Focusing on pancreatic cancer, we have commenced enrolling patients in a Phase III second-line, multi-center, multi-national, randomized, open-label study designed to evaluate the efficacy and safety of glufosfamide as compared with fluorouracil (5-FU). The primary endpoint is overall survival compared with (5-FU).
Approximately 480 patients at least 18 years of age with metastatic pancreatic adenocarcinoma previously treated with gemcitabine and who are not insulin-taking diabetics will be enrolled. Patients will remain on study therapy until disease progression or prohibitive toxicity occurs. Maximum treatment duration will be 36 weeks. Patients who have not progressed at this time may be permitted to continue therapy on a case-by-case basis at the Investigator’s discretion if considered in the best interests of the patient. All patients will be followed regularly until disease progression or for up to 36 weeks and then will be followed for survival at three-month intervals. Patients in the 5-FU arm may not crossover to glufosfamide treatment.