26.Jan.2012

Clinical trial approval was received for phase II trial in pancreatic cancer

This will be a multi-center clinical study designed to assess the safety, tolerability and efficacy of the targeted antitumor agent in patients with unresectable advanced pancreatic cancer.

OCT have received approval of phase II clinical trial in patients with locally advanced pancreatic adenocarcinoma. This will be a multi-center clinical study designed to assess the safety, tolerability and efficacy of the targeted antitumor agent in patients with unresectable advanced pancreatic cancer. The study will be conducted at up to 30 study sites worldwide while OCT will be responsible for 5 sites in Russia. First patient in is expected by the end of February right after IMP import into Russian Federation.

Pancreatic cancer is one of the most aggressive human malignancies.  About 90% of all pancreatic cancers are adenocarcinomas developed from cells lining the pancreatic duct. Pancreatic cancer is the fourth most common cause of cancer death across the globe and it often has a poor prognosis due to a high rate of local recurrence and metastasis, despite resection. Statistics show that more than 15 000 people are diagnosed with pancreatic cancer in Russia annually. Early pancreatic cancer often does not cause symptoms, and the later symptoms are usually nonspecific and varied.

Soon after the approval of gemcitabine as a standard chemotherapeutic drug for pancreatic cancer treatment in 1998 the world pharmaceutical society started looking for an alternative or supplementary therapy to provide benefits that are competitive with existing treatment method. Despite the substantial number of clinical trials trying to improve benefits of the standard therapy there is still no regimen that can be considered as the preferred choice. Research into treatment of pancreatic cancer is run in many medical centers throughout the world.

OCT have been conducting clinical trials in cancer since 2005 and have broad experience in oncology studies, among which there are several big phase III trials.
We will provide the following services in this study: