OCT Clinical Trials in Central and Eastern Europe has completed patient recruitment for the EMA and FDA-controlled, randomized, multicenter clinical study by September 2012. There is total of 658 patients with recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who have been included at one of 62 investigative medical centers in Russia (35 sites), Ukraine (16 sites), Belarus (4 sites), Latvia (2 sites), Lithuania (2 sites), and Bulgaria (5 sites) within 3.5 years. The remaining population of patients (107 subjects) has been spread throughout other 8 European countries. The average enrolment rate at OCT sites was 0.7 patients per center per month, while the drop-out rate was 8%.
The experimental treatment (cytostatic agent) is compared in terms of efficacy and safety with the standard chemotherapy. The investigational product is given to the patients in higher dose than the comparator, which is based on the same agent, and needs no pre-treatment. The administration of the study drug is three times faster than the comparator and results in less hypersensitivity reactions. The mentioned advantages make quality of life of the patients reasonably higher.
Primary objectives of the study for regulatory submission in Europe and US are: demonstrating the non-inferiority of the experimental treatment and the control treatment in terms of the change in AUC based treatment Cav of a study maker relative to predose Cav of the marker; showing non-inferiority of the experimental treatment and the control treatment in terms of progression free survival (PFS) using CT scans according to Response Criteria in Solid Tumors, RECIST, as assessed by central review; demonstrating superiority of the experimental treatment over the control treatment in terms of the incidence and severity of hypersensitivity reactions.
The treatment period is equivalent to six months per patient. The follow-up period will be continued until approximately 80% of the patients have progressed, according to RECIST as assessed by central review of CT scans. Patients leaving the study for any reason will be followed until death has occurred and date of death will be collected in order to assess overall survival.
Within the study OCT has been providing an array of services including project management, project administration, regulatory, logistics, clinical monitoring, CRA training, audits, purchase of concomitant and comparator medications, and other clinical research services. The collaboration with the Sponsor resulted in repeat business - additional clinical trials have been outsourced to OCT.