SuperGen Initiates Combination Trial of Orathecin, Gemcitabine

The first patient has been dosed in SuperGen's Phase II clinical trial studying Orathecin capsules and gemcitabine as a first-line combination therapy for advanced pancreatic cancer patients who have not undergone chemotherapy.

Orathecin (rubitecan) is an orally active camptothecin that is being developed for the treatment of pancreatic cancer. The study will enroll 30 chemotherapy-naïve patients at up to 15 centers in the U.S.

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.