This is a phase II dose-escalation study exploring dose and treatment response of weekly administration of the investigational drug to patients with metastatic breast cancer.
The primary objective of the current study is to determine the dose for weekly administration of the investigational drug, while the secondary objective is to assess the safety of such weekly treatment.
According to the Study Protocol, 25 female patients with metastatic breast cancer were planned to be included in the trial. However, due to the dose-escalation study design, the number of patients has been increased during the study, and the total of 58 subjects have been enrolled with the strengths of 2 medical sites in Russia (41 patient) and 1 medical site in Latvia (17 patients).
The dose-escalating design of this clinical trial implicates that the investigational drug would be administrated intravenously in weekly doses, with stepwise increase in dose. The increase in dose would stop when maximum tolerated dose (MTD) is reached. Dose limiting toxicity (DLT) would be assessed during cycle 1 only although treatment would continue for a total of 4 cycles and safety information would be collected.
A patient who experience at least one adverse event (AE) that is defined as DLT is replaced. If two or more patients experience a DLT the dose level below the one at which the DLT is observed are considered as MTD and is stated as the dose for further development of the drug. It has been estimated that 4 dose-levels would have been explored, but the study stopped when MTD was been reached after 58 subjects have been enrolled.
Since this a dose-escalation study aiming to assess the dose for the further development of the investigational drug, no efficacy assessments is done during this trial except for a baseline CT/MRI taken to be used for the follow-up study.
Dose escalation design is often applied in oncology studies. OCT has serious experience in this therapeutic area, among others, – more than 40 studies in oncology including 10 trials in patients with breast cancer have been conducted by OCT since 2005 when the company was founded.
Geographical location of OCT operations help us ensure good speed of enrollment in different therapeutic areas including oncology, due to access to a large population of patients in Central and Eastern Europe who are drug naive in several therapeutic areas, since they have not been exposed to many new western drugs. Moreover, both principal investigators and patients in these regions are often more motivated to be involved in clinical studies, than the ones in Western Europe or the US: for the former participation in clinical trials is an opportunity to increase earnings, for the latter – to get scarce and often expensive treatment which could safe their lives.