality (17.2 %) in women; apart from that, the number of newly diagnosed cases of breast cancer has increased to 57,241. Cancer remains to be a significant public health problem requiring continuous development of new anti-tumor drugs to address unmet medical needs in this life-threatening disease.

This is a full-service clinical project in which OCT will provide full regulatory and investigational support including site selection, medical writing, performance of all necessary regulatory activities, making submissions to local ethics committees, execution of CTAs with investigational sites and principal investigators, as well as all activities related to project management, development of project plans, monitoring, logistics, data management and statistics.

OCT’s in-depth expertise in clinical study conduct includes more than 50 trials of various phases and therapeutic areas most of which were full-service projects. The company have already had a successful experience of more than a dozen of clinical studies in patients with breast cancer. All this contributes to a successful selection of trial sites capable of providing fast recruitment and high quality of the research.