March 2012 OCT started a comparative multicenter randomized two arm phase II clinical study to investigate the safety, tolerability and antitumor activity of the investigational drug versus a reference drug in metastatic breast cancer subjects. The aim of the trial was to compare progression-free survival of patients due to the treatment with the investigational drug, as well as to compare overall toxicity and time-to treatment response, with the same indicators values in patients receiving traditional therapy.
19 sites have been opened in Russia and the USA, 153 patients have been enrolled and randomized 4:3. According to the study design, arm-1 patients are treated with the investigational drug, while arm-2 subjects are receiving commercially available therapy. After several treatment cycles, patients from the second arm crossover to start getting treatment from arm-1, on the assumption of disease progress.
By now, 25 patients from the second arm have been transferred to the group under the investigational drug treatment, after the traditional drug had turned out to be ineffective. All the data concerning those 25 patients have been collected, cleansed and provided for statistical manipulation, which was commemorated as the first milestone achievement. Our clinical research associates keep collecting data from the rest of the second arm 40 patients.
With an in-house clinical data management (
OCT is eager to provide the whole range of services for your phase I to IV clinical trials, from initial consulting to data management support and statistical reports provision.