OCT has been granted a Phase II, randomized, multi-centre, open-label, active-controlled, dose-finding trial in women with breast cancer receiving myelotoxic chemotherapy. Myelotoxicity in this study will be defined by the duration of moderate neutropenia.
Neutropenia is a granulocyte disorder. The disease is characterized by a low number of neutrophils, which is the most important type of white blood cell. Neutrophils account for 50-70% of circulating white blood cells. Neutrophils serve as the primary defense against infections – they destroy bacteria in the blood. Patients with neutropenia are regarded as more susceptible to bacterial infections, which could cause life-threatening conditions. Standard therapy for neutropenia is recombinant G-CSF (granulocyte-colony stimulating factor) such as filgrastim.
As for the study drug, this will be a recombinant fusion protein with human G-CSF fused to human immunoglobulin IgG2-Fc. The product is delivered by a subcutaneous injection.
This phase II open label clinical study will enroll 200 women with stage II - III invasive breast cancer in up to 35 clinical centers in North America and Europe that will receive chemotherapy treatment.
In OCT countries, namely Russia and the Ukraine, 130 patients will be enrolled within 6 months at 16 investigational sites providing the highest recruitment rate regionally.
The trial will be conducted in compliance with the trial protocol, ICH-GCP Guidelines, and US Code Federal Regulations, CFR Title 21 Food & Drug Administration revised as of April 1, 2006.
This will be a full-service support clinical project, including project management, site selection, clinical monitoring, warehousing, study materials purchase and other logistics assistance, safety management, regulatory activities within the clinical trial approval and export/import licenses obtainment, final report preparation, investigator’s meeting organization, others. The leading international laboratory will be used for biosamples assessment. Total study duration will be around 15 months.
The clinical project is the result of repeat business. OCT will perform the study for an ambitious Chinese pharmaceutical company entering foreign markets. We are glad to expand our partners’ network in all the regions worldwide.
OCT has a great experience in oncology clinical development. OCT will be happy to provide the highest quality level of clinical services.