OCT is announcing the commencement of a Phase II clinical trial in women with breast cancer receiving myelotoxic chemotherapy. The study is located in Russian and Ukrainian sites, which OCT has used in the past and has good contact with.
The client has received FDA regulatory clearance for the randomized, multicenter, open-label, active-controlled trial of the study drug. OCT was responsible for clinical trial approval in Russia and Ukraine. At the moment OCT is getting ready to perform the Investigator’s Meeting for the Russian and Ukrainian sites. OCT is performing site initiation visits for the sites. We hope to have the FPI very soon. The population of patients enrolled in this study will be comprised of women, between 18 and 75 years of age that have been diagnosed with stage II-III invasive breast cancer and are scheduled to undergo TC chemotherapy.
This trial is expected to enroll 200 patients and to be conducted at 35 clinical centers in North America, Russia and Ukraine. It is very well known that enrollment in Russia and Ukraine is much better than in Western countries therefore we think that including the OCT region into the study is an adequate decision.
The primary objective of this study is to analyze the efficacy and safety of various once-per-cycle dosing of the study drug as compared with the standard dosing of pegfilgrastim in breast cancer patients undergoing myelotoxic chemotherapy. Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the level of neutrophils. Pegfilgrastim treatment is used to stimulate the bone marrow to produce more neutrophils to fight infection in patients undergoing treatment using chemotherapy.
Recombinant human G-CSF (rhG-CSF) was developed and used to treat neutropenia, particularly for the management of neutropenia in patients with cancer. The first generation rhG-CSF, filgrastim, received FDA approval in the US in 1991 for treating neutropenia A new generation of filgrasim is a pegylatedfilgrastim,, pegfilgrastim, which received FDA approval in 2002
This is OCT’s second trial for this biologic drug. Several years ago OCT was responsible for a trial using filgrastim analogue. The trial we performed before lead to drug registration in Europe and the USA.