The trial of approximately 132 subjects will evaluate the effect of weekly Asentar doses combined with gemcitabine plus or minus daily erlotinib in the initial treatment of advanced pancreatic adenorcarcinoma.
The primary endpoint of the trial is to assess the six-month survival rate, with secondary endpoints of objective response rate, duration of progression-free survival and overall survival. In addition, the trial will assess safety and tolerability.
Asentar is the company’s lead investigational product and is also currently in a Phase III clinical trial for the treatment of patients with advanced prostate cancer.
The principal investigator of this trial is Mace Rothenberg, professor of medicine at Vanderbilt-Ingram Cancer Center in Nashville. Schering-Plough will sponsor the trial and Novacea will oversee the execution of the study.
John Curd, Novacea’s president and CMO, said: “As part of Novacea’s development plans for Asentar, we are pleased to open a trial in an area where there is a need for better treatment alternatives. We believe Asentar has the potential to be developed in multiple tumor types and that through rigorous clinical research, we can demonstrate Asentar’s broad potential as a cancer treatment. We are also very fortunate to have Dr Rothenberg as our principal investigator as he is recognized internationally as an expert on clinical trial design and evaluating new cancer treatments.”
Mr Rothenberg said: “This trial will provide us with the first clinical data to determine whether the beneficial effects of adding Asentar to chemotherapy that have been observed in the laboratory translate into clinical benefit for patients with this disease.”