A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVE:
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
unacceptable toxicity.
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.
Interventional
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
No
Malcolm Moore
Principal Investigator
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration
NCI-2009-00173
NCT00383760
August 2006
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