Gloucester Pharmaceuticals, Inc., a privately held cancer therapeutics development company, has enrolled and treated the first patient in a phase I/II clinical study of romidepsin in combination with gemcitabine to treat pancreatic cancer and other solid tumours.
The company anticipates enrolling approximately 30 patients in an open-label, single-arm study. Patients will receive romidepsin and gemcitabine at various doses in order to establish the most appropriate dose for each drug in this combination regimen. Once the appropriate dose of each drug is determined, additional patients will be treated at that dosing regimen. The endpoints for this trial include both safety and objective response to therapy.
"This clinical trial will expand on recent preclinical data suggesting that romidepsin may enhance the activity of gemcitabine," commented Howard Burris, MD, of the Sarah Cannon Research Institute and principal investigator of the study. "Gemcitabine is already approved for the treatment of pancreatic cancer and we hope to find that using it in combination with romidepsin may improve patient outcomes. Despite recent advances, pancreatic cancer is still a leading cause of cancer death in the US and innovative new treatments are clearly needed," he concluded.