A Phase II Open Label Study of E7389 (Halichondrin B Analog) in Patients With Advanced/Metastatic Breast Cancer Previously Treated With Chemotherapy Including An Anthracycline and A Taxane
The primary objective is to determine the response rate (RR) to E7389 monotherapy
administered as an IV bolus of 1.4 mg/m^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days
1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with
chemotherapy including an anthracycline and a taxane, with previously documented progression
during or within six months following the last dose of prior chemotherapy.
The secondary objectives are to evaluate:
- The safety and tolerability of E7389 monotherapy in this patient population;
- The antitumor activity of E7389 as determined by duration of response, time to
progression, and overall survival;
- Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
questionnaire/tumor-related symptom improvement or worsening measured by pain intensity
on a visual analog scale (VAS), analgesics consumption, weight changes and performance
status (PS);
- Tumor pharmacogenetics and their possible relationship to response (assessment of
beta-tubulin isotype mRNA on biopsy sample) in patients who have signed a separate
consent form
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Confirmed 4 to 8 weeks after first observed
No
Dale Shuster, Ph.D.
Study Director
Eisai Inc.
United States: Food and Drug Administration
E7389-A001-201
NCT00097721
September 2004
November 2006
Name | Location |
---|---|
Great Falls, Montana 59405 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Little Rock, Arkansas 72205-7199 | |
Metairie, Louisiana 70006 | |
Jackson, Mississippi |