Date: 2016-05-05
Type of information: Clinical trial authorization
phase: 3
Announcement: clinical trial authorization
Company: Eleison Pharmaceuticals (USA - FL)
Product: glufosfamide
Action
mechanism: alkylating agent. Glufosfamide is a glucose-conjugated prodrug. This third-generation alkylating agent is an analog of ifosfamide, but with greater specificity and a better safety profile, targeting metabolically active tumors and hypoxic tumor regions. It has been evaluated in more than 450 patients in multiple clinical studies. Data from a previous phase III trial indicated a 25% improvement in median survival in a very difficult to treat indication, 2nd line pancreatic cancer, although the study size and trial design was insufficient to prove statistical significance.
Disease: metastatic pancreatic adenocarcinoma
Therapeutic area: Cancer - Oncology
Country: China, USA
Trial
details: The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen. (NCT01954992)
Latest
news: * On May 5, 2016, Eleison Pharmaceuticals announced it has received approval from the China Food and Drug Administration (CFDA) to enroll patients in China under its ongoing Phase III clinical trial of glufosfamide. “New clinical sites will be added in China in the coming months to complement the approximately 20 sites now enrolling the U.S." said Dr. Zhang. VP and head of Business Development in China for Eleison Pharmaceuticals.
Eleison is currently enrolling patients in a pivotal multi-national Phase III study of glufosfamide as second-line therapy for patients with metastatic pancreatic cancer. This pivotal trial is enrolling patients with relapsed or refractory pancreatic cancer following prior chemotherapy treatment. The randomized, open-label trial is being conducted to evaluate the safety and efficacy of glufosfamide, with a target enrollment of 480 patients. The primary endpoint is overall survival with a number of pre-specified secondary endpoints. The trial will exclude insulin-treated diabetic patients.
A key finding of the prior phase III study was the shortened survival associated with glufosfamide treatment of insulin-taking patients (40 of 286 test subjects). Glufosfamide's activity is affected by a patient’s diabetic status and use of insulin. Based on this and other valuable information from the prior study, and with assistance from key clinical oncologist advisors, Eleison has designed a new clinical study and regulatory plan for glufosfamide with a high probability of achieving statistical significance and regulatory approval. Eleison began enrolling patients in this pivotal phase III 2nd line study in 2014, with 30 sites currently open for enrollment in the U.S.
