20.Jan.2012

OCT met an interim enrollment milestone in a phase II study

OCT met an interim enrollment milestone of 50% of randomized patients in a phase II study of a novel drug to treat in Metastatic Breast Cancer

OCT met an interim enrollment milestone of 50% of randomized patients in a phase II study of a novel drug to treat in Metastatic Breast Cancer.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute.  In 2010, NCI estimated that 207,090 women were diagnosed with breast cancer, while 39,840 women likely died from the disease.

According to official sources, worldwide, breast cancer comprises 22.9% of all cancers (excluding non-melanoma skin cancers) in women.  In 2008, breast cancer caused 458,503 deaths worldwide (13.7% of cancer deaths in women).
OCT client is sponsoring a controlled Phase II trial in metastatic breast cancer (MBC) subjects who have been previously treated with a taxane and an anthracycline.

Planned enrollment is 140 patients, 130 of them will be enrolled by OCT in Russia.  OCT has reached 50 % milestone in the study. The study is being performed in 15 Russian sites. The study is FDA controlled.   We are very pleased to see the progress in the trial and we hope that the study will lead to drug registration afterwards. OCT is working very closely with the sites in Russia to ensure recruitment goals are met, patient care and the quality of the data being collected is excellent.

We have provided the following services in this study:

  • Clinical Monitoring
  • Project Management
  • Regulatory
  • Investigator Meeting
  • Clinical Supply Management
  • Quality Assurance Services
  • Study Feasibility
  • Safety Management

OCT has been conducting clinical trials in breast cancer since 2006 in different countries of its operation: Russia, Belarus, Ukraine, Latvia, Lithuania, Estonia and Bulgaria. OCT is dedicated to innovative clinical cancer research.

OCT has very extensive experience in oncology:

  • We have experience in the following indications:
  • Breast cancer
  • Prostate
  • Bladder
  • Bone Metastases
  • NSCLC
  • Colorectal
  • Head Neck
  • Ovarian
  • Endometrial cancer