01.Sep.2015

OCT to apply to the Ministry of Healthcare for approval of a bioequivalence study of the investigational drug in cancer patients

OCT to apply to the Ministry of Healthcare for approval of a bioequivalence study of the investigational drug in cancer patients

We are happy to announce that OCT is going to submit an application to the Ministry of Healthcare of the Russian Federation for approval of a bioequivalence study of the investigational drug aimed at treating patients with cancer disease. This is an open-label, randomized, replicative, cross-over 4-period study to compare pharmacokinetics and bioequivalence of the investigational product and reference drug in cancer disease patients.

The investigational drug is a generic of a well-known reference medicinal product. The active substance of the investigational drug is a fluoropyrimidine carbamate derivative, orally administered cytostatic agent. As a result of selective activation, which takes place following dose administration, 5-FU concentration in the tumor tissue becomes significantly greater than that in plasma and normal tissues. This results in effective local cytostatic action and minimization of systemic toxic effects of the drug. The investigational product has successfully been applied both as a single agent and in combination in the treatment of breast cancer and colorectal cancer.

In comparison with other available high cost generic products, the study drug represents a more affordable and accessible treatment option for cancer patients, primarily due to its effectiveness.

The basis for the current study aimed at assessing the comparative pharmacokinetics and bioequivalence of the investigational drug were the similarity of safety values of the study and reference drugs identified in pre-clinical studies along with the combination of its high efficacy and a favorable safety profile. This study is open, randomized, replicative, cross-over 4-period comparative study.

The clinical trial is expected to be conducted in 7 clinical sites in Russia. A total of 26 patients are going to be randomized in the study. By taking into account the possibility of early discontinuation of some participants during the treatment period, we also make provision for 4 additional back-up subjects to be able to replace the withdrawn patients, if needed. In order to mitigate the risk of screen-failures, about 42 patients are expected to be screened into the study.

The study is expected to be initiated on October 1, 2015 and to be completed by July 31, 2016. Patient recruitment is expected to be completed by October 2016.The subjects will be randomized into two arms (1 or 2) with 1:1 allocation ratio. Patients will be receiving study medication as a single cycle during the treatment period. Expected duration of the subject’s participation in the study will be 28 days maximum (including screening, treatment and follow-up periods).

This is a full-service clinical project in which OCT will provide full regulatory and investigational support, including site selection, medical writing, regulatory assistance, 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, import license obtaining, data management and statistics.

OCT’s in-depth expertise in oncology studies includes more than 50 trials of various phases and therapeutic areas with more than a dozen of successful bioequivalence studies. All this guarantees fast recruitment rates and high quality of clinical trials for our clients.