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
OBJECTIVES:
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
lung cancer.
II. Evaluate the time to progression and overall survival of patients treated with this
drug.
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.
Interventional
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
No
Barbara Gitlitz
Principal Investigator
Beckman Research Institute
United States: Food and Drug Administration
NCI-2009-01159
NCT00400829
November 2006
Name | Location |
---|---|
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
City of Hope | Duarte, California 91010 |