A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
I. To determine the objective response (complete and partial) to E7389 in patients with
locally advanced, unresectable, or metastatic pancreatic adenocarcinoma that progressed
after prior gemcitabine hydrochloride-based therapy.
I. To determine the antitumor activity of E7389, in terms of median survival, 1-year
survival rate, response or stable disease duration, toxicity, and time to disease
progression, in these patients.
OUTLINE: This is an open-label, multicenter study. Patients receive eribulin mesylate IV on
days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or
After completion of study treatment, all patients are followed at 4 weeks. Patients with
complete response, partial response, or stable disease are followed every 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (complete and partial) evaluated using RECIST criteria
Up to 3 years
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration