The study is designed to evaluate the anti-tumor activity of talabostat in combination with gemcitabine in patients with metastatic pancreatic cancer.
The trial design is a single-arm, two-stage study in up to 60 patients with metastatic pancreatic cancer. The primary clinical endpoint will be six-month survival. Secondary study endpoints include overall survival, progression-free survival, quality of life, and performance status.
Don Kiepert, president and CEO of Point Therapeutics said: “Our preclinical work with talabostat in combination with gemcitabine demonstrated encouraging results. Overall tumor rejection rates in mice increased to 45% when treated with the talabostat/gemcitabine combination as opposed to a 23% rejection with gemcitabine alone. We are hopeful that these results will translate into the clinical setting given the lack of options for patients facing pancreatic cancer.”
According to the American Cancer Society, pancreatic cancer is the fourth leading cause of cancer death in the US. In 2005 alone, 32,180 new cases of pancreatic cancer will be diagnosed and 31,800 people will die of the disease.