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Phase 2 Combination Trial of Rubitecan and Gemcitabine Initiated in Pancreatic Cancer Patients
The study will enroll 30 chemotherapy naive patients at up to 15 centers in the United States. Patients will receive combination therapy of gemcitabine and Orathecin capsules, in a dosing regimen of 1,000 mg/m2 gemcitabine weekly for three weeks plus 1 mg/m2 Orathecin capsules taken once daily for five days, with two days off during gemcitabine treatment. The primary efficacy endpoint is overall survival.
"We are very pleased to have initiated this study which will help determine whether chemonaive patients will benefit from a combination of Orathecin and gemcitabine," commented Dr. James Manuso, President and Chief Executive Officer of SuperGen. "Given the extremely high mortality rates for pancreatic cancer, the limited treatment options currently available and the encouraging data in refractory patients, we believe Orathecin combinations could have utility as first-line therapy."
Orathecin(TM) (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor that is being developed for the treatment of pancreatic cancer.
Orathecin has Orphan Drug status in both the U.S. and EU. The Orathecin European filing, or Marketing Authorization Application, contains data from a Phase III clinical program believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,000 patients. A decision from the EMEA on the approval of Orathecin is expected later this year.
About Pancreatic Cancer
According to American Cancer Society Cancer Facts and Figures 2004, 31,860 people will be diagnosed with pancreatic cancer this year in the United States and 31,270 people will die. Pancreatic cancer is the fourth highest cancer killer in the United States amongst both men and women. The 99 percent mortality rate for pancreatic cancer is the highest of any cancer.
Source: SuperGen, Inc.