A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane
I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective
response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell
II. Evaluate the time to progression and overall survival of patients treated with this
III. Evaluate the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats
every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed once monthly for at least 6
months and then periodically thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (CR or PR) according to RECIST criteria
Exact 95% confidence intervals will be calculated for this estimate (reflecting the interim analysis).
Up to 5 years
Beckman Research Institute
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|City of Hope||Duarte, California 91010|