Gemzar is an approved chemotherapy, marketed for use in pancreatic, ovarian, lung and breast cancer.
Key objectives for the phase I portion of the study will be to evaluate the compatibility and safety of administering these two agents together, to determine the maximum tolerated dose of MGCD0103 and to define the phase II dose to be administered.
In the expanded phase II portion of the trial, the primary objective is to determine the overall response rate in pancreatic cancer patients. The trial is expected to take 18 to 24 months to complete.
“Intensive chemotherapies such as Gemzar remain the primary therapy for the treatment of most solid tumors, and we know from preclinical models that MGCD013 is highly synergistic with Gemzar, as well as other standard chemotherapies. In addition, to its potential in the improved treatment of pancreatic cancer, this study may also illustrate the utility of MGCD0103 plus Gemzar in other solid tumors where Gemzar is used,” said Patrick Mahaffy, president and CEO of Pharmion Corporation.