08.Apr.2013

OCT to provide "rescue" services

OCT has been delegated a rescue study in metastatic cancer  

Once again OCT was addressed by a Sponsor with an inquiry to rescue a clinical trial that has been started by another service provider who unfortunately has not performed to the expectations and requirements. This time it is a standard open label phase I clinical study to assess safety and pharmacokinetics of the investigational drug in patients with metastatic cancer and solid tumors.
The main objectives of the study are as follows:

  • To determine the patients’ tolerance to the drug and assign the maximal tolerated dose and the dose-limiting toxicity;
  • To define the main pharmacokinetic parameters in single and repeated administration in different doses;
  • To define the safety of the drug in single and repeated administration within the assumed therapeutic range.

The investigational drug is a recombinant fully human anti-VEGF monoclonal antibody. Monoclonal antibodies belong to a relatively new type of treatment. They are mostly used for the treatment of systemic disorders and oncology in the framework of the so-called target therapy.

A monoclonal antibody is a molecule that is created in a laboratory and developed in such a way it attaches to those cancer cells that are defective. Monoclonal antibodies imitate the naturally-produced antibodies – the ones that are produced by the immune system of a patient as a response to different invaders (germs, vaccines, etc.). MAb are usually administered intravenously. Those can be used as a monotherapy or in combination with other types of therapy (hormone, chemical, etc.)

OCT has an extensive experience in conducting trials of monoclonal antibodies and has been involved in several clinical studies with MAb, early as well as late stage, in Russia, Ukraine, Belarus, the Baltic States and Bulgaria.

Furthermore, the current study is not a novel challenge for OCT in the sense that we have a proven record of successful rescue studies. The main problems that other CROs may face while conducting a trial are slow enrollment rates in clinical sites and low quality of the services provided by the CRO. Slow enrollment is quite a usual issue for trials conducted in the US, where the clinical trial market is oversaturated. Therefore, today sponsors are starting to realize that Russia and Eastern Europe are the regions that are convenient and efficient to conduct clinical trials, since here we have a large pool of drug-naïve patients, taking into consideration that the disease prevalence is similar to other European countries, or even higher in some indicators.

The highly-qualified and skilled OCT clinical team can always quickly analyze the situation and work out options to improve it, and we are sure to successfully rescue the Sponsor’s study.