This is an open-label, multi-center, sequential groups, dose-escalation study of the IP in patients with metastatic or unresectable advanced solid malignancies or refractory lymphomas. The study will consist of 2 parts: a dose-escalation component with a standard “3+3” design, followed by a dose-expansion component once the maximum tolerated dose (MTD) has been determined.
The primary objective of the study is to determine the maximally tolerated dose and recommended Phase 2 dose of a new medicinal product when administered intravenously to patients with the described disease.
The secondary objectives are to: describe the dose-limiting toxicity and adverse event profile of the IP; to define its pharmacokinetic profile and to document any objective responses of the drug.
The study is currently being conducted in the USA and is now to be piloted in the Russian Federation. 15 patients will be screened and 10 randomized from 4 oncology centers in Russia. OCT plan to enroll the first patients into the study in June 2015, and expect the study last until March 2017.
According to World Health Organization statistics, more than 7.5 million people in the world die because of cancer each year. Despite important recent advances in the understanding and treatment of cancer, metastatic neoplasia arising in adults is still associated with significant degrees of morbidity and mortality. Cancer, therefore, remains both a major public health concern and a large unmet medical need requiring the continued development of novel therapies.
The IP is a member of the carbazole family of chemicals. The effect of carbazoles on cancer has been known for many years. The first carbazole anti-tumor agent, ellipticene, was developed in the 1960s, and since then, numerous other carbazole compounds have been shown to exhibit cytotoxicity. Carbazoles, in general, bind to DNA and function as intercalating agents, although some of them also bind to the minor groove of DNA. However, it is now known that this intercalation is only the first step in the anti-cancer action of carbazoles.
The novel drug belongs to a distinct structural class of carbazole compounds discovered by a globally renowned laboratory. The compound came out of research on the effects of various agents on the activity of the key cancer targets p53 and NF-κB. It has been selected based on its anti-tumor activity and pharmaceutical properties as a development candidate for the treatment of cancer.
OCT’s in-depth expertise in oncology includes the conduct of 54 studies, 60 percent of which were full-service projects. Several studies were successfully conducted in patients with Acute Myeloid Leukosis and T-cell Leukemia disease. OCT’s long established relationships with experienced sites will guarantee successful execution of the trial as well as company growth prospects for the future.
OCT will be responsible for the following scope of activities required for initialization and conduct of the Study: site selection, clinical monitoring, project management, warehousing. OCT is also providing regulatory activities (initial dossier preparation and submission to the RA and local ethics committees) and obtaining of export/import licenses.