06.Mar.2012

Central ethics approval for phase Ib trial in solid tumors received

The multiple dose escalation study is being initiated at four sites in 48 patients with advanced solid tumors. The subjects participating in the study are patients with advanced solid tumors that are resistant to standard care treatment.

The multiple dose escalation study is being initiated at four sites in 48 patients with advanced solid tumors. The subjects participating in the study are patients with advanced solid tumors that are resistant to standard care treatment.

In clinical trials, patients, who failed in response to SoC therapy, receive a possibility to have an access to new treatments that can bring pain relief and state improvement. A complex indication brings about associated difficult issues to resolve – for instance, ethical aspects. Those are resolved during the review of the submitted clinical trial documents by the Ethics Council of the Russian Federation under the Ministry of Health and Social Development of the Russian Federation. Moreover, before designing the documents for an oncology clinical trial, medical writers usually also consult investigators as to how many therapy cycles should be run, which concomitant medication can be used, etc. Based on the established ethical norms and previous experience, OCT has checked all the documents for compliance with the requirements. The ethics approval has been granted. From now on, enrollment into the study at the selected sites in Russia will start.

The medicinal drug is based on the technology which enables to avoid DNA affection. Moreover, these agents are not mutafacient neither genotoxic. Previous studies of the drug including pre-clinical studies have already pointed to its likely impressive effectiveness.

OCT team would be interested to be involved in further development investigational studies of this medicinal product. OCT huge experience in oncology studies will enable the team to propose adequate further designs and services for the trials.