12.Oct.2017

OCT to start a phase III study sponsored by international pharmaceutical company

This is a randomised double-blind study comparing the efficacy and safety of medicinal products in combination with chemotherapy in patients with non-resectable metastatic colorectal cancer.

The enrollment will include male and female patients aged 18-75 years administered first-line treatment for metastatic disease. They will be randomized into two treatment arms. The total duration of subject participation will be approximately 9 months, including a 3-week screening period.

The most commonly diagnosed cancers worldwide are lung cancer, breast cancer, and colorectal cancers (9.7%). The cost of biologic therapies has become increasingly prohibitive. As many regions throughout the world cannot access expensive biologic therapies, research and development of biosimilar products is necessary to provide patient access to safe, effective and more affordable biopharmaceutical products. The investigational drug was developed as a proposed biosimilar.

The efficacy will be measured in terms of progression free survival at 6 months in combination with chemotherapy for mCRC (stage IV) as first-line treatment for metastatic disease.