Orathecin (rubitecan) is an orally active camptothecin that is being developed for the treatment of pancreatic cancer and gemcitabine is a chemotherapy drug sold under the brand name Gemzar by Eli Lilly.
The study will enroll 30 chemotherapy-naive patients at up to 15 centers in the US. Patients will receive combination therapy of gemcitabine and Orathecin capsules, with the trial’s primary efficacy endpoint being 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 CEO 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.”