07.Aug.2017

Approval obtained for a phase I study in patients with blood сancers

This is an open-label clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of an investigational drug.

The drug will be evaluated in subjects with previously treated hematological malignancies.

Cancer remains a continuing public health concern of major proportions. Among the many types of blood cancers, B-cell lymphoid malignancies arise from the accumulation of monoclonal neoplastic Blymphocytes in lymph nodes and often in blood, bone marrow, spleen, and liver. Front-line combination therapies can be effective in providing durable remissions. However, most patients eventually experience disease relapse. Despite the use of agents with differing mechanisms of action, progressive resistance to treatment develops. Novel mechanisms of action are needed to offer additional treatment options for patients with blood cancers who have experienced disease progression.

This is supposed to be a group sequential, dose escalation, and cohort expansion trial. Beyond assessing the ability of the study drug to control the tumor growth, tumor assessments will also be considered in defining the proper duration of treatment for each study participant. The first part of the study is planned to include up to 50 patients. 

In this project, OCT is responsible for preparing and submitting the package of documents required to obtain a study approval, for interaction with regulatory authorities, sites selection, and qualification visits.